Reglan Side Effects Cause Tardive Dyskinesia. Are you among the Reglan users who have experienced involuntary and repetitive movements of the body? Chronic use of Reglan has been associated with a movement disorder called tardive dyskinesia, which can continue to affect Reglan users even after the drug is discontinued. In early 2009, the U.S. Food & Drug Administration (FDA) ordered the maker of Reglan to add a boxed warning about this risk to its label.
Our firm is already representing victims of Reglan induced tardive dyskinesia, and we intend to make sure Wyeth is held accountable for the injuries this drug has caused.
Reglan lawsuits allege that Wyeth knew of a widespread tendency among physicians to mis-prescribe Reglan for long periods of time even though the medication is only approved for 12 months of use.
If you or someone you love has taken Reglan and have suffered from the involuntary and repetitive movements typical of tardive dyskinesia, our Reglan injury lawyers want to hear from you. Please contact us today to protect your legal rights.
Reglan, also known as metoclopramide, is used short-term to treat heartburn caused by gastroesophageal reflux in people who have used other medications without relief of symptoms. Reglan is also used to treat slow gastric emptying in people with diabetes (also called diabetic gastroparesis), which can cause nausea, vomiting, heartburn, loss of appetite, and a feeling of fullness after meals.
Metoclopramide is also marketed under the names Octamide, Maxolon, Degan, Maxeran, Primperan, and Pylomid. These drugs work by speeding up the movement of the stomach muscles, thus increasing the rate at which the stomach empties into the intestines. Reglan and other metoclopramide products are available in a number of formulations including tablets, syrups and injections. Reglan and other forms of metoclopramide are taken by an estimated two million Americans
Reglan is only approved for short-term use (4-12 weeks). However, it has become apparent that many patients are prescribed the drug for longer periods of time. For some patients, the misuse of Reglan has had devastating health consequences.
In February 2009, the FDA mandated that the makers of Reglan and other metoclopramide products add a boxed warning to their labels regarding the risk of tardive dyskinesia associated with chronic, long-term use. The FDA’s mandate followed the publication of analyses that suggested that metoclopramide is the most common cause of drug-induced movement disorders.
Another analysis of study data by the FDA showed that about 20 percent of patients in that study who used metoclopramide took it for longer than three months. The FDA said it had also become aware of continued spontaneous reports of tardive dyskinesia in patients who used metoclopramide, the majority of whom had taken the drug for more than three months.
In addition to the boxed warning, the FDA also required the makers of Reglan and other metoclopramide products to develop a risk evaluation and mitigation strategy, or REMS. The REMS is designed to weigh the risks and benefits of using these drugs and to provide additional warning to users of these products.
The term tardive dyskinesia has been in use since 1964. This horrible disorder is characterized by repetitive, involuntary movements. Tardive dyskinesia can plague victims long after they stop taking Reglan.
Symptoms of tardive dyskinesia may include:
- Involuntary/ repetitive movements of the extremities
- Facial tics
- Lip smacking, pursing and puckering
- Face Grimacing
- Tongue protrusion
- Rapid eye movements or blinking
- Impaired movement of the fingers.
- Restless Leg Syndrome (RLS)
There is no treatment or cure for tardive dyskinesia. While stopping Reglan may relieve some symptoms in some patients, in other patients the symptoms of tardive dyskinesia actually worsen when Reglan is discontinued.
Reglan and Abnormal Involuntary Movements (Extrapyramidal Symptoms) in Children
Reglan has been linked to abnormal involuntary movements, or extrapyramidal symptoms, in children. In January 2015, Health Canada issued a warning letter to health care professionals in collaboration with Sandoz Canada Inc., Apotex Inc., Omega Laboratories, and the Pendopharm Division of Pharmascience Inc. warning about this side effect. Two new contraindications were also added to the drug’s safety information.
A safety review conducted by Health Canada found that “Extrapyramidal symptoms may occur in children receiving the daily recommended dose of metoclopramide that should not exceed 0.5 mg/kg.” The review, which analyzed the neurological effects of the drug, also resulted in two new contraindications.
The agency stated that Reglan should not be used in children younger than one year because the risks associated with the medication outweigh the benefits; the drug should also not be used in children older than one year of age unless the expected benefits clearly outweigh the risks. “The Canadian Product Monographs for metoclopramide drugs were revised recently to include the new contraindication and restrictions on the use of metoclopramide in children.” the letter stated.
Health Canada urged healthcare professionals and consumers to report any adverse events related to the use of Reglan, and stated that “Any case of serious neurological adverse events or other serious or unexpected adverse reactions in patients receiving APO-Metoclop, Metoclopramide Hydrochloride Injection, Metoclopramide Omega, or METONIATM should be reported to Apotex Inc., Sandoz Canada Inc., Omega Laboratories Limited, and the Pendopharm Division of Pharmascience Inc., respectively, or Health Canada.”