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

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

Drugs are available to curb the symptoms of acid reflux, even for the youngest infants. But they should be a last resort. Some of the medications routinely given to infants, such as Reglan (metoclopramide) can have serious side effects. Reglan has been associated with a number of drug interactions and can and may increase the risk of seizures in people who have seizures.

The first remedies to try should be natural ones. For example, finding relief for your little one may be as simple as changing the way your baby is fed. Decreasing volume and increasing the frequency of feedings can sometime remedy the problem. Bottle-fed babies can sometimes be given milk or formula thickened with a small amount rice cereal. Food allergies may also be the cause of reflux. The most common culprits are milk and soy proteins in formulas. Breast-feeding mothers should also take note of the foods they consume, as cow’s milk, soy, egg, and peanuts can cause their baby to experience reflux.

Because babies can’t adjust their position, parents should sit them upright when feeding and keep them upright after feeding. Placing a wedge – available at baby supply stores – under the baby’s mattress where the head goes also helps milk follow gravity and prevent reflux.

SOURCE: Reglan Side Effects › Infant reflux: Natural remedies should be tried before medical ones

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

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

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

“Our treatment induces collagen deposition. We create small thermal lesions which reform the lower esophageal sphincter and restore it to normal function,” Mederi CEO Will Rutan told Mass Device. “There are substantial, long-term data demonstrating high effectiveness rates and durability beyond four years, so it not only works, but it lasts.”

Curon Medical Inc., received clearance from the Food and Drug Administration (FDA) a decade ago to market the device. The company went bankrupt in 2006, paving the way for Mederi to acquire its assets. Mederi re-submitted the application for Stretta to the FDA and won clearance six months ago.

The product offers an alternative to patients who suffer from the severe acid reflux condition. GERD is often managed through diet and lifestyle changes but many require medication, such as Reglan (metoclopramide) in order to find relief. However, medications can have serious side effects.

Stretta’s target market is the 20 percent of GERD sufferers who cannot find relief through drugs or surgical intervention.

SOURCE: Reglan Side Effects › New device uses radiofrequency to offer relief to GERD sufferers

“The Food & Drug Administration’s well-known shortcomings in protecting consumers from dangerous prescription drugs have been illustrated in high-profile examples, like the recent scandal surrounding GlaxoSmithKline’s drug, Avandia, as well as Merck’s drug, Vioxx. These failures often stem from the relative weakness of the FDA as a regulatory body: overextended and underfunded, the FDA must largely rely on drug companies to police themselves,” Blizzard writes.

When it comes to generic drugs, Blizzard says the FDA’s current method is “badly flawed.” Here is why: When prescription drugs are approved by the FDA, they receive a patent, which stalls competition for a certain number of years in order for the company to recoup expenses incurred while developing the drug. During this time of free reign, the drug company must track and report adverse events and data to the FDA. Once the patent expires, competing manufacturers can market generic alternatives to the brand-name medication. These generic drug makers are required to report any adverse events or data to the FDA, but many fail to do so. In the end, it is the consumer who suffers.

For example, generic manufacturers of the acid reflux treatment Reglan (metoclopramide) failed to adequately monitor adverse events in patients taking the drug. The drug carries a risk of a serious involuntary movement disorder, Tardive Dyskinesia. Prolonged use – more than 12 weeks – raises one’s risk of developing the condition fivefold. It wasn’t until February 2009, after numerous people became ill, that the FDA issued a black box warning on Reglan and its generic alternatives.

“For too long, generic manufacturers have marketed potentially deadly products without regard for the long-term safety of their products,” Blizzard continues. “With the increased popularity of generics and the billions in additional profits that their manufacturers stand to make, this free ride must come to an end.”

SOURCE: Reglan Side Effects › Increase in availability of generic drugs may raise safety concerns

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

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

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

GERD “disrupts sleep, causes insomnia, and is associated with daytime impairment,” says Dr. Susan M. Harding with the University of Alabama at Birmingham, and may lead sufferers to seek treatment for sleep issues rather than for the condition that is causing the sleep disturbance.

The problem, says Dr. Anthony J. DiMario Jr., who leads a research study on the subject at Thomas Jefferson University, widely prescribed Ambien (zolpidem), which works to suppress nocturnal arousals to aide in restorative sleep, also helps people sleep through their symptoms of GERD. Those who sleep through their symptoms may forgo treatment to stop the symptoms and thus may suffer even worse complications.

GERD can be treated through lifestyle changes, such as raising the head of the bed so that the sufferer doesn’t sleep flat, eating smaller meals, and avoiding foods that promote reflux, such as chocolate, peppermint, alcohol and caffeinated drinks. Some medications, both prescription and OTC, are used to treat the condition, but some carry risks.

Reglan (metoclopramide) is a prescription medication approved in the treatment of GERD. A pro-motility drug that works by stimulating the muscles of the gastrointestingal tract including the esophagus, stomach, small intestines and colon, metoclopramide has been associated with a serious movement disorder known as Tardive Dyskinesia. The condition is debilitating and can continue even after treatment has been stopped.

Sources:
Science Daily
Reuters Health Stories

SOURCE: Reglan Side Effects › Sleep aids may hinder detection of nighttime GERD