Following reports of bleeding, strokes and death, the FDA is warning consumers that Reumofan dietary supplements contain undeclared drugs.
Reumofan Plus and Reumofan Plus Premium contain the active ingredients in Voltaren, Decadron, and Robaxin, the FDA warned on August 21. As a result of this drug combo, side effects of Reumofan could place users at risk of severe injury or death, according to the health regulators.
It is illegal for products billed as dietary supplements, which are generally immune from federal regulation, to contain FDA-controlled medications.
Reumofan is billed as a treatment for a variety of ailments, including arthritis, bone cancer, osteoporosis, muscle pain and other problems. However, the ingredients list does not name the FDA-controlled drugs the agency found.
The FDA first warned of a possible problem earlier this summer, after the agency received dozens of adverse event reports, including deaths, strokes, gastrointestinal bleeding problems liver injury, worsening glucose control, and other health effects.
In fact, one of the unlisted drugs is so powerful that the FDA is advising people who are taking Reumofan products to go see their doctor before they stop using it. Decadron is a powerful corticosteroid that must be discontinued under medical supervision due to the risk of withdrawal syndrome.
The other two drugs, Voltaren and Robaxin, are a non-steroidal anti-inflammatory drug (NSAID) and muscle relaxant, respectively. Voltarin can increase the risk of heart attack and stroke, while Robaxin could cause dizziness, low blood pressure and can impair mental and physical activity.
The drugs were found in an FDA laboratory analysis.
Reumofan is manufactured by Riger Naturals in Mexico. The labels are in Spanish, but the FDA warns there may be English-language copies on the market as well. It has been sold online, at flea markets and by some retailers in the U.S. The Mexican Ministry of Health has ordered the company to conduct a Reumofan recall at the FDA’s behest.
Because it was billed as a natural dietary supplement, there was no safety review of Reumofan before it was sold to U.S. consumers. However, once the FDA finds that there are regulated drugs in a dietary supplement, it can step in and regulate the product.
The FDA requests that anyone who has experienced health problems after taking Reumofan should contact MedWatch, the FDA’s adverse event reporting program either online or by calling (800) 332-1088.