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Reglan:
Side Effects And Problems Of Reglan

Reglan Drug:
Reglan - FDA Issues A Black Box Warning

Reglan Lawsuits:
Reglan Lawsuits And Injury Claims

Food & Drug Administration Issues Black Box Warning for Reglan Use

The U.S Food and Drug Administration (FDA) announced on February 26, 2009, that makers of metroclopramide, marketed under Reglan Tablets, Reglan Oral Disintegrating Tablets, Reglan Injection and Metoclopramide Oral Solution, must add a ‘black box warning’ to their drug labels warning of the risk of the drug’s long-term and/or high-dose use. A black box warning is the FDA’s strongest warning. Although current product labels already warn patients and physicians of the risk of tardive dyskinesia and other dangerous side effects that can occur when taking metroclopramide-containing drugs, the addition of a ‘black box warning’ further advises doctors to be even more alert as to prescribing and side-effect protocols. Long-term/high-dose use of the drug has been associated with tardive dyskinesia, a syndrome which includes involuntary and repetitive movements of one’s body, even after the drug has been discontinued. The elderly, especially women, are at an increased risk for developing this often devastating syndrome.

FDA Reports

Recently published analyses show that metoclopramide is the most common cause of drug-induced movement disorders. Data by the FDA showed that about 20% 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.

According to Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, “The FDA wants patients and health care professionals to know about this risk so they can make informed decisions about treatment. The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.”

The FDA approved Reglan in 1985 for the short-term treatment (between 4 and 12 weeks) of severe nausea and/or vomiting only after other treatment methods had failed.

Adverse Symptoms Associated with Metroclopramide Use

• Tardive dyskinesia, perhaps the most common and serious side effect associated with Reglan use, is characterized by involuntary and repetitive movements of the extremities and face and may include rapid eye movements and blinking, puckering and pursing of the lips, grimacing, lip smacking, tongue protrusion and impaired movement of the fingers. These symptoms are often irreversible although, in some patients, symptoms may lessen or even disappear after metoclopamide is stopped. These socially-unacceptable movements have forced many victims to stay in their homes for fear of being mocked. There is no known treatment of tardive dyskinesia. In patients who have taken Reglan for longer than 12 weeks, about 20% developed some form of this syndrome.
• Dystonia, another side effect connected to Reglan use, is a neurological movement disorder in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures. This is seen more often in children and young adults.
• Raised prolactin levels; this drug should be used with caution in patients with previously diagnosed breast cancer.
Epilepsy
Depression
Hypertension
Persistent vomiting
Parkinson’s disease
Renal insufficiency
Drowsiness, fatigue, lethargy

Metroclopramide is counterindicated during the first trimester of pregnancies and should only be used in extreme cases in lactating patients.

Reglan Drug Information - How Reglan Works

Metoclopramide works by speeding up the movement of the stomach muscles, increasing the rate that 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. Metroclopramide, which is used by over two million Americans, is used to treat serious gastrointestinal problems, often associated with cancer chemotherapy treatments, migraine headaches and other causes of severe and chronic of nausea and vomiting.

Manufacturers will be required to implement a risk evaluation and mitigation strategy (REMS) to ensure patients are provided with a medication guide that discusses this risk. Reglan is manufactured by Baxter Healthcare Corporation; generic versions are made by Wyeth, Pliva, Schwarz Pharma, and Teva Pharmaceuticals.

If you or a family member has been negatively affected by Reglan, contact us now at 800-xxx-xxxx or fill out the form on this page. Our experienced attorneys will help you get the compensation that YOU deserve.