The updated information to the drug’s WARNINGS section reinforces the Boxed Warning that was added to all metoclopramide-containing drugs in June 2009. The new warning states, “Treatment with metoclopramide can cause Tardive Dyskinesia (TD), a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face, tongue, or extremities. The risk of developing Tardive Dyskinesia increases with the duration of treatment and the total cumulative dose. An analysis of utilization patterns showed that about 20 percent of patients who used metoclopramide took it for longer than 12 weeks. Treatment with metoclopramide for longer than the recommended 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing TD.”

Metozolv, as well as all metoclopramide-containing medications, are only available by prescription. Metoclopramide is approved for the treatment of severe heartburn and acid reflux, gastroesophageal reflux disease (GERD), and gastroparesis, or delayed emptying of stomach contents. It is also used off-label to treat morning sickness. Many patients who require metoclopramide have difficulty swallowing. Metozolv is the first metoclopramide treatment available in an orally disintegrating tablet.

SOURCE: Reglan Side Effects › Metozolv label has new tardive dyskinesia warning

Reglan, also known by the generic metoclopramide, is a prescription medication used to treat severe heartburn, acid reflux, gastroparesis and other gastrointestinal problems. Last year, after numerous reports to the Food and Drug Administration (FDA) of patients who took the drug and then developed Tardive Dyskinesia, the FDA ordered that a black box warning be placed on Reglan. The label now warns against long-term use – 12 weeks or greater.

The condition is marked by involuntary movements of the muscles and can include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers. In some cases, it can cause involuntary movements of the legs. Tardive Dyskinesia is debilitating and oftentimes the symptoms do not subside even after the medication has been stopped.

Hundreds of lawsuits have been filed against people who developed the serious movement disorder after taking Reglan or one of its generic equivalents. They say that the makers of the drug were fully aware of the dangers it could cause but they did nothing to warn patients or their doctors until thousands were already suffering from the condition.

SOURCE: Reglan Side Effects › Restless leg syndrome turns out to be movement disorder caused by Reglan

Metoclopramide is approved by the Food and Drug Administration (FDA) to treat severe heartburn, gastroesophageal reflux disease (GERD), and gastroparesis. Last year, the federal agency ordered a black box warning be placed on the drug following reports of a debilitating, involuntary movement disorder known as Tardive Dyskinesia most often associated with long term (greater than 12 weeks) use of the drug. The drug also carries warnings on its safety label of anxiety, depression and suicidal ideation.

Most physicians do not like to prescribe medication to expectant mothers because of concerns of how the drug will affect the unborn child. But as much as 80 percent of pregnant women suffer from morning sickness in the first trimester. For most, the nausea can be managed with small, frequent meals, but for some women, morning sickness can last well past the first trimester putting the mother and baby both at risk from dehydration and lack of nutrition. In such cases, some doctors have turned to off-label prescribing of various medications, including metoclopramide.

Metoclopramide is more commonly used off-label as a treatment for morning sickness in Europe and Israel, but the practice is beginning to carry over to the United States even though there have been no studies backing up the safety of the drug on pregnant women and their unborn children.

But, a new Israeli study, reported in the New England Journal of Medicine, studied a total of 81,703 births among mothers enrolled in Israel’s largest HMO, 3,458 of whom used metoclopramide during their pregnancy. The study showed that there were no significant increases in the incidence of birth defects or low birth weight in the group using metoclopramide, and there was even a slightly lower incidence of stillbirth.

Researchers say the findings provide reassurance regarding the safety of metoclopramide for the fetus when the drug is given to women to relieve nausea and vomiting during pregnancy. However, women who take the drug – whether pregnant or not – should use care and heed the label’s safety warnings as the drug can cause serious, even life-threatening, problems.

SOURCE: Reglan Side Effects › Reglan as morning sickness treatment still carries risks for mom

“My life is unbearable because of Reglan, and if the side effects don’t end soon, I am afraid that I will eventually kill myself,” writes Jodi* on Medications.com bulletin board. “I took Reglan for a month. I gradually began to lose interest in things, couldn’t concentrate, and at the very end of the month became suicidal. It has now been a month since I have stopped taking Reglan, and every day is miserable and joyless. Everyday I cry and think about suicide. The side effects of this medication did not end when I stopped taking it.”

Bobby is also suspicious of Reglan. He wonders if his wife’s suicide was triggered by the drug. “My wife started taking Reglan last year, one week before she committed suicide at the age of 57,” he wrote on Medications.com. “She had never been diagnosed in her life as depressed.”

Reglan’s safety label carries a host of side effects, including the black box warning for Tardive Dyskinesia. Under the “important warnings” section, it also mentions side effects such as “depression” and “thinking about harming or killing yourself.” Perhaps its time for the FDA to issue another black box warning for its popular heartburn drug.

SOURCE: Reglan Side Effects › Reglan users blame depression, suicidal thoughts on heartburn drug

For several months, Gentrie was unable to eat solid food, and in at least one occasion was rushed to the hospital for her severe vomiting and dehydration. It wasn’t until she was had a CAT scan that doctors finally discovered the cause of her painful condition. Gertie was diagnosed with pediatric gastroparesis, a condition in which the stomach takes too long to empty its contents. Gastroparesis is often associated with diabetic patients. Doctors believe Gertie’s condition was triggered by a virus.

There are few treatments for severe gastroparesis. It is often treated with medications such as the prescription drug Reglan, also known as the generic metoclopramide. But Reglan carries a risk of severe side effects, especially with long-term use. The drug now carries a black box warning of the risk of developing a neurological disorder known as Tardive Dyskinesia in which the muscles move involuntarily.

Gertie was treated with various medications, including Botox, but nothing seemed to help. She was even fitted with a gastric tube to help her gain weight, but her frail body rejected it six times. As a last resort, doctors decided on a new treatment, implanting in her a gastric pacemaker that would trigger her stomach muscles to contract and encourage digestion.

With the help of singer Miley Cyrus, Gentrie’s family raised enough money to cover the cost of the pacemaker. It was implanted in July and just last week, Gentrie was finally able to have her first meal in eight months. What did she choose to eat? A Wendy’s hamburger.

SOURCE: Reglan Side Effects › Teenager finally finds relief from gastroparesis

Diabetics

The study is being conducted at institutes in 37 cities in numerous states across the country. Additional criteria to participate includes being 18 years of age or older and free of cancer for five years. Qualified participants will receive all study-related exams and investigational study medication at no cost. Compensation is also provided.

Currently, there are few options for patients who suffer from the painful and often debilitating symptoms of gastroparesis. A restricted diet may help some, but many turn to medications or surgery to help them lead normal lives. However, surgery can be invasive, and even the most common medications to treat gastroparesis, such as Reglan (metoclopramide), come with an FDA black box warning that the drug has been linked to a serious and involuntary movement disorder known as Tardive Dyskinesia. There is no cure for Tardive Dyskinesia and symptoms often persist even after the medication has been stopped.

Clinical trials are medical research studies involving people. The trials look at preventing disease, treatments, diagnosing disease and controlling symptoms, and seek to determine if a new experimental drug or procedure is safe, has side effects, works better than the currently used treatment, and helps patients feel better. New treatments must be thoroughly tested first in the laboratory and then in people before they are approved by the FDA.

For more information about and locations for the nationwide Diabetic Gastroparesis Clinical Trial, visit the Clinical Connection.

SOURCE: Reglan Side Effects › Clinical trial seeks diabetics for new gastroparesis treatment

The numerous responses tell the same story. “My experience with Reglan was absolutely frightening,” says SoCal. “I developed severe Parkinson’s-like tremors and anxiety. And, I don’t even have a history of anxiety. I stopped the drug immediately and was told never to take it again.”

“I had the same experience as SoCal with Reglan,” says Natie. “I developed severe anxiety and tremors within the first day of taking it.”

“I had the same exact experiences,” Miss Lady Bug chimes in. “I stopped taking it but was left with permanent nerve damage. I had to go to Mayo Clinic to find that out,” she says. “Mayo told me that Reglan should be outlawed and that the USA is the only country that even still uses it.”

Reglan was approved by the Food and Drug Administration (FDA) for the treatment of severe heartburn, acid reflux and gastroparesis. After numerous reports of people using Reglan who then developed tardive dyskinesia, the FDA last year added a black box warning to the drug’s safety label. That warning comes too late for many users of Reglan, who are left with the disabling symptoms of tardive dyskinesia, which include lip smacking, tongue thrusting, eye blinking and bulging, and puckering and pursing of the lips, to name a few.

“I would give anything to be able to go back and do it all over again,” Miss Lady Bug says. “The trembling and anxiety was sooo bad.”

SOURCE: Reglan Side Effects › Forum discusses side effects of heartburn drug Reglan

Tardive Dyskinesia is caused by the long-term use of drugs that block dopamine receptors known as dopamine-receptors antagonists or DRAs. Most of the drugs in this category are anti-psychotics used to treat schizophrenia and other mental disorders.

Recently another medication was added to the list of drugs that increase the risk of developing Tardive Dyskinesia – metoclopramide, known by the brand name Reglan. Reglan is a DRA used to treat gastrointestinal disorders ranging from nausea and heartburn to severe acid reflux and diabetic gastroparesis. Reglan now carries a Food and Drug Administration (FDA) boxed warning against long-term use of the drug because of the risk of developing Tardive Dyskinesia.

The condition can be difficult to diagnose because the medications that cause the disorder can also mask the symptoms. Coming off the offending medication can cause symptoms to surface or even improve. But for some, the debilitating symptoms can be permanent. There is no cure for Tardive Dyskinesia, but some have found relief by taking vitamin E, botulinu toxin injections or by taking certain drugs.

If you have questions about any of these medications or are concerned about symptoms you are experiencing, contact your health care professional.

SOURCE: Reglan Side Effects › Drugs that block dopamine receptors can cause Tardive Dyskinesia

Reglan was approved by the Food and Drug Administration (FDA) for the treatment of gastrointestinal conditions such as chronic heartburn, severe acid reflux or GERD, nausea, and gastroparesis. One year ago, after numerous reports of people using Reglan developed the often permanent and debilitating movement disorder, the FDA placed a black box warning on the drug warning physicians and consumers that using Reglan increased one’s risk of developing Tardive Dyskinesia. A black box warning is the strongest warning the agency can give and is reserved for drugs that carry a significant risk of serious or even life-threatening adverse effects.

But Reglan also carries under the WARNINGS AND PRECAUTIONS section of its safety label a risk of developing depression. Some cases are mild, but others can be quite severe and may involve suicidal thoughts or behaviors. Because of this, consumers should tell their health care provider if they have depression or a history of depression. People who are prescribed Reglan should also be monitored for any signs of depression.

If you or someone you know is taking Reglan and has concerns or questions about the medication, contact your health care professional. Any side effects with this or any other medication should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.

SOURCE: Reglan Side Effects › Using Reglan can make you depressed

Tranzyme Pharma’s drug candidate would be an alternative to a drug for gastroparesis that now carries a black box warning. Reglan (metoclopramide) is a prescription treatment for gastroparesis that just recently received an FDA black box warning following reports that linked the medication to a serious and involuntary movement disorder known as Tardive Dyskinesia. A black box warning is the most serious type of warning the agency can issue and is reserved for drugs that carry a significant risk of serious or even life-threatening adverse events.

Alternatively, Tranzyme Pharma reported that all three doses of TZP-102 were effective, safe and well tolerated by participants in the clinical trial. The company is now gearing up for a 12-week study to test the drug’s efficacy and safety in patients who have gastroparesis.

Last month, Tranzyme Pharma announced an agreement with Netherlands-based Norgine to develop and commercialize TZP-101, another treatment for gastrointestinal disorders.

SOURCE: Reglan Side Effects › Diabetic gastroparesis treatment shows well in clinical trials

Reglan (metoclopramide) was approved by the Food and Drug Administration in 1979 for the short term treatment of various gastrointestinal disorders. But last year, after numerous adverse event reports, the FDA issued a black box warning – the strongest of its kind – on Reglan and generic versions of metoclopramide, stating that the medication had been linked to Tardive Dyskinesia. The movement disorder has been most often associated with some antipsychotic drugs, but about a third of the cases of Tardive Dyskinesia are linked to Reglan (metoclopramide).

An estimated two million people take metocloopramide, including children and infants. While it is approved to treat conditions such as severe heartburn, gastroesophageal reflux disease (GERD) and gastroparesis, or the delayed emptying of stomach contents, it also has an off-label use in the treatment of migraine headaches and morning sickness in women who are pregnant.

The makers of Reglan and generic versions of the drug are now facing numerous lawsuits from people like August, who are suffering permanent disability because of the drug. The Macalusoes allege they were never appropriately warned of the risk of developing Tardive Dyskinesia, and now it’s too late.

Source: News Observer

SOURCE: Reglan Side Effects › Man suffers permanent disability from heartburn drug

Wyeth and Schwarz originally developed the brand-name metoclopramide, Reglan. They were released from litigation by U.S. District Judge Marcia A. Crone. The case is expected to be ready for trial by January 2011.

Metoclopramide is a medication approved by the Food and Drug Administration (FDA) in 1989 to treat gastrointestinal conditions such as severe heartburn, gastrointestinal reflux disease (GERD) and gastroparesis, or delayed emptying of the stomach contents. Over the years, the FDA has received numerous reports of users of metoclopramide suffering from Tardive Dyskinesia, and last year the agency issued a black box warning on metoclopramide products warning users that long-term use of the drug – 12 weeks or more – considerably raised one’s risk of developing the movement disorder.

Tardive Dyskinesia is a condition in which a person develops involuntary movements of his muscles. These movements include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, pucker and pursing of the lips, and involuntary movements of the fingers. Symptoms often continue even after the drug has been discontinued. To date, several lawsuits have been filed in courts throughout the U.S. against the makers of Reglan and generic metoclopramide.

SOURCE: Reglan Side Effects › Generic Reglan makers released from Tardive Dyskinesia lawsuit

Researchers with Pediatrix Medical Group analyzed data from 49,777 infants born between 2003 and 2008 with a birth weight of 501-1,500 grams – or 1 to 3 pounds. The goal of the study was to determine the effectiveness of a multi-faceted quality improvement intervention in reducing the use of many medications that have not been adequately studied in this group, that have not demonstrated clinical benefits, or that carry adverse effects to neonatal patients. The medications targeted were the antibiotic cefotaxime, gastrointestinal medications metoclopramide and H-2 blockers, the diuretic spironolactone, and the hormone erythropoietin.

Metoclopramide, known by the brand name Reglan, has never been approved by the Food and Drug Administration (FDA) for use in premature infants. It is prescribed to patients to treat severe heartburn or gastroparesis, a delayed emptying of the stomach contents. The drug carries a black box warning that long-term use (12 weeks or greater) significantly increases one’s risk of a serious and debilitating movement disorder known as Tardive Diskineia.

The study compared baseline medication usage in 2003 to post-intervention usage in 2008. Following the quality improvement intervention initiatives from 2005-2007, researchers found that use of the targeted medications was significantly reduced.

SOURCE: Reglan Side Effects › Quality improvements reduce drug usage among neonatal community

In that time, more and more patients were developing a serious involuntary movement disorder known as Tardive Dyskinesia. Symptoms of the condition include lip smacking, tongue thrusting, eyes blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers. There is no known cure for Tardive Dyskinesia and the symptoms may persist even after the drug has been discontinued. The drug can also mask symptoms, aggravating them after the medicine has been discontinued.

In February 2009, the FDA issued a black box warning on Reglan and all metoclopramide products warning consumers and health care professionals that long-term use (12 weeks or more) of the drug can elevate one’s risk of developing the condition. Some studies show long-term users of Reglan were as much as 20 percent greater risk of developing Tardive Dyskinesia.

Unfortunately for Valerie, she developed Tardive Dyskinesia. Her tongue is enlarged and she can no longer speak. Even though she has discontinued her use of Reglan, the symptoms still persist.

Source: People’s Pharmacy

SOURCE: Reglan Side Effects › Long-term use of Reglan can cause serious neurological problems

In his consolidation request to the administrative director of the courts of New Jersey, Judge Codey warned that more lawsuits against the manufacturers of Reglan would likely increase in the months to come. “Cases have started coming to Essex on a weekly basis.” Plaintiffs have until May 14, 2010 to comment or object to the application for consolidation.

Reglan and its generic metoclopramide are prescribed for the treatment of gastrointestinal conditions such as severe heartburn and acid reflux, gastroesophageal reflux disease (GERD), and gastroparesis, a condition where the stomach takes too long to empty its contents. Long-tern use (12 weeks or longer) has been associated with the involuntary movement disorder Tardive Dyskinesia. Symptoms of the condition include lip smacking, tongue thrusting, eyes blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers. There is no known cure for Tardive Dyskinesia and the symptoms may persist even after the drug has been discontinued.

All lawsuits filed against Reglan allege that the manufacturers of the drug did note adequately warn consumers of the elevated risk of Tardive Dyskinesia with taking the medication.

SOURCE: Reglan Side Effects › New Jersey judge calls for consolidation of Reglan lawsuits

When we first told you about Mary, she was gearing up for an innovative surgery that would place a device called the Enterra into Mary’s abdomen. Her doctor, Richard McCallum, founding chair at the Paul Foster School of Medicine at Texas Tech University, called it a very powerful anti-nausea, anti-vomiting tool. For Mary, it was a glimmer of hope. “Even if my symptoms got 50 percent better, it would be a huge change in my day,” she said. 

Milder cases of gastroparesis can be treated through diet changes, however many sufferers must turn to medications such as Reglan (metoclopramide). But medication is not always an option for patients who must be on them for several months or years. Reglan has a black box warning against long-term use of the drug (more than 12 weeks) because it can cause a serious movement disorder known as Tardive Dyskinesia.

For Mary, surgery seemed to be the most logical solution.

Just days after surgery, Mary told News Channel 9 that her dreams were realized. She is able to eat and drink things she wouldn’t have even dared to try before surgery. “I’ve been eating ice cream every night, so it’s a whole new world,” she said.

SOURCE: Reglan Side Effects › Gastroparesis sufferer finds relief through surgery

The letter goes on to say that “these violations are concerning from a public health perspective because they suggest that Metozolv ODT is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience, and encourage use in circumstance other than those for which the drug has been shown to be safe and effective.”

The FDA approved Metozolv in September for the treatment of GERD, gastroparesis, and other acid reflux conditions. It is the first fast-dissolving version of metoclopramide, a drug also known by the brand name Reglan. Its projected annual sales could reach $50 million.

Last year the FDA ordered a black box warning be placed on Reglan after numerous reports of a serious involuntary movement disorder known as Tardive Dyskinesia developing in patients who took Reglan. The same black box warning was to be placed on Metozolv when it became available in the U.S. However, upon review, the FDA says Salix fell short of adequately warning patients of the risks associated with Metozolv.

The FDA is ordering Salix to immediately stop the dissemination of the violative promotional materials for Metozolv and to submit a written response to its warning letter explaining how the company will comply with the agency’s request. Failure to correct the violations could result in regulatory action, including seizure or injunction without further notice.

SOURCE: Reglan Side Effects › FDA warns makers of acid reflux drug to change warning label

Mary suffers from gastroparesis, a condition in which the stomach takes too long to empty its contents. It is a debilitating condition that can strike anyone, but people with diabetes are more susceptible. As many as 50 percent of people with type 2 diabetes and 20 percent with type 1 diabetes have the gastrointestinal disorder.

Treatment for gastroparesis can be discouraging. Some people can manage the condition by limiting their diet. Others must rely on medications, such as Reglan (metoclopramide), which can have serious side effects such as a involuntary movement disorder known as Tardive Dyskinesia.

With little hope left, Mary chose another option – to have an innovative new surgery available at Texas Tech University’s Paul Foster School of Medicine. As part of the surgery, doctors will implant a device called the Enterra into Mary’s abdomen. “It’s a very powerful anti-nausea, anti-vomiting tool,” gastroneurologist Richard McCallum, founding chair at the Paul Foster School of Medicine, told KTSM-TV.

Mary’s surgery will be third of its kind performed at the El Paso medical center. “Even if my symptoms got 50 percent better, it would be a huge change in my day,” Mary said.

SOURCE: Reglan Side Effects › Woman to have innovative new surgery to treat gastroparesis

Such research could help the approximately 5 million people who suffer from gastric mobility disorders such as gastroparesis and chronic intestinal pseudo-obtruction. People with these conditions “suffer from the debilitating effects of chronic nausea, vomiting, abdominal pain, malnutrition, dehydration, and weight loss. Many cannot eat a bite of food or take a sip of fluid without getting sick. Some patients are disabled and completely homebound, relying on artificial nutrition in order to stay alive,” according to G-PACT.

Treatments for these conditions are mostly limited to medications, like Reglan (metoclopramide), which cannot be used on a long-term basis without putting users at risk for serious side effects.

“Having been a skin cancer
 sufferer, we would expect Mr. McCain to have a better understanding of
 the struggle that chronic disease sufferers have to live a normal life,
 maintaining careers, families and health,” the petition states. “We also implore others in public life to work to help in our fight to 
gain further understanding, awareness and most importantly cures of GI 
motility disease that all too often causes pain and starvation to 
individuals who did not seek such illness and who did not choose this
 fight.”

To join this fight, sign the petition.

Source, About.com

SOURCE: Reglan Side Effects › Gastroparesis group to petition Sen. McCain about criticism of IBS funding

However, it took more than a decade for the Food and Drug Administration (FDA) to place a black box warning on the medication, Reglan. A black box warning is the strongest warning issued by the FDA and is placed on drugs that have potentially harmful or deadly side effects. Meanwhile, the drug was dispensed 6.5 million times in 2008 to an estimated 2 million Americans.

Reglan, also known by the generic brand metoclopramide, is available in formulations including tablets, orally dissolving tablets, syrups and injections. It works by increasing muscle contractions in the upper digestive tract, which speeds up the rate at which the stomach empties into the intestines. But it also can lead to involuntary movements of the muscles, causing users to smack their lips, thrust their tongue, blink and bulge their eyes, jerk their heads, and purse their lips. Tardive Dyskinesia is debilitating and often symptoms don’t subside even after the medication has been discontinued.

So, why would it take the FDA so long to issue a warning about a medication with published reports of serious adverse events? Herb Denenberg with the Philadelphia newspaper The Bulletin, says delayed action by the government agency is not uncommon.

“This delayed warning of a drug’s danger is all too typical. It took (13) years for the FDA to sound this alarm put forth by Worst Pills, Best Pills News in 1996, thus needlessly exposing many millions to a serious side effect that might plague them for life, and might have been avoided if they were properly warned,” Denenberg argues. “I’d add to that warning. First, everyone should understand, as the Physicians’ Desk Reference explains, that side effects from the drug are unpredictable. The medication guide for Reglan states: ‘It is not possible for your doctor to know if you will get TD [Tardive Dyskinesia].’ So even short-term use may cause Tardive Dyskinesia. Second, the patient – not the doctor or the FDA – should decide whether the benefits of the drug are worth the risks of taking it. The patient should ask the doctor if there are other treatments, including other drugs that might be better options, or perhaps non-drug treatments that might be much safer.”

SOURCE: Reglan Side Effects › Why did FDA take so long to place black box warning on Reglan?

“This is a significant finding, as it shows that loss of the enzyme that makes carbon monoxide is the actor in this process and that it provides us with a clear approach toward a possible new therapy for this condition,” says Gianrico Farrugia, M.D., Mayo Clinic gastroenterologist and lead investigator on the study, in a Science Daily report.

Gastroparesis is a serious condition that causes pain, nausea, vomiting, stomach spasms, weight loss and nutritional deficiencies. It is usually treated through diet, medication or surgery. Treatments are often unreliable or not recommended for long-term use. Finding a way to reverse the condition would give hope to millions of people who are suffering from the effects of gastroparesis.

As part of the study, researchers studied 10 mice that exhibited delayed gastric emptying. Five were given carbon monoxide by inhalation (100 parts per million) for six hours daily. Within three weeks, gastroparesis was reversed in the mice who received the therapy. While the metabolite that normalizes gastric functioning was not known, using carbon monoxide to treat the mice was a hunch on the part of scientists based on previous studies by the team that showed that gastroparesis is associated with the loss of up-regulation of the heme oxygenase-1 (HO1) and an increase in oxidative stress. In the previous study, the team noted that when they induced HO1 production signs of oxidative stress dropped and gastroparesis was restored.

SOURCE: Reglan Side Effects › Study may lead to new treatment of gastroparesis

The Fifth Circuit upheld a lower court ruling that Actavis Inc., could face claims made by Julie Demahy, of Louisiana, who said the drug maker should have warned her of risks of serious adverse events associated with metoclopramide, a medication used to treat heartburn, GERD and gastroparesis, and known by the brand name Reglan. Demahy claimed she suffered a debilitating movement disorder known as Tardive Dyskinesia after taking metoclopramide, and that the drug company failed to alert her of any risks associated with the medication or to change the drug’s labeling to warn of the risk of developing the disorder.

Last year, the Food and Drug Administration (FDA) ordered a black box warning on metoclopramide prescriptions after reports of Tardive Dyskinesia were associated with use of the medication. Long-term use of 12 weeks or more increased one’s risk of developing the disorder to 20 percent or more.

SOURCE: Reglan Side Effects › Ruling: patients may sue generic drug makers under state law

Click here to view the embedded video.

People of all ages, shapes and sizes suffer from gastroparesis. The National Institutes of Health estimates as many as 10 million people are living with gastroparesis. Because of the lack of medical education and improper diagnosis, many more may be suffering in silence. Symptoms include abdominal cramps, nausea and vomiting and can result in dehydration, electrolyte imbalances and malnutrition.

Treatments include medication, such as Reglan (metoclopramide), and surgery. Those with gastroparesis suffered yet another blow this year when the Food and Drug Administration (FDA) issued a black box warning on Reglan after numerous cases of a serious movement disorder known as Tardive Dyskinesia were reported in patients who took Reglan. Long-term users were as much as 20 percent at risk of developing the condition.

Because treatments offer only temporary benefits to patients, activists groups such as the Gastroparesis Awareness Campaign Organization are working to raise awareness in hopes of finding better, safer treatments and, eventually, a cure.

SOURCE: Reglan Side Effects › Gastroparesis organization raises awareness through video

Gastroparesis is a serious condition in which food takes too long to move through the stomach. It can result in pain and disability as well as poor nutrition. Those who suffer are usually treated with medication. But sometimes the medication does not work or can cause serious side effects.

One such treatment is metoclopramide, known in the U.S. by the brand name Reglan. While it can provide relief to some patients, long-term use of metoclopramide has been linked to a serious movement disorder known as Tardive Dyskinesia. Those who suffer from the condition have involuntary movements of their muscles which can include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers.

Medication wasn’t working for Munshi, but she found relief through the Internet in another from, a gastric pacemaker that is implanted in the stomach that shocks the stomach muscles to contract. After surgery, Munshi says doctors gave her tomato soup, but the patient felt so much better that when she got home she devoured her favorite dish – saag aloo. “Everything tastes great now and I haven’t been sick since,” she says.

Sources:
The Metro
The Sun

SOURCE: Reglan Side Effects › Pacemaker gives hope to sufferer of gastroparesis

Patients who suffer from regular vomiting, stomach pain or trouble swallowing are usually given diagnostic tests such as endoscopies, biopsies and CT scans. Some patients are sent to other cities for more advanced testing. With the opening of El Paso’s new clinic, patients who suffer from serious gastrointestinal conditions have more options for specialized care.

“Rather than sending patients to the Mayo Clinic, we can take care of them right here,” says Dr. Richard McCallum, a gastroenterologist and chairman of the Department of Internal Medicine at El Paso’s medical school, in an interview with the El Paso Times. “We offer a very cutting-edge array of the best tests to diagnose the disorders.”

These tests include an esophageal motility test to measure the muscles and pressure of the esophagus; and a gastric emptying test and an ingestible SmartPill, both of which monitor how quickly food leaves the stomach. “These are a series of tests the average hospital and (doctor’s) office do not have,” Dr. McCallum says.

The center will also conduct medical students for new drugs and treatments for various gastrointestinal conditions, including gastroparesis, a condition in which the stomach empties its contents too slowly causing pain, disability and nutritional problems for those who suffer from the condition.

SOURCE: Reglan Side Effects › New medical center to focus on gastrointestinal disorders

Dystonia is a neurological movement disorder that can be disabling. Those who suffer from the condition experience muscle contractions that cause twisting and repetitive movements or abnormal postures. The causes are not completely known or understood, but it is believed to be either inherited or caused by factors such as birth-related or physical trauma, infection, poisoning (such as lead poisoning), or reaction to drugs (such as Reglan, also known as metoclopramide, a common medication to treat heartburn, GERD and gastroparesis). For one athletic young woman, the cause was likely due to a seasonal flu shot.

25-year-old Desiree Jennings, who was training to be a professional football cheerleader, got a flu shot in August. Ten days later she began suffering from dystonia. Now she cannot walk or talk without difficulty. Oddly, she can run seemingly normally. While running she can talk normally, too. She can even walk backwards without the excessive movements. But when she stops or begins to move forward, the jerking movements come back.

Reactions to the flu shot like Jennings’ is rare, but the risk of developing a type of dystonia is greater with some medications. For example, the Food and Drug Administration earlier this year issued a black box warning on Reglan after reports of patients who took the medication began suffering from a type of dystonia known as Tardive Dyskinesia. Up to 20 percent of consumers who took Reglan for more than 12 weeks contracted the disorder. Now the drug’s label warns users against long-term use, but the warnings come too late for too many who are suffering just like Jennings.

SOURCE: Reglan Side Effects › Woman suffers from movement disorder after getting flu shot

More and more cases of consumers taking metoclopramide and subsequently developing Tardive Dyskinesia were reported to the Food and Drug Administration (FDA), and by early 2009, the agency had ordered a black box warning be placed on the medication. New warnings and precautions were written into the drug’s packaging that included an up to 20 percent risk of patients developing Tardive Dyskinesia during long-term use of the medication.

But the warnings came too late for Conte, and for her doctor, who she alleges was unaware of the risks because Reglan’s maker, Wyeth, disseminated misleading and/or incomplete warnings about the drug’s side effects. She sued Wyeth, claiming the company knew of a widespread tendency among physicians to mis-prescribe Reglan and generic metoclopramide for long periods of time even though the medication is only approved for 12 months of use. The drug’s labeling, her lawsuit claimed, substantially understated the risks of serious side effects from extended use.

Initially, the trial court ruled in favor of Wyeth, which argued that it was the physician’s duty to warn patients of any ill effects drugs may have on patients. Conte appealed, arguing the drug’s manufacturer should be responsible. The Court of Appeal concluded that Wyeth was obligated to disseminate accurate product warning labels.

Source: Sierra Sun

SOURCE: Reglan Side Effects › Women suffering from movement disorder sues Reglan maker Wyeth

Last month, the FDA issued a black box warning on the injectable form of promethazine hydrochloride. Promethazine hydrochloride, once sold under the now-discontinued brand name Phenergan, is available in generic formulations in the form of tablets, liquid, rectal suppository, intravenous injection and intramuscular injection. The black box warning cautions health care providers against administering the IV injection into an artery or under the skin because gangrene or other severe tissue injury can result. It also can leach out from the vein during IV administration, causing serious tissue damage.

Another anti-nausea medication is metoclopramide, known by the brand names Reglan and Metozolov. The drug can be administered by injection, or taken as a pill by mouth. Metoclopramide is also a treatment for gastrointestinal conditions such as gastroparesis and GERD. Earlier this year, an FDA black box warning was placed on metoclopramide after long-term use of the drug was linked to a serious and debilitating involuntary movement disorder known as Tardive Dyskinesia.

Tardive Dyskinesia is identified by involuntary head jerking, eye blinking, facial grimacing, pucker and pursing of the lips, lip smacking and tongue thrusting. It may also involve involuntary movements of the fingers and hands. There is no known cure for Tardive Dyskinesia, even after the medication has been discontinued.

SOURCE: Reglan Side Effects › Anti-nausea drugs carry black box warnings

This is promising news, considering there are no FDA-approved drugs to treat morning sickness, and drugs once thought safe for unborn babies, such as Thalidomide and Bendectin, were later linked to serious birth defects such as limb deformities.

Critics argue that there is not enough good-quality evidence that metoclopramide is safe for pregnant women or that it is effective in curtailing nausea and vomiting. One study of 40 women found that steroids worked better than metoclopramide for women, resulting in fewer times a woman vomited and eliminating the need for hospitalization.

Another concern about metoclopramide is the black box warning that is now on the drugs. The new labeling warns patients treated with metoclopramide of the risk of developing a serious and debilitating involuntary movement disorder known as Tardive Dyskinesia. The symptoms, which include jerking, facial twitches and involuntary movements of the hands and tongue, often do not go away after treatment is discontinued.

The risk of Tardive Dyskinesia is even greater for patients who take the metoclopramide for 12 weeks or longer, with some studies showing as many as 20 percent of long-term users developing the condition.

Serious morning sickness can cause problems for both the mother and her unborn child, which is why women who suffer from morning sickness should thoroughly discuss their treatment options with their physician to better understand the benefits and risks.

SOURCE: Reglan Side Effects › Pregnant women should weigh risks of morning sickness medications

What Brittney wants people to understand is what being sick with a chronic illness means. Sure, the condition has left her with a slim figure which has earned her compliments in this society where “skinny” is “in.” But she is far from lucky, she says. “It drives me insane.”

It is unlikely her condition will improve. And people who suffer from gastroparesis have few treatment options. Some people can manage their condition with diet. Others must rely on medication or surgery. But there are risks to surgery, and even the medication raises concerns.

One popular medication for gastroparesis is metoclopramide, known by the brand name Reglan. Earlier this year the Food and Drug Administration (FDA) issued a black box warning on the drug after it was linked to a serious movement disorder known as Tardive Dyskinesia. The debilitating condition often doesn’t go away even after treatment has stopped.

There are several other illnesses besides gastroparesis that fall under the “invisible illness” umbrella, such as Fibromyalgia and scleroderma. For Brittney, raising awareness for such conditions brings her hope that better treatments will be found and she will be able to lead a more normal life. For activities and forums as part of Invisible Illness Week, go to InvisibleIllnessWeek.com.

Source: Journal Star

SOURCE: Reglan Side Effects › Sufferers of chronic conditions raise awareness for invisible Illness week

The Gastroparesis, etc… blogger was diagnosed with the condition in 2004, and in that time has gathered a great deal of information on treatments for the debilitating condition, which she readily shares on her Web site. Gastroparesis is individualized and a treatment that works for one person may not work for another, she says.

She has tried a long list of treatments from Botox to acupuncture to Reglan, but few have worked well for her. She will receive a gastric neurostimulator, also known as a gastric pacemaker, next week. “It took four months to get the procedure approved by my insurance company, but in that time I gained a great deal of knowledge and collected a plethora of resources which I am anxious to pass along.”

The blogger also passes on to her readers information about new treatments and drug warnings, such as the recent black box warning on metoclopramide, also known by the brand name Reglan, and the newly approved Metozolv ODT, an orally disintegrating version of the same medicine. The black box warning notifies patients and health care workers of an increased risk of a serious movement disorder known as Tardive Dyskinesia associated with long term use of metoclopramide.

Whatever course of treatment sufferers of gastroparesis choose, the blogger offers this advice: “Be your own advocate. Truly, in every way. Do your own research. Try everything for yourself. And never, ever give up!”

SOURCE: Reglan Side Effects › Gastroparesis sufferer urges, Never give up!

Gastroparesis is unpredictable – there are good days and bad, making it hard to manage. There is often no explanation for a drastic change in symptoms from one moment to the next. Because sufferers often do not look sick, gastroparesis, called a “silent illness,” is often disregarded by those who don’t understand it.

G-PACT, www.g-pact.org, is an organization that was founded in 2001 to help increase awareness of gastroparesis and another serious gastrointestinal motility disorder, chronic intestinal pseudo-obstruction (CIP), in an effort to seek funding for better research into the causes of and treatment for the disorder. The site also gives sufferers a community where they can share personal stories and triumphs.

G-PACT aims to help find more options for suffers of serious GI motility disorders. “These conditions are not just inconveniences. They are disabling, and in some instances, can even be fatal,” according to the Web site. “There are few treatment options available, and even those have complications and limited effectiveness. Little attention has been given to these illnesses for research due to lack of awareness of the need.”

One of the few treatments available for gastroparesis is metoclopramide, sold in the U.S. under the brand name Reglan. Earlier this year, the Food and Drug Administration (FDA) issued a black box warning on the drug after numerous reports of a serious movement disorder known as Tardive Dyskinesia were associated with the long term use of Reglan.

According to the organization’s Web site, “GI motility disorders are under-recognized, so therefore ignored by many medical companies, pharmaceutical companies, and the FDA.”

SOURCE: Reglan Side Effects › Organization raises awareness, funding for GI motility disorders

Reglan was first approved by the Food and Drug Administration in 1980 to treat GERD and gastroparesis, or delayed stomach emptying. According to The People’s Pharmacy, “Although doctors were warned early on that this drug could cause a neurological disorder, it took the Food and Drug Administration almost 40 years to issue a black box warning about this complication.”

That warning of an increased risk of Tardive Dyskinesia with long-term use of Reglan was issued on February 26, 2009, and the makers of Reglan were ordered to add it to the medication’s labeling. The condition is characterized by involuntary repetitive movements of the extremities, lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. Even after medication has been discontinued, symptoms may still persist.

More than 2 million Americans use some form of Reglan, and as many as 20 percent suffer from Tardive Dyskinesia. If you or a loved one have suffered from side effects of Reglan, you may have a claim against the manufacturer.

* names have been changed.

SOURCE: Reglan Side Effects › Long term use of Reglan linked to serious movement disorder

Salix Pharmaceuticals

Salix hopes to gain full FDA approval to market Metozolv as a short-term therapy (4-12 weeks) for adults with symptomatic, documented gastroesophageal reflux (GERD or heartburn) who fail to respond to conventional therapy, and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis, or delayed emptying of the stomach. Salix currently has 96 salespeople and wants to hire and additional 64 people to its sales force this year to help push the new product.

Drugs for such gastrointestinal ailments as gastroparesis are few and far between and not without their issues. It remains to be seen if when Metozolv hits the market, it will carry the same black box warning already on Reglan, an oral tablet form of metoclopramide that is swallowed. The boxed warning came after it was revealed that long-term use of the drug was linked to a serious involuntary movement disorder known as Tardive Dyskinesia. There is no known cure for the condition, and symptoms may persist even after the medication has been discontinued.

Source: The News & Observer

SOURCE: Reglan Side Effects › Salix plans to increase sales force to push new gastroparesis drug

Scleroderma is a chronic and disabling connective tissue disorder that involves changes in the skin, blood vessels, muscles and internal organs. For most, the condition is progressive. If the gastrointestinal tract, heart, kidneys or lungs are involved, the condition can be fatal. Secondary conditions resulting from scleroderma include gastroparesis and pulmonary hypertension.

The Scleroderma Research and Awareness Act, co-sponsored by Senator Charles Schumer (D-NY) gives hope to the 300,000 Americans and their families living with this disease. The legislation specifies:

1. Directing the National Institute of Arthritis and Musculoskeletal and Skin Diseases at the National Institutes of Health to expand research related to scleroderma. Priority areas would include:

• Development and evaluation of new treatments.
• Research on the relationship between scleroderma and secondary conditions including: pulmonary hypertension, gastroparesis, Raynaud’s phenomenon, and Sjogren’s syndrome.
• Establishment of family and “childhood-onset” patient registries.
• Support for the training of new investigators.

2. Directing the Centers for Disease Control and Prevention to establish a scleroderma public awareness campaign highlighting disease symptoms, prevalence, related conditions, and the importance of early diagnosis.

Treatment for scleroderma includes corticosteroids, immunosuppressants and NSAIDs. Other treatments for specific symptoms, such as heartburn and gastroparesis, include antacids or Reglan (metoclopramide), medicines to improve breathing, and blood pressure medications.

SOURCE: Reglan Side Effects › Scleroderma bill will raise awareness, fund research

Gastroparesis can cause symptoms such as abdominal pain, nausea, early fullness while eating meals and heartburn and can lead to weight loss and poor absorption of nutrients. Some studies have shown that women are as much as seven times more likely to suffer from gastroparesis than men, but the reason is unknown. It is also suspected that more people actually suffer from the condition because symptoms may overlap with other conditions such as irritable bowel syndrome and GERD.

Some people can manage their symptoms with diet or medication, while others may suffer so severely they may require hospitalization. Patients are usually instructed to avoid high-fiber foods, and others may require switching to a liquid diet to maintain hydration. Medication offers only temporary relief at best. For example, long term use of a popular treatment for gastroparesis, Reglan (metoclopramide), can result in a serious involuntary movement disorder called Tardive Dyskinesia.

The best defense to keep symptoms at bay, says Dr. Linda Lee, board certified in internal medicine and gastroenterology and director of the Johns Hopkins Integrative Medicine and Digestive Center, is following a low-fiber diet, taking medications in moderation, and addressing anxiety and depression, which can exacerbate symptoms.

SOURCE: Reglan Side Effects › Women more likely than men to suffer from gastroparesis

Gastroparesis is a digestive disorder in which the stomach takes too long to empty its contents. Literally, gastroparesis means “stomach paralysis,” and those who suffer from the condition can suffer a host of conditions including bloating, nausea, early fullness while eating meals, heartburn, and epigastric pain. Weight loss and poor absorption of nutrients are also serious are other serious outcomes of the disease.

Only a few medications are available to treat gastroparesis, including metoclopramide, domperidone, erythomycin and cisapride.

Metocloparmide, known in the U.S. by the brand name Reglan, works to stimulate stomach contraction. Reglan, however, has been linked to a serious and debilitating involuntary movement disorder called Tardive Dyskinesia, and now carries a black box warning.

Domperidone is similar to metoclopramide but does not carry the same risk of Tardive Dyskinesia. Domperidone is available in Mexico, Canada and some European countries but is not yet available in the U.S.

Erythomycin is a common antibiotic that works to stimulate receptors in the intestines and stomach. Most patients have a high likelihood of developing tolerance to the medication.

Cisapride is a medication that binds to serotonin receptors in the stomach wall and encourages the contraction of the stomach muscles. In the late 1990s, the medication was taken off the market because of complications of cardiac arrhythmia in patients who used the drug. The drug is back on the market for limited use and is not recommended for people with underlying kidney or heart disease.

An emerging therapy is showing promise for people who suffer from gastroparesis. Octreotide, a medication used to treat diarrhea, has been shown in a study among patients with scleroderma to speed up the emptying of stomach contents. Another study indicated the medication decreased the uncomfortable sensation of fullness following a meal. While the studies look promising, researchers say more studies are needed to determine if octreotide is a viable option for patients with gastroparesis.

Source: American College of Gastroenterology

SOURCE: Reglan Side Effects › Gastroparesis treatments offer little relief

The condition in which the stomach takes too long to empty its contents, most often is caused by diabetes but has been associated with infections, endocrine disorders, connective tissue disorders such as scleroderma, autoimmune conditions, neuromuscular diseases, cancer, radiation treatments applied to the chest or abdomen, some forms of chemotherapy, and surgery of the upper intestinal tract. People with eating disorders such as anorexia or bulimia may also develop gastroparesis.

Those with gastroparesis suffer from a host of symptoms such as discomfort of feeling too full too soon after eating a meal, heartburn, nausea and vomiting. Poorly digested food also can collect in the stomach and form a bezoar, a mass of undigested matter that may cause a blockage that can prevent the stomach from emptying, resulting in pain and nausea. The bothersome symptoms of gastroparesis can result in weight loss and poor absorption of nutrients, which makes diet and nutrition of the utmost importance to those with the condition.

Few medications are available for people with the condition, and most carry serious side effects. For example, Reglan (metocloparmide) was recently linked to a serious involuntary movement disorder known as Tardive Dyskinesia. The medication now carries a black box warning. Such warnings leave many searching for better ways to control their gastroparesis.

Some foods are more difficult for the stomach to digest, such as fatty or fibrous foods such as raw vegetables. People with gastroparesis should reduce their intake of fibrous foods or eliminate fiber from their diet altogether. If one chose to eat foods high in fiber, he should be sure to chew the food well and cook it until tender. If necessary, solid food can be pureed in a blender to ease digestion.

Thick and thin fluids such as puddings and nutritional drinks tend to pass well through the digestive tracts of those with the condition. Supplemental nutrition drinks are among the best choices for those with gastroparesis because they can provide important nutrients for the body that one may not be able to get with such a limited diet.

Source, American College of Gastroenterology

SOURCE: Reglan Side Effects › Diet, nutrition key for people with gastroparesis

The patient suffers fro gastroparesis, a condition in which the stomach empties its contents too slowly. It often affects people with diabetes. However, in as many as 60 percent of children with the condition, the cause is unknown.

The procedure involves inserting the pacemaker into the abdomen and placing the electrical wires attached to the device on the stomach. Electrical impulses stimulate the stomach after eating, encouraging the stomach to empty its contents.

“The initial settings are fairly low and, as with a pacemaker in the heart, we can change the settings as needed,” said pediatric surgeon Steven Teich, MD, surgical director of the Bariatric Surgery Program at Nationwide Children’s Hospital and clinical assistant professor of surgery at The Ohio State University College of Medicine.

Pacemakers have been used to treat gastroparesis in adults and results have been promising. “In patients who have received this type of treatment, nearly all symptoms were resolved within two weeks,” said said pediatric gastroenterologist Hayat Mousa, MD, medical director of the Motility Center at Nationwide Children’s Hospital and Associate Professor of Clinical Pediatrics at The Ohio State University College of Medicine.

The procedure takes the place of other, less effective treatments, commonly the medication metoclopramide known in the U.S. by the brand name Reglan. Reglan can only be used for short terms, as long-term use has been linked to a serious and debilitating involuntary movement disorder known as Tardive Dyskinesia. Earlier this year, the Food and Drug Administration (FDA) placed a black box warning on the medication alerting patients and health care professionals of the serious risk when using the medication for more than 12 weeks.

Other medications used to treat gastroparesis include antibiotics, which also carry a list of side effects. “None of these options are really that effective. Hence, the need for better treatment with the gastric pacemaker,” says Dr. DiLorenzo, Chief of Gastroenterology at Nationwide Children’s Hospital.

Source: DotMed News

SOURCE: Reglan Side Effects › Procedure shows promise versus drugs for children with gastroparesis

Diabetes can cause damage the vagus nerve when blood glucose levels remain high over a long period of time by damaging the blood vessels that carry oxygen and nutrients to the nerves. According to the American Diabetes Association, symptoms of gastroparesis include heartburn, nausea, vomiting of undigested food, an early feeling of fullness when eating, weight loss, abnormal bloating, erratic blood glucose levels, lack of appetite, gastroesophageal reflux or spasms of the stomach wall.

Gastroparesis is often treated by managing blood glucose levels as best as possible through insulin, oral medications or a change in diet. Medications also can be prescribed to help encourage digestion, such as metoclopramide, known by the brand name Reglan.

As with any medication, patients should be aware of any adverse reactions they experience while taking medication, and this is especially true with Reglan (metoclopramide). Earlier this year the Food and Drug Administration (FDA) issued a black box warning, the stiffest warning the FDA can require, after studies have shown that people taking metoclopramide can develop a serious condition known as Tardive Dyskinesia, in which a person develops involuntary movements of their muscles, particularly of the face and fingers.

Patients taking Reglan (metoclopramide) should consult their health care provider if they experience any adverse reactions to the medication. If you have been injured by Reglan (metoclopramide) side effects, you may have a claim against the manufacturer.

SOURCE: Reglan Side Effects › Patients with gastroparesis should weigh treatment options

Diabetes is just one of the known causes of gastroparesis. The condition is generally treated through dietary changes and medications including metoclopramide, which is commonly found under the brand names Reglan, Maxolon or Clopra and is traditionally available in the form of a tablet,  oral solution or injection.

The clinical trail on Questor’s Emitasol metoclopramide nasal spray showed encouraging results in terms of safety and preliminary evaluation of efficacy in the treatment of diabetic gastroparesis. No serious adverse events were reported during the trial.

In recent months, the Food and Drug Administration (FDA) placed a black box warning on the drug metoclopramide – the strongest warning required by the FDA – after a serious condition called Tardive Dyskinesia was reported in a number of patients who took the drug. Tardive Dyskinesia is a Parkinson’s-like condition in which a person develops involuntary movements of his muscles, including lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, lip puckering and involuntary movements of the fingers. The condition can be permanent, even after the drug has been discontinued.

Questor says it plans to begin Phase III of the Emitasol study as soon as possible.

Source: PR Newswire

SOURCE: Reglan Side Effects › Clinical trial underway for metoclopramide nasal spray