The U.S. Food and Drug Administration has issued an updated alert that Reumofan Plus and Reumofan Plus Premium contain undeclared prescription drug ingredients that have impacted public safety.

The agency announced it has received reports of “fatalities, stroke, severe bleeding in the gastrointestinal tract, dizziness, insomnia, high blood sugar levels and problems with liver and kidney functions,as well as corticosteroid withdrawal syndrome,” in the two months since initially announcing the recall on the product in June.

Reumofan Plus PREMIUM 003

Reumofan Plus PREMIUM 003 on Flickr
by The U.S. Food and Drug Administration via Flickr.

The U.S. Food and Drug Administration has issued an updated alert that Reumofan Plus and Reumofan Plus Premium contain undeclared prescription drug ingredients that have impacted public safety.

The agency announced it has received reports of “fatalities, stroke, severe bleeding in the gastrointestinal tract, dizziness, insomnia, high blood sugar levels and problems with liver and kidney functions,as well as corticosteroid withdrawal syndrome,” in the two months since initially announcing the recall on the product in June.

Reumofan Plus is marketed as a natural dietary supplement for pain relief.  FDA laboratory analysis found that it contains Diclofenac Sodium, an prescription non-steroidal anti-inflammatory drug (NSAID) and Methocarbomal, a prescription muscle relaxant.  Additionally, the Mexican Ministry of Health discovered at least one lot that contained the corticosteroid dexamethasone, an anti-inflammatory and immune system suppressant.

Side effects from the prescription NSAID include increased risk of cardiovascular events such as heart attack and stroke, gastrointestinal bleeding, ulceration and fatal perforation of the stomach and intestines.  Methocarbomal can cause sedation, dizziness, low blood pressure and ability impairment.

In June, the FDA issued a warning that they had “received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression.”

Reuomofan Plus is manufactured in Mexico by Rigers Naturals and sold at retail outlets as well as on the internet.