Hidden drug ingredients that can cause serious and potentially fatal side effects have been found in Reumofan Plus and Reumofan Plus Premium, products marketed as "natural" dietary supplements for treating arthritis, muscle pain or other conditions, the Food and Drug Administration warned.
Consumers should not buy or start using these products. People who have been taking, or recently stopped taking, Reumofan Plus or Reumofan Plus Premium should immediately consult a health care professional, said the FDA.
Ongoing FDA lab tests of Reumofan Plus found that it contained the following prescription drug ingredients:
• dexamethasone, a corticosteroid that can increase the risk of infection and cause changes in blood sugar levels and blood pressure, and damage to bones, psychiatric problems and adrenal suppression.
• diclofenac sodium, a non-steroidal anti-inflammatory drug that may increase the risk of heart attack and stroke, as well as serious gastrointestinal side effects including bleeding, ulceration, and rarely fatal perforation of the stomach and intestines.
• methocarbamol, a muscle relaxant that can cause sedation, dizziness and low blood pressure, and impair mental or physical abilities.
A separate FDA lab analysis of Reumofan Plus Premium found that it contained both diclofenac sodium and methocarbamol.
The FDA's latest safety alert said the agency has received dozens of adverse event reports, including death and stroke, associated with the use of Reumofan Plus since the agency issued its first warning about the product on June 1, 2012. Other reports include liver injury, severe bleeding, sudden worsening of glucose (sugar) control, weight gain, swelling, leg cramps and withdrawal syndrome, and adrenal suppression.
Any of the drug ingredients found in Reumofan Plus or Reumofan Plus Premium can also interact with other medications a consumer may be taking and result in serious health consequences, the FDA warned.
"The presence of potentially dangerous prescription drugs in these two products reflect the uncertainty implicit in the purchase of dietary supplements," says Marvin M. Lipman, M.D., chief medical adviser for Consumer Reports. "In the supplement market, there is no assurance that what you're buying is what you're getting."
Bottom line: Don't assume "natural" means safe, or even natural. See our new report, 10 Surprising Dangers of Vitamins and Supplements.
FDA issues new safety alert on Reumofan Plus and Reumofan Plus Premium (FDA Press Announcement)
Reumofan Products Pose Risk to Consumers (FDA Consumer Update)