Reglan Medication and Tardive Dyskinesia

by Steve Fields on October 23rd, 2009

Reglan (metoclopramide) is used as a short-term treatment of certain conditions such as Gastroesophageal Reflux Disease (commonly referred to as GERD, acid reflux disease or persistent heartburn) and Gastroparisis (a disorder seen in diabetic patients where the stomach takes too long to empty). Metoclopramide belongs to a class of drugs known as dopamine receptor blockers. Metoclopramide works by increasing stomach emptying and movement in the upper intestines. Reglan tardive dyskinesia problems continue to affect many patients who have used these drugs for over three months.

Metoclopramide is available in a variety of forms including tablets, syrups and injections. Products that contain metoclopramide include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution and Reglan Injection. Over 2 million Americans have been prescribed Reglan.

Common side effects of Reglan (metoclopramide) use include decreased energy; diarrhea; difficulty sleeping; dizziness; drowsiness; headache; nausea; restlessness; or tiredness. More severe side effects include allergic reactions; abnormal thinking or confusion; dark urine; decreased coordination; decreased sexual ability; fever or hallucinations; increased sweating; involuntary muscle movements, twitching or tremors; irregular heartbeat; loss of bladder control; mental or mood changes such as depression, anxiety, agitation, seizures; severe or persistent dizziness, headaches, or trouble sleeping; severe or persistent restlessness; shortness of breath; stiff muscles; sudden weight gain; suicidal thoughts or actions; swelling of the arms, legs, or feet; vision changes; yellowing of the skin or eyes. Chronic, long-term and/or high dose use of metoclopramide has been linked to serious drug induced movement disorders such as tardive dyskinesia.

Tardive dyskinesia is a neurological syndrome typically characterized by repetitive, involuntary movements of the face, tongue, lips, mouth, or jaw, and sometimes by involuntary movements of the arms, legs, fingers and trunk. Movements may include facial grimacing, tongue protrusion, lip smacking or puckering, rapid eye movements or uncontrolled blinking, and rapid and involuntary movements of the arms, legs, or fingers. Treatment of tardive dyskinesia includes stopping or reducing the use of Reglan (metoclopramide). However, the symptoms of tardive dyskinesia may continue long after discontinuation of Reglan (metoclopramide) and there is no known treatment. In some patients, symptoms may lessen or disappear after Reglan (metoclopramide) treatment has stopped. The majority of patients who have developed tardive dyskinesia have been treated with Reglan (metoclopramide) for more than three months.

The U.S. Food and Drug Administration (FDA) announced in February 2009 that manufacturers of metoclopramide are required to add a black box warning to their packaging about the risk of tardive dyskinesia associated with its long-term and/or high-dose use. In addition to the black box warning, the FDA is requiring manufacturers to implement a risk evaluation and mitigation strategy so that patients are provided with a medication guide that explains the risk of tardive dyskinesia with chronic metoclopramide treatment. This strategy will help patients and health care professionals to make informed decisions about any treatment and the severe risks associated with long-term and/or high dose use of metoclopramide. Please contact us for a free consultation from a Reglan lawyer representing patients and families nationwide.