Reumofan Plus Recall Issued After Liver Injury, Kidney Damage Reports

Federal drug regulators are warning that the dietary supplement Reumofan Plus contains undeclared drugs that could cause injury or death, and they have ordered that the drug be pulled from store shelves. 

A Reumofan Plus recall was announced by the FDA on June 1, after it was discovered that the supplement has undeclared pharmaceutical ingredients, including the active medications contained in the painkiller Voltaren and the muscle relaxant Robaxin. The product is promoted as an arthritis treatment and as a treatment for muscle pain, osteoporosis and bone cancer.

FDA officials say the agency has received multiple reports of adverse events linked to Reumofan Plus, including liver injury, weight gain, worsening glucose control, leg cramps, swelling and kidney problems.

The agency’s analysis of the drug detected the active ingredients diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID) used in Voltaren, and methocarbamol, a muscle relaxant used in Robaxin. Mexican health authorities said that one lot they investigated also contained the corticosteroid dexamethasone.

Diclofenac sodium may increase the risk of heart attacks and strokes, and can cause serious gastrointestinal problems such as bleeding, ulcers and potentially fatal perforations of the stomach and intestines. Methocarbamol has been linked to low blood pressure, dizziness and impaired mental and physical capabilities. Users of Reumofan Plus would have been unaware of these drugs and their side effects, which could have been worsened when combined with other medications the consumers may have been taking.

Reumofan Plus was manufactured in Mexico by Riger Naturals and was sold through retail outlets, the internet and at flea markets. The Mexican Ministry of Health has ordered the company to issue a recall as well.

Dietary supplements do not fall under the purview of the FDA as long as they contain no regulated drugs and as long as they do not claim to cure a medical condition. However, when controlled drugs are found in a dietary supplement it is considered an unadulterated drug and then falls under the FDA’s regulatory umbrella.

The FDA urges health care professionals to inquire about the use of dietary supplements when patients have unexplained symptoms that resemble adverse drug reactions, like NSAID toxicity, liver problems and depression.