Metoclopramide (Reglan) Drug Injury
Recently, Food and Drug Administration (FDA) officials found that metoclopramide, a drug used to treat gastrointestinal disorders under the trade name Reglan, posed significant risk of neurological injury. In June 2009, the FDA ordered manufacturers of metoclopramide to include the FDA's most serious advisory, a black box warning.
Black box warnings are reserved for pharmaceuticals that pose significant risk and can be a precursor to market recall. In the case of metoclopramide, FDA review discovered that chronic metoclopramide (Reglan) therapy significantly increased the risks of tardive dyskinesia, an often irreversible condition with Parkinson's-like symptoms. Reglan, manufactured by Schwarz Pharma, comes many forms, not limited to the following metoclopramide products on the market
- Reglan Tablets
- Reglan Oral Disintegrating Tablets
- Reglan Injection.
Long-term use of any of these metoclopramide products may lead to neurological injury.
FDA officials at the FDA's Center for Drug Evaluation and Research state that chronic use of metoclopramide therapy should be avoided in all but rare cases and have ordered manufacturers to implement a risk evaluation and mitigation strategy (REMS) to ensure at-risk patients are provided information that detailing the risk of tardive dyskinesia from chronic metoclopramide treatment.
Higgins Firm is now actively accepting Tennessee Reglan injury cases and select cases in Georgia, Kentucky, and neighboring states. For a free consultation, call 1.800.705.2121. Or take legal action by completing Higgins Firm's Reglan injury form.