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Reglan Tardive Dyskinesia Warning by FDA

Metoclopramide 3d Image FDA MedWatch - 2009 Safety Alerts for Human Medical Products
Metoclopramide-Containing Drugs

The FDA announced today that the side effects from metoclopramide, ( a main ingrediant in many Reglan products) and a Gastrointestinal Medication, should be warned of a very serious disorder called tardive dyskinesia.

The FDA alerted healthcare officials that makers 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.

Metoclopramide usage of a long period of time has been linked to tardive dyskinesia, which can include involuntary and repetitive movements of the body. Even if you have not taken the drug for a while it sometimes can still occour.

The symptoms are often if not almost never reversible and there is no known treatment.

Metoclopramide is available in a variety of formulations including tablets, syrups and injections.

The Makers will be required to use a risk evaluation and mitigation strategy [REMS] to make sure that patients are provided with a medication guide that discusses this risk.

Makers include Baxter International Inc (BAX.N) and several generic drug companies.

More than 2 million Americans use the medicines to treat gastroesophageal reflux disease and other stomach ailments, the FDA said.

Products that commonly contain metoclopramide:

Reglan Tablets Reglan Oral Disintegrating Tablets Metoclopramide Oral Solution and Reglan Injection

According to Watergate Summer Whistle Blower,Mom and Nurse; “Many people take this med for Reflux and GI Ulcer symptoms and take for long periods of time.”

What is tardive dyskinesia?

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Reglan (Metoclopramide)

Reglan Tardive Dyskinesia Warning by FDA

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