Reglan is a drug commonly prescribed to treat gastric reflux and diabetic gastric distress. Reglan is a dopamine agonist and inhibits the central and peripheral effects of apomorphine, induces release of prolactin and causes a transient increase in circulating aldosterone levels. Reglan is manufactured in tablet form by Schwarz Parma, Inc. and in an injectable form by Baxter Pharmaceuticals. Reglan has been on the market since the early 1980s and, therefore, has gone generic and is available under several other trade names as well as its chemical name Metoclopramide.
The drug has been indicated for short-term therapy (four to 12 weeks) since at least 2004. The label has also warned that tardive dyskinesia may develop in patients treated with Reglan and that risk of developing the condition and the likelihood that it will become irreversible are believed to increase with duration of treatment and cumulative dose. Tardive dyskinesia is a neurologic disorder characterized by involuntary, repetitive movements of the extremities, as well as grimacing, rapid blinking and impaired movement of the fingers.
While the manufacturer had previously warned of tardive dyskinesia as a possible side effect, recent published analysis showed that Reglan has surpassed haloperidol as the most common cause of drug-induced movement disorders. You may recall, Eli Lilly created a blockbuster drug, Zyprexa, based on its claim that its drug had a lower incidence of tardive dyskinesia than haloperidol. The studies, along with adverse event reports, also reveal that patients in large numbers (as many as 30%) are being prescribed this drug for longer than 90 days. Most reports of tardive dyskinesia have been in association with greater than 12 weeks exposure to Reglan. The manufacturer had previously represented the incidence of tardive dyskinesia to be about 0.2%. For patients on the drug more than 12 weeks, it appears the rate may be exponentially higher.
On May 9, 2009, the FDA, pursuant to its new powers under the amended Food, Drug and Cosmetic Act, ordered the manufacturers to add a Black Boxed Warning, the highest level of warning, and to submit a proposed Medication Guide for Reglan to explain these risks to patients. This is a very aggressive and rarely-seen pharmacovigiliance enforcement action by the FDA. It would not be surprising to see this drug removed from the market this year. If you need additional information contact Russ Abney at 800-898-2034 or by email at Russ.Abney@beasleyallen.com.
Source: Risk Evaluation and Mitigation Strategies letter from Joyce Korvick, M.D., M.P.H., at the FDA to all manufacturers of Metoclopramide.
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