FDA Issues New Safety Alert on Reumofan Plus and Reumofan Plus Premium

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In August 21, the FDA issued a new warning to consumers about the potential health risks of two products marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The products, Reumofan Plus and Reumofan Plus Premium, contain potentially harmful active ingredients that are not listed on the product labels.

The FDA received dozens of additional adverse event reports, including death and stroke, associated with the use of Reumofan Plus after issuing 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, and adrenal suppression.

Ongoing FDA laboratory analyses of these products found that they contain the prescription drug ingredients dexamethasone, diclofenac sodium, and methocarbamol.

Manufactured in Mexico

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.

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 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.

Additionally, health-care professionals should evaluate patients who have used Reumofan Plus and/or Reumofan Plus Premium for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate. ■




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