Consumer Lawyers

FDA Warns Again on Painkiller Supplement – Reumofan Plus

In Product Recalls on August 27, 2012 at 8:48 pm

The FDA has issued a new warning against a Mexican “natural” dietary supplement marketed for pain relief due to unlabeled and potentially harmful drug ingredients.

Ongoing lab analysis of the supplements found that Reumofan Plus and Reumofan Plus Premium contain at least three unlabeled drug ingredients, including:

  • Dexamethasone: a corticosteroid that can cause withdrawal syndrome if discontinued after long periods of use or high doses
  • Diclofenac sodium: a nonsteroidal anti-inflammatory drug (NSAID) that can increase risk of serious cardiovascular and gastrointestinal events
  • Methocarbamol: a muscle relaxant that can cause sedation, dizziness, hypotension, and impaired mental and physical abilities

 

The agency issued an initial warning against the products in June, 2012, due to adverse event reports that included incidents of liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression. Since that warning was issued, the FDA has received reports of severe bleeding and withdrawal syndrome, the agency said in a statement issued Tuesday.

 

http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/34323

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