Aug. 23, 2012 -- Consumers searching for a miracle cure for the aches and pains of arthritis should beware: The FDA has issued a new warning about the potential health risks of Reumofan and Reumofan Plus, two products marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions.
The FDA said it found both supplements contain several potentially dangerous ingredients that are not listed on the label. Since the first warning was issued in June, consumers have begun to speak up.
"The FDA has received dozens of additional adverse event reports, including death and stroke, associated with the use of Reumofan Plus," said Sarah Clark-Lynn, an FDA spokesperson. "Other reports include liver injury, severe bleeding, sudden worsening of glucose (sugar) control, weight gain, swelling, leg cramps and withdrawal syndrome, and adrenal suppression."
FDA lab analysis of the products revealed the presence of several prescription drugs that are linked to serious side effects, the agency said.
Dexamethasone, a corticosteroid commonly used to treat inflammatory conditions, can weaken the immune system, elevate blood sugar levels and increase the risk of bone and muscle injuries. It's also been associated with psychiatric problems.
When taken over long periods of time or in high doses, the drug may damage the adrenal glands, impairing their ability to produce hormones. Sudden discontinued use, especially when the drug has been taken long-term or in high doses, may lead to withdrawal syndrome, with users experiencing fatigue, nausea, low blood pressure, low blood sugar levels, fever, dizziness, and muscle and joint pain.
Diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID) also detected in the supplements, increases the risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal problems including bleeding, ulceration, and fatal perforation of the stomach and intestines. Additionally, the analysis found the muscle relaxant methocarbamol, which can cause drowsiness, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks, such as driving a motor vehicle or operating machinery.
Tests on samples of Reumofan Plus found it contained diclofenac sodium and methocarbamol, the FDA said.
"The hidden drug ingredients in Reumofan Plus and Reumofan Plus Premium can lead to serious, even life-threatening, health consequences. The longer you take the products, the higher the risk," Clark-Lynn said. "Because of the hidden corticosteroid, consumers taking these products are urged to immediately consult with their doctor to safely discontinue use of the product."
Dr. Stephen Dahmer, an integrated medicine family physician in private practice at the Continuum Center for Health and Healing, Beth Israel Medical Center, said supplements can be as dangerous as medications. "Anyone can have an adverse or allergic reaction to almost any supplement so you do need to be careful about what you take and make sure you only buy reputable, high quality brands," he said.
None of his patients has taken Reumofan but he urged anyone with osteoarthritis to steer clear. And he said he's on the lookout for symptoms in patients who suffer from arthritis in case they've taken the pills without telling him.
The supplements are manufactured in Mexico by the company Riger Naturals. They are usually labeled in Spanish but may also be labeled in English. In the U.S., GNC, Vitamin Shoppe and other large national retailers don't appear to be carrying the products either on the shelves or on their websites, but they can easily be purchased on supplement websites or eBay.
The Mexican Ministry of Health issued its own health warning to the public about Reumofan and has ordered Riger Naturals to recall the products. The FDA is asking doctors and consumers to report any side effects related to the two supplements to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.