Mandatory Boxed Warning Added to Metoclopramide Label Regarding Irreversible Side Effects
Source: The Food and Drug Administration
Metoclopramide, a drug used to treat gastrointestinal disorders, has a new health risk warning for long-term or high-dose users. Chronic use of this drug has been directly connected to an untreatable involuntary and repetitive movement of the body (tardive dyskinesia), even after the drug is no longer taken.
Metoclopramide-containing products include:
- Reglan Tablets
- Reglan Oral Disintegrating Tablets
- Reglan Injection
- Metoclopramide Oral Solution
Patients taking this medicine should contact their health professional to assess the necessity of this prescription and evaluate other alternatives.
Manufacturers will be required to provide patients with a comprehensive medication guide that discusses this risk.
Read the entire MedWatch 2009 safety summary, including a link to the FDA News Release, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Metoclopramide
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