Reglan
February 26, 2009 – The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.
Manufacturers will be required to implement a risk evaluation and mitigation strategy, or REMS, to ensure patients are provided with a medication guide that discusses this risk.
“The FDA wants patients and health care professionals to know about this risk so they can make informed decisions about treatment,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.”
Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment. The development of this condition is directly related to the length of time a patient is taking metoclopramide and the number of doses taken. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.
Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.
Metoclopramide works by speeding up the movement of the stomach muscles, thus increasing the rate at which the stomach empties into the intestines. It is used as a short-term treatment of gastroesophageal reflux disease in patients who have not responded to other therapies, and to treat diabetic gastroparesis (slowed emptying of the stomach’s contents into the intestines). It is recommended that treatment not exceed three months.
Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. More than two million Americans use these products.
Recently published analyses suggest 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 has 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.
Consumers and health care professionals are encouraged to report adverse events to the FDA’s MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md. 20852-9787, or online at: www.fda.gov/medwatch/report.htm
WASHINGTON (AP) — Federal health officials are adding their sternest warning to a heartburn drug that has been linked to muscle spasms.
The Food and Drug Administration said the drug, widely known as Reglan, has been shown to cause spasms and tics when used for long periods of time or at high doses. The problems include uncontrollable movement of the limbs, face and tongue, and are usually irreversible, even after patients stop taking the drug, according to the FDA’s warning.
The agency is requiring drugmakers to add a black box warning, the most serious type available, to their products.
Manufacturers also will be required to distribute medication safety guides to patients.
The drug was marketed by Wyeth for a number of years. However, the Madison, N.J.-based company sold the tablet form to Schwarz Pharma in 2001 and the injectable form to Baxter International in 2002. The drug also is marketed by a number of generic companies.
The drug’s current labeling already mentions risks of developing the spasms, called dyskinesia, but the agency’s action Thursday elevates the warning to the top of the label. Reglan, known generically as metoclopramide, comes in a variety forms, including injections and edible syrups. The drug works by speeding up the muscles used in digestion and relieving painful stomach acid reflux.
More than 2 million U.S. patients use the drugs, according to the FDA.
“The chronic use of metoclopramide therapy should be avoided in all but rare vases where the benefit is believed to outweigh the risk,” said Dr. Janet Woodcock, director of FDA’s drug center.
Regulators said patients who face the greatest risks include the elderly, especially women, and those who have been taking the drug for more than three months.
The agency based its decision on recently published studies suggesting metoclopramide is the leading cause of pharmaceutical-related movement disorders. One study showed that roughly 20 percent of patients who take the drug longer than three months develop dyskinesia.
Do I Have a Reglan (metoclopramide) Lawsuit?
If you or a loved one have taken Reglan or its generic metoclopramide and subsequently developed Tardive Dyskinesia, you should contact us immediately. You may be entitled to compensation fro your injuries and we can help.
Update: FDA Adds “Black Box Warning” to Metoclopramide-Containing Drugs Including Reglan
Reglan, a drug used to treat the symptoms of diabetic gastroparesis, which include vomiting, nausea, heartburn, feeling of indigestion, persistent fullness after meals, and appetite loss, manufactured by Baxter Healthcare, has been linked to a serious side effect including the following: Tardive Dyskinesia, a neurological disorder which causes involuntary movements of the tongue, mouth, face, lips and sometimes arms, trunk or legs.
What is Reglan?
Reglan (Metoclopramide hydrochloride), manufactured by Baxter Healthcare and approved by the FDA in 2004, is used to treat nausea, vomiting, and heartburn caused by gastric reflux. The FDA approved Reglan to be used by patients for a term of 4-12 weeks. Continuous treatment beyond 12 weeks is not recommended, however, 1/3 of patients are being prescribed the medication for 12 months or greater. The extended use of Reglan has led to the development of Tardive Dyskinesia in 27-29% of long term use patients.
Reglan Side Effects
Below is a list of the most common side effects of Reglan.
- Tardive Dyskinesia
- Involuntary movements of the tongue, mouth, face, lips and sometimes arms, trunk or legs
- Neuroleptic Malignant Syndrome
- Death
Reglan Lawsuit - Your Legal Rights
If you or somebody you know has developed Tardive Dyskinesia, Neuroleptic Malignant Syndrome or is suffering from Reglan side effects, you should contact one our Reglan attorneys as soon as possible. Regardless of your situation, you are sure to have questions. The only way to get your questions answered is to learn your legal rights and that is where our Reglan lawyers come in.
An experienced Mass Tort law firm can answer your questions and provide you with a free case evaluation regarding the potential to seek financial recovery through litigation. While we understand that a financial recovery will not bring back a loved one or compensate for a lifelong disability, we also urge you to exercise your right to seek legal counsel regarding your potential Reglan lawsuit.
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