FDA Tests Find Drugs in Pain 'Supplement'

SILVER SPRING, Md.FDA reissued its warning against Reumofan Plus and Reumofan Plus Premium, two products marketed as dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer and other conditions. FDA said they contain several potentially harmful active pharmaceutical ingredients that are not listed on the product labels.

FDA said it has received dozens of additional adverse event reports (AERs), 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 control, weight gain, swelling, leg cramps, withdrawal syndrome and adrenal suppression.

Lab tests showed Reumofan Plus contained dexamethasone,  a corticosteroid commonly used to treat inflammatory conditions; diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID); and methocarbamol, a muscle relaxant. A separate FDA lab analysis found Reumofan Plus Premium  contained diclofenac sodium and methocarbamol.

Dexamethasone can impair the bodys ability to fight infections and cause high blood sugar levels, bone and muscle injuries and psychiatric problems, according to FDA. Dexamethasone can also cause adrenal suppression when taken for a prolonged period of time or at high doses. Sudden discontinuation of corticosteroids after long-term use or use at high doses can result in a withdrawal syndrome that includes fatigue, nausea, low blood pressure, low blood sugar levels, fever, dizziness, and muscle and joint pain.

Diclofenac sodium may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation of the stomach and intestines.

Methocarbamol can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks, such as driving a motor vehicle or operating machinery.

 FDA encouraged consumers who are taking these products or who have recently stopped taking them to consult a health care professional. Consumers should not buy or start using these products, FDA warned.

Reumofan Plus and Reumofan Plus Premium are labeled in Spanish. However, versions of these products may also exist with English labeling. The products are manufactured in Mexico by Riger Naturals and sold in the United States in some retail outlets, at flea markets and on various popular Internet sites.

INSIDER's Take:

Products adulterated with prescription drugs taint the entire industry and fuel media reports such as the recent one on supplement "hazards" from Consumer Reports, and the one on product adulteration from the Chicago Tribune. The Consumer Report article said one of the supplement dangers is buying from Botanicas, stores that sell traditional medicinal plants often found in Hispanic neighborhoods, and flea markets.

While industry advocates such as Duffy MacKay, N.D., vice president, scientific and regulatory affairs, the Council for Responsible Nutrition (CRN) and John Shaw, executive director and CEO of the Natural Products Association (NPA), said most consumer don't go to flea markets to buy supplements, this case shows dangerous products are still being sold to consumers under the guise of supplements.

Because the products are manufactured in Mexico, the U.S. FDA cannot order a halt to operation, and the agency is not wide enough to have agents in every flea market or retail store that sells Reumofan Plus and Reumofan Plus Premium. Therefore, it's up to the industry to point out that these cases are rare and are not reflection of supplements as a whole. Reputable manufacturers can see this warning as an opportunity to remind consumers that they follow GMPs (good manufacturing practices) to ensure products aren't adulterated.