FDA Warns Reumofan Dietary Supplements Contain Harmful Drug Ingredients, Linked to Reports of Stroke and Death

The U.S. Food & Drug Administration (FDA) just issued a warning to consumers concerning Reumofan Plus and Reumofan Plus Premium supplements, and that they contain harmful drug ingredients

Reumofan Plus and Reumofan Plus Premium supplements are marketed as natural dietary supplements taken for the treatment of arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. Both Reumofan Plus and Reumofan Plus Premium contain a number of potentially harmful, active pharmaceutical ingredients that are not listed on the products’ labels.

The agency also indicated that it has received dozens of additional adverse event reports that have included reports of death and stroke linked to Reumofan Plus since it first issued a warning about the supplement on June 1, 2012. Other reports have been received that include liver injury, severe bleeding, sudden worsening of glucose (sugar) control, weight gain, swelling, leg cramps and withdrawal syndrome, and adrenal suppression, the FDA said in its warning.

The agency warns consumers who are taking these products or who have recently stopped taking Reumofan Plus or Reumofan Plus Premium to immediately consult a health care professional. Consumers should not buy or start using Reumofan Plus and Reumofan Plus Premium supplements. Meanwhile, ongoing FDA laboratory analyses of Reumofan Plus found that it contains the following prescription drug ingredients:

  •  The corticosteroid dexamethasone, which is typically used to treat inflammatory conditions. This ingredient can impair the body’s ability to fight infections and cause high blood sugar levels, bone and muscle injuries, psychiatric problems, and adrenal suppression when taken for a prolonged time or at high doses. Sudden discontinuation of corticosteroids after long-term use or use at high doses can result in a withdrawal syndrome: Fatigue, nausea, low blood pressure, low blood sugar levels, fever, dizziness, and muscle and joint pain.
  • Diclofenac sodium is a non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events (heart attack, stroke) and serious gastrointestinal (GI) adverse events such as bleeding, ulceration, and fatal perforation of the stomach and intestines.
  • The muscle relaxant methocarbamol can cause sedation, dizziness, and low blood pressure, and can impair mental or physical abilities to perform tasks (driving a motor vehicle, operating machinery).

A separate FDA lab analysis of Reumofan Plus Premium found that it contains two of these ingredients: diclofenac sodium and methocarbamol. Also, both products are labeled in Spanish, but there may be English-labeled versions on the market. The products are made in Mexico by Riger Naturals and sold in the U.S. in some retail outlets, at flea markets, and Internet sites.

The FDA also warns that the hidden drug ingredients in Reumofan Plus and Reumofan Plus Premium may interact with other medications and result in serious adverse events.

Health care professionals should evaluate patients who have used Reumofan Plus and/or Reumofan Plus Premium for drug and disease interactions and consider a corticosteroid taper regimen, if appropriate. Additional information on consumers’ risks may be accessed on the FDA web site at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm316315.htm

Health care professionals and consumers are encouraged to report adverse events related to Reumofan Plus and Reumofan Plus Premium to FDA’s MedWatch Safety Information and Adverse Event Reporting Program: Online at www.fda.gov/Medwatch/report.htm; by telephone at 1.800.FDA.1088 (1.800.332.1088); or, by returning FDA form 3500, available on the MedWatch “Download Forms” page, by mail, to the address on the pre-addressed form or by fax to 1.800.FDA.0178.

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