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

“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

Tardive Dyskinesia is an involuntary movement disorder that causes repetitive movements of the face and limbs. These movements include lip smacking, grimacing, tongue protusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movements of the fingers. It is a debilitating condition whose symptoms often do not go away even after the offending medication has been stopped.

Metoclopramide was originally used to treat psychosis in patients, but the drug showed more promise in controlling gastrointestinal disorders and is now largely used for this purpose. Neuroleptic drugs like metoclopramide, which also includes anti-psychotic drugs, have been associated with movement disorders and other serious side effects since the 1990s.

In 2000, Cisapride, another anti-psychotic drug that was also released as a gastrointestinal medication, was discontinued after it was found to cause cardiac complications in patients treated with the medication. This likely delayed the reporting of adverse events associated with metoclopramide.

Until the black box warning was issued earlier this year, metoclopramide safety labels indicated Tardive Dyskinesia was a rare side effect and did not warn against long-term use of the drug. In the interim, doctors freely prescribed the drug without knowledge of the serious problems it could cause over time. As a result, hundreds of people have filed suit against the makers of metoclopramide claiming they were not adequately warned of the dangers of taking the heartburn medication.

SOURCE: Reglan Side Effects › Long-term use of heartburn drug can cause serious movement disorder

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

Reglan is a medication commonly used to treat gastrointestinal conditions such as severe heartburn or acid reflux, and diabetic gastroparesis, a condition in which the stomach takes too long to empty its contents. It is indicated as a short-term therapy to be used for no more than 12 weeks. Studies have shown that long-term use of Reglan puts users at a 1-in-5 risk of developing tardive dyskinesia. The condition causes sufferers to develop symptoms such as lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers. The condition can be permanent, continuing even after the offending medication has been stopped.

Both lawsuits claim that the drug’s manufacturers didn’t adequately warn users that they were at risk for developing tardive dyskinesia. Both Keeper and Austin are seeking damages for medical expenses, physical pain and suffering, mental anguish, physical disfigurement, physical impairment, loss of earnings, loss of earning capacity, court costs, and interest.

Reglan and the generic metoclopramide now carry an FDA boxed warning about the risk of developing the movement disorder.

SOURCE: Reglan Side Effects › Two more lawsuits filed against makers of heartburn drug Reglan

Long-term use of antacids can disrupt the body chemistry. Continually reducing the amount of acid in the gastric system can, over time, cause it to produce more acid, resulting in another round of acid reflux, also known as acid rebound. But too little acid can be a problem as well. Stomach acid helps fight against substances that could harm the body and can leave the stomach more susceptible to infections.

Proton pump inhibitors, or PPIs, are the most powerful medications in the group of acid reflux treatments and overuse can cause a host of problems. For starters, the drugs can provoke underlying stomach disorders, including hyperplasia, an abnormal increase in the number of the organ cells. Another issue with PPIs surfaced just recently. Last month, the Food and Drug Administration (FDA) issued a warning to consumers and health care professionals that long term use of PPIs, both over-the-counter and prescription brands, may be linked to an increased risk of hip, wrist and spine fractures.

Perhaps the most alarming reaction to a type of acid reflux medication is a serious involuntary movement disorder known as Tardive Dyskinesia. The debilitating condition has been linked to the prescription heartburn drug metoclopramide, most commonly known by the brand name Reglan. The drug now carries a black box warning that long term use of Reglan can significantly increase one’s risk of developing the condition.

While these drugs can treat the bothersome symptoms of acid reflux, they are recommended only for short-term use. And unfortunately, once they are discontinued, as many as 80 percent of reflux-sufferers say their symptoms return within six months.

SOURCE: Reglan Side Effects › Acid reflux drugs provide temporary relief but can cause adverse reaction

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

“I recently met a lady visiting from Iran. She has been coughing for seven years. She had seen numerous physicians and had been tested extensively in Iran. She had no word for heartburn although she described, through a translator, ‘a volcano going off in my chest,’” writes Dr. Kurt Barrett in the Battle Creek (Michigan) Enquirer. While she sat in his office, Dr. Barrett gave the woman a dose of medicine to treat GERD. She said she felt an improvement. After a week she told Dr. Barrett her nagging cough was almost completely gone. She had used no cough syrups or inhalers, just the acid reflux medication.

Another uncommon symptom of GERD is hiccups, Dr. Barrett says. “You can prove it to yourself by trying over the counter Gaviscon (an antacid that foams/floats on top of the stomach contents) for immediate relief of hiccups.”

If heartburn symptoms persist or worsen, a medical professional should be consulted. Prescription medication, such as Reglan (metoclopramide) may be necessary. Be sure to discuss with your health care professional any risks or adverse events associated with your heartburn medication.

SOURCE: Reglan Side Effects › Less common symptoms of GERD can make diagnosis difficult

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

Melissa Kotlen Nagin

Reglan, or metoclopramide, is a medication approved by the Food and Drug Administration (FDA) for the treatment of heartburn and GERD. It is also prescribed, off label, to help stimulate lactation, “but it is definitely not as benign as Domperidone, which carries with it virtually NO side effects,” she says.

For one, Reglan can cause depression in mothers who are already more susceptible to depression because of hormone changes following childbirth. But Reglan also carries an FDA black box warning. Long-term use of Reglan greatly increases a woman’s risk of a serious involuntary movement disorder known as Tardive Dyskinesia. The condition can be debilitating and often does not go away, and often worsens, after the medication is discontinued.

Nagin’s advice? “If you are having milk supply issues, be sure to see a lactation consultant ASAP! The longer you wait, the more intense the process to get your supply back to where it should be.”

SOURCE: Reglan Side Effects › Lactation specialist warns against use of Reglan

Clinical trials are medical research studies involving people that seek to prevent disease, find treatments, diagnose diseases, or control symptoms. Trials on experimental drugs, such as the GERD study, aim to identify if the drug is safe, has side effects, works better than currently used treatments, and helps users feel better. Experimental drugs are not tested on people unless they show promising results in laboratory tests.

GERD is a chronic condition in which the liquid contents of the stomach regurgitate or back up into the esophagus. This liquid can inflame and irritate the lining of the esophagus, causing symptoms such as heartburn, sour taste in the back of the throat, a dry cough and interrupted sleep. If left untreated, it can also lead to esophageal cancer.

Treatments include diet changes and medication. While many drugs are available over-the-counter to treat heartburn, more potent prescription alternatives are limited. One common prescription treatment is Reglan (metoclopramide), however the drug carries an FDA black box warning of a serious, involuntary movement disorder known as Tardive Dyskinesia. For sufferers of GERD, identifying a safe and effective treatment could be life changing.

SOURCE: Reglan Side Effects › Participants needed for clinical trial on new GERD treatment

Most people dismiss the idea that they even have the acid reflux condition because they have none of the classic symptoms, but many sufferers of chronic cough may find relief when treating themselves for GERD.

One man wrote to popular medical question-and-answer columnist Dr. Gott about his dry, hacking cough that seemed to last the entire winter. His allergist gave him a thorough exam and offered numerous suggestions. Then he added, if all else fails, try an over-the-counter heartburn medication. The reader did, and his symptoms subsided.

“My hat is off to your allergist for thinking outside the box of his specialty and doing everything he could to help you,” Dr. Gott replied to the reader.

GERD is a chronic digestive disease that affects millions of Americans. It can be treated with lifestyle changes and over-the-counter treatments such as antacids and medications. However, some may need stronger medications available only by prescription, such as Reglan (metoclopramide). As with many drugs, there are risks to Reglan.

Last year, the Food and Drug Administration (FDA) placed a black box warning on Reglan after numerous reports of patients suffering from an involuntary movement disorder known as Tardive Dyskinesia.

For more information on diagnosing or treating GERD, contact your health care professional.

Sources:
Go Erie
Mayo Clinic

SOURCE: Reglan Side Effects › Chronic cough may be symptom of GERD

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?

Cancer of the esophagus is one of the 10 most common cancers, yet there is no good treatment for the disease. Most people who have been diagnosed with esophageal cancer also have a long history of heartburn. Heartburn occurs when toxic acid from the stomach splashes up into the esophagus. Over time, if left untreated, this constant bathing of stomach acid can damage tissue in the esophagus, a condition known as Barrett’s esophagus.

Barrett’s esophagus is generally treated with the same medications used to treat heartburn and GERD, including Reglan (metoclopramide).

The damaged tissue of Barrett’s esophagus cannot be reserved and if left untreated can lead to esophageal cancer. It is also impossible to remove the damaged tissue, which means the risk of cancer is always a threat.

However, Hans Clevers of the Hubrecht Institute had a hunch. He believed that since the cells in Barrett’s esophagus are very similar to the cells that line the colon, they might share some qualities that could lead to a better understanding in the treatment of Barrett’s esophagus. Researchers determined that the anti-Alzheimer’s drug DBZ, currently in clinical trials, had side effects that affected the lining of the lower colon. Using rat models, Clevers observed the effects of DBZ on Barrett’s esophagus tissue and found that the drug not only halted the growth of Barrett’s esophagus, in some cases it also completely destroyed the mutant tissue.

The treatment is far from human trials, but it still offers hope for a better treatment for Barrett’s esophagus and esophageal cancer in the future.

SOURCE: Reglan Side Effects › Alzheimer’s drug may treat Barrett’s esophagus, esophageal cancer

One popular choice in acid reflux treatment are pills known as Proton-Pump Inhibitors. “The dark side of Proton-Pump Inhibitors, because we’ve used so much of them for such a long period of time, is beginning to emerge,” says Dr. Henri Roca of LSU Health Sciences Center’s Family and Integrative Medicine during a interview with WWL-TV in New Orleans.

Proton-Pump Inhibitors are available both by prescription, such as Nexium, and over-the-counter, as Prevacid, Omeprazole and Prilosec. These drugs are recommended for use for seven or eight weeks. When someone takes them for 12 weeks or longer, problems arise.

When taken long term, Proton-Pump Inhibitors can inhibit the body from properly absorbing calcium, which puts long-term users at high risk for osteoporosis. It also interferes with the body’s defense mechanisms by clearing up bacteria that benefits the stomach and intestines, thus contributing to more gastrointestinal infections. And recently, the Food and Drug Administration (FDA) issued a warning about the combined use of the heart medication Plavix with Proton-Pump Inhibitors after tests showed that the Proton-Pump Inhibitors reduced the effectiveness of Plavix.

Another type of medication used to treat heartburn symptoms available only by prescription is Reglan (metoclopramide). Again, long-term (12 weeks or more) use of Reglan can have serious consequences. Early this year the FDA issued a black box warning on Reglan and other metoclopramide medications after numerous cases of a serious movement disorder known as Tardive Dyskinesia had been linked to use of Reglan. Tardive Dyskinesia can be debilitating and the symptoms may not stop even after the medication has been discontinued.

Doctors advise patients to talk with the doctors about their symptoms and any medications they may be taking. According to Dr. Roca, your symptoms may be caused by a number of ailments, and there may be safer and more effective ways to treat your heartburn symptoms.

SOURCE: Reglan Side Effects › Long term use of heartburn drugs can be dangerous

In a Phase IIb trial, Addex’s ADX10059 increased performed well in the treatment of gastroesophageal reflux disease (GERD). The four-week trial, which comprised 103 patients, showed ADX10059 significantly increased the number of symptom-free days for patients that took the drug compared to patients on a placebo. Patients involved in the trial had previously responded well to a group of drugs widely used for combating acid reflux called proton pump inhibitors, (PPIs).

The trial also showed that the medication was well tolerated among those in the trial. While adverse events were reported more often among those taking ADX10059 than the placebo group, the company reports that the vast majority of events were mild and none were described as severe. Participants who took ADX10059 also indicated a reduction in sleep disturbance compared to those in the placebo group, according to a patient questionnaire.

Addex says it has also completed patient recruitment for another trial of ADX10059, which combines the medication with PPIs. Results on that trial are expected in January 2010.

The results set Addex up to license the drug to a larger pharmaceutical company, which is anticipated sometime in 2010. Some estimates say a partnership could generate as much as $1.25 billion in annual sales.

Source: Addex Pharmaceuticals

SOURCE: Reglan Side Effects › New heartburn medication meets expectations in drug trial

GERD is a condition thought to be the result of an acid burn caused by stomach acid splashing up into the esophagus. It is often treated with medications that reduce stomach acid, such as Reglan (metoclopramide). But the new study squashes the “acid burn” belief. “Chemical injuries develop immediately,” the study’s leader, Dr. Stuart Spechler, told Reuters. “If you spill battery acid on your hand, you don’t have to wait a month to see the damage.”

Researchers say that the findings from the new study could change the way GERD is treated. “Currently, we treat GERD by giving medications to prevent the stomach from making acid,” said Dr. Rhonda Souza. “But if GERD is really an immune-mediated injury, maybe we should create medications that would prevent these cytokines from attracting inflammatory cells to the esophagus and starting the injury in the first place.”

An estimated 40 percent of Americans experience symptoms of GERD at some point, and as many as 20 percent suffer from persistent symptoms. If left untreated, GERD can cause esophageal cancer.

SOURCE: Reglan Side Effects › New study may lead to different treatments for GERD

Dr. David Carroll of Surgical Specialists of Jackson, Miss., offers a completely noninvasive procedure to treat GERD that requires no injection, cutting or penetration of the skin. It is called transoral incisionless fundoplication (TIF) surgery with the EsophyX device. Dr. Carroll says he has performed the procedure many times laparoscopically over the past 15 years, but the new EsophyX device allows him to perform the surgery using an endoscope inserted through the patients’ mouths.

“It developed over the last several years. The results are really good,” Dr. Carroll told the Clarion Ledger. He performed the first TIF with the EsophyX in Mississippi on 46-year-old Connie Braswell of Pearl, Miss. Braswell had treated her GERD symptoms for years with Nexium, but last year her symptoms worsened. “It got to the point where I was burping every day, all day long. It was very irritating,” she says.

Two gasterenterologists and two general practitioners tried her on various medications, including Reglan (metoclopramide), but nothing worked. She began restricting her diet, giving up dairy products, spicy food, coffee, and her beloved Dr. Pepper. She shed 28 pounds in the process, but she wasn’t happy. She missed the foods she used to enjoy.

Then Dr. Carroll told her about the new, noninvasive procedure using the EsophyX device, and it changed her life. “I prayed and prayed to get better and nothing else worked,” she says. “and this is working.”

Pictured are Dr. David Carroll, Dr. Jeffrey Glover and Dr. David Miller of Surgical Specialists of Jackson.

SOURCE: Reglan Side Effects › Non-surgical procedure offers hope to patients with GERD

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

The study, conducted by researchers from Copenhagen University, involved 120 healthy participants who took either an inactive placebo or 40 mg of the PPI drugs daily for three months. Each patient filled out a Gastrointestinal Symptom Rating Scale weekly to gauge symptoms. Researchers found that a greater percentage of people taking the PPI experienced at least one worrisome acid-related symptom during the treatment than those taking a placebo.

“We find it highly likely that the symptoms observed in this trial are caused by rebound acid hypersecretion and that this phenomenon is equally relevant in patients treated long term with PPIs. If rebound acid hypersecretion induces acid-related symptoms, this might lead to PPI dependency. Our results justify the speculation that PPI dependency could be one of the explanations for the rapidly and continuously increasing use of PPIs,” said Dr. Christian Reimer, the study’s lead author.

These findings show that safe treatment options for people suffering from GERD are limited. Earlier this year, Reglan (metoclopramide), another treatment for the condition, received a black box warning from the Food and Drug Administration (FDA) after numerous reports that people taking Reglan began to suffer suffer from a serious, involuntary movement disorder known as Tardive Dyskinesia. The black box warning advises that the medication not be taken for more than 12 weeks as the risk of contracting the disorder increases to about 20 percent among those taking the drug long term.

Experts advise suffers of GERD should consult with their physicians to find the safest treatment options.

SOURCE: Reglan Side Effects › Heartburn, GERD treatments linked to serious complications

Earlier this year the FDA placed a black box warning – the sternest warning it can require –on Reglan after reports of users of Reglan began suffering from a serious and debilitating involuntary movement disorder known as Tardive Dyskinesia. Those who suffer from the condition develop involuntary movements of the muscles, such as lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers.

Those who take Reglan for more than 12 weeks are at greater risk of developing Tardive Dyskinesia, thus the new labeling advises against long-term use except in rare cases where the benefit outweighs the risks.

Given the black box warning now on Reglan, sufferers of digestive problems may want to turn to old-fashioned, natural alternatives. For example, ginger root aides in digestion and licorice root soothes mucous membranes along the GI tract. Peppermint settles the stomach and aides in the production of saliva. And Rubarb works to rid excessive mucous in the intestines.

For more information, visit your local health food store. And always be sure to discuss any medication or diet changes with your health care provider.

Source: Examiner

SOURCE: Reglan Side Effects › Reglan users may want to consider natural remedies

While uncomfortable, both heartburn and GER are experienced at least weekly by some 20 percent of Americans. When GER symptoms occur more than twice a week, it is considered to be the more seriuos gastroesophageal reflux disease (GERD). GERD, which affects people of all ages, can eventually lead to more serious health problems.

Conditions such as a hiatal hernia or factors such as obesity, pregnancy and smoking can contribute to GERD. Foods can aggravate the condition, such as citrus fruits, chocolate, drinks with caffeine or alcohol, fatty and fried foods, garlic and onions, mint flavorings, spi8cy foods and tomato-based foods like spaghetti sauce, salsa, chili and pizza.

GERD and GER are often treated through lifestyle changes such as avoiding food triggers, losing weight, and not lying down for three hours after a meal. Medications can also be recommended or prescribed, such as antacids, foaming agents such as Gaviscon, H2blockers such as Tagament HB and Pepcid AC, proton pump inhibitors such as prilosec and Nexium, and prokinetics, such metoclopramide, known by the brand name Reglan.

Patients should discuss with their doctors which medication would work best for their condition. Some medications, such as Reglan (metoclopramide) have side effects such as fatigue, sleepiness, depression and anxiety that limit their usefulness. Reglan also has been linked to a serious physical condition known as Tardive Dyskinesia, which causes a person to develop jerking movements of their muscles in their bodies, in particular in their face and fingers. As always, any adverse reactions experienced while taking medication should be reported to your doctor.

Source: National Digestive Diseases Information Clearinghouse (NDDIC)

SOURCE: Reglan Side Effects › Heartburn, GER, GERD treatments should be discussed with doctor