FDA Alert About a Dietary Supplement for Pain

The U.S. Food and Drug Administration has issued an alert related to patients using Reumofan Plus, who may be seen by rheumatologists in their clinical practices. This product is an unapproved drug, but it is being sold as a dietary supplement for pain and contains three undeclared prescription drugs, present at levels at or above the levels in approved FDA drugs that contain the corresponding active ingredient. Reumofan use has been associated with serious adverse events, including several deaths, in reports received by FDA since the initial alert on this product was issued on June 1, 2012.

More details are provided on the FDA website, which describes the products affected and provides background information and recommendations for action by consumers and providers. Because the affected audience is known to include U.S. consumers who are primary Spanish language speakers, the FDA has also provided a news release in Spanish.

• FDA MedWatch safety alert
• FDA consumer update
• FDA news release (English)
• FDA news release (Spanish)
• Consumer Q&A's

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