Reglan is a brand name drug first developed by Wyeth, bought by Pfizer in 2009, used for the treatment of gastrointestinal and esophageal problems. The drug’s generic name is metoclopramide, and it is now available as a generic and under several different brand names made by different drug companies. It is well tolerated by most users, with some possible side effects, and is listed by the World Health Organization as an essential medication.
On the other hand, Reglan has been known to cause some very serious health problems in some users. It is one of the most common causes of movement disorders triggered by medication. Specifically, it is known to cause a condition called tardive dyskinesia in some users. This is a serious condition that causes involuntary muscle movements, which if not treated early can be permanent or even become worse. A number of lawsuits have been filed against various drug makers by people who have suffered from this condition after using metoclopramide.
Uses for Reglan
Metoclopramide is used to treat several symptoms and conditions that affect the esophagus and the gastrointestinal system. It can be prescribed to relieve heartburn and to help heal the sores and ulcers that form in the esophagus of someone who has GERD, gastroesophageal reflux disease. For these purposes, Reglan is usually used after other treatments have proven unsuccessful.
In some people with diabetes, Reglan can be prescribed to help relieve the symptoms of a stomach that empties to slowly. Symptoms that Reglan can help include vomiting, heartburn, a loss of appetite, nausea, and a feeling of fullness or being too full, even hours after eating.
Metoclopramide works generally as an antiemetic, a drug that relives nausea and vomiting. It may be given to patients who have certain conditions that cause these symptoms, like radiation sickness, cancer with chemotherapy treatment, uremia, severe infections, and migraines. Pregnant women experiencing severe nausea and vomiting, called hyperemesis gravidarum, may also be given Reglan. Veterinarians use metoclopramide to treat nausea and vomiting in animals as well.
How it Works
Metoclopramide is a drug that belongs to a class called prokinetic agents. These are drugs that bind at certain receptors in the body and cause the intestines to move food and other substances through more quickly. Metoclopramide increases the cycles of contraction and relaxation in the stomach and small intestines that cause food to pass through the gastrointestinal system.
Metoclopramide is an important medication that helps many people, but it also has the potential to cause a lot of side effects. The most common side effects are not serious unless they are severe or persist. These include restlessness, sleepiness, dizziness, fatigue, confusion, headaches, and difficulty sleeping.
Other possible side effects include frequent urination or an inability to control urination, nausea, vomiting, and diarrhea, sexual dysfunction, breast enlargement, and missed periods. Some people may also have an allergic reaction to Reglan, which may be serious. If you take this medication and experience hives, itchy skin, swelling in the face or throat, and difficulty breathing, you should seek emergency medical attention.
In 2009 the U.S. Food and Drug Administration (FDA) issued a warning about metoclopramide and a possible side effect that can be serious and long-lasting. The FDA required that all companies selling Reglan or any other branded or generic version of metoclopramide add a black box warning about this condition called tardive dyskinesia. The risk is greater for anyone taking high doses of the medication or using it over a long-term, for older women, and for anyone with diabetes. With the warning comes the recommendation that no one should take Reglan for longer than twelve weeks.
Tardive dyskinesia is a condition triggered by medications that causes involuntary muscle movements and spasms anywhere in the body, but most commonly in the lower half of the face. Several different types of antipsychotic medications, mostly used to treat schizophrenia, trigger the condition, but so do other drugs, including metoclopramide.
Symptoms of tardive dyskinesia include movements that you cannot control. Most of these are in the face and include sticking out the tongue, blinking, chewing, smacking lips, puffing out cheeks, grunting, or frowning. The condition may also affect the limbs and may cause you to wiggle fingers, flap arms, sway, tap your feet, or thrust your pelvis.
Doctors prescribing Reglan and patients taking it are warned to consider the benefits and risks of the medication versus the possibility of developing tardive dyskinesia. Patients are also encouraged to watch for signs of the condition. When the signs are spotted early and use of the drug is discontinued, the involuntary movements may stop. If it goes on too long without a diagnosis or without discontinuing the medication, the condition may become permanent and may even worsen over time. It can be treated with certain other drugs, including botulinum toxin, but there is no cure for tardive dyskinesia if it is caught too late.
Another possible adverse effect of taking Reglan is depression and suicidal thoughts. This is a side effect that should not be ignored and can be serious. If you take metoclopramide, you should be aware and report to your doctor if you start to feel depressed or think about hurting or killing yourself. It is also important to watch for these signs in someone else taking the medication.
Neuroleptic Malignant Syndrome
Although rare, neuroleptic malignant syndrome, or NMS, has been reported with use of Reglan. This is a very serious condition that can be fatal without treatment. Symptoms of the condition include stiff muscles, a fast or irregular heartbeat, heavy sweating, a high fever, and difficulty thinking. As with tardive dyskinesia, this condition is medication-triggered. Treatment begins with discontinuing use of metoclopramide, followed by medical treatment of the symptoms.
Many lawsuits have been filed against Wyeth, Pfizer, and other companies that make and market metoclopramide, mostly because of the risk of developing tardive dyskinesia. Studies were published decades ago showing a link between random muscle spasms and metoclopramide, and yet the FDA black box warning did not come out until 2009. This means that the truth about the risks of developing this serious and life-altering condition was kept from most patients for 30 years or more.
Even with thousands of cases against the drug companies being filed, no class action suit has been consolidated. This is because there are so many manufacturers of metoclopramide. The individual suits claim that all of these companies failed to disclose risks on warning labels, failed to adequately warn doctors and patients, failed to communicate all risks to the FDA, and did not do an adequate job of testing metoclopramide use over the long-term in clinical studies.
Plaintiffs have suffered long-term damage from developing tardive dyskinesia. Living with involuntary muscle spasms, especially in the face is akin to being disfigured. The condition can also make other diseases, like Parkinson’s disease, worse. Those people suing over metoclopramide are requesting compensation because of lost wages, lost jobs, medical expenses, and the loss of a certain quality of life.
In 2013, an important step for plaintiffs was made in Alabama courts. There the state’s Supreme Court ruled that a patient who had taken a generic form of metoclopramide could sue both the generic drug maker and the companies—Wyeth and Pfizer—that developed the original brand name drug, Reglan. Although the decision applies in Alabama only, it is expected to have nationwide consequences and could help more plaintiffs get justice and compensation.