The U.S. Food and Drug Administration has issued a second warning about a “natural” dietary supplement being marketed for pain relief from arthritis. The agency says Reumofan Plus and Reumofan Plus Premium contain several potentially harmful drugs that are not listed on the products’ labels.
The FDA said it has received dozens of reports of health problems, including death and stroke, since it issued its first warning about Reumofan in June. Consumers also complained of liver injury, severe bleeding, weight gain, swelling, leg cramps, withdrawal syndrome, adrenal suppression, and sudden worsening of glucose (sugar) control.
“Consumers who are taking these products or who have recently stopped taking Reumofan Plus or Reumofan Plus Premium should immediately consult a health care professional. Consumers should not buy or start using these products,” the FDA said
Reumofan Plus and Reumofan Plus Premium are manufactured in Mexico by Riger Naturals and are mostly labeled in Spanish. The Mexican Ministry of Health ordered Riger Naturals to recall the products prior to the initial FDA warning, but some are apparently still being sold in the U.S. at retails outlets, flea markets and on the internet.
An FDA laboratory analysis of Reumofan Plus found that it contains three prescription drug ingredients that may interact with other medications:
Dexamethasone: A steroid commonly used to treat inflammation that can impair the body’s ability to fight infection and can cause high blood sugar levels, bone and muscle injuries and psychiatric problems.
Diclofenac sodium: A non-steroidal anti-inflammatory drug (NSAID) that may cause increased 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.
Methocarbamol: A muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities, such as driving or operating machinery.
A separate FDA lab test of Reumofan Plus Premium found that it contains both diclofenac sodium and methocarbamol.
“Health care professionals are urged to ask their patients about use of Reumofan Plus, Reumofan Plus Premium, and other similar products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, psychiatric changes, or the use or abrupt discontinuation of corticosteroids,” the FDA said.
A website based in California recently touted Reumofan Plus as an “all natural” product that “treats and prevents osteoporosis, osteoarthritis, muscle pain, joint pain, rheumatism, herniated disc and in addition prevents joint disorders and joint cancer.” It is no longer listed for sale on the website.