Jun. 12th, 2012

Food

US FDA Issues Alert on Reumofan Plus, a Health Food

Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA is working with the Mexican government on this matter and an agency order has been issued to recall the product. The FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose (sugar) control, weight gain, swelling, leg cramps, and adrenal suppression (problems with kidney functioning). An FDA laboratory analysis of Reumofan Plus found that it contains diclofenac sodium, a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events such as heart attack and stroke, and methocarbamol, a prescription muscle relaxant that can cause sedation, dizziness and low blood pressure, etc. FDA is urging health care professionals to ask their patients about use of Reumofan Plus and other products marketed dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, depression, or abrupt discontinuation of corticosteroids.

Newsletter Subscription

Sign up to receive event invitations, expert insights, timely news alerts, and other updates.

SUBSCRIBE

Contact Us

REACH24H USA

+1 703 596 8055

REACH24H EU

+353 1 8899 951

REACH24H UK

+44 203 5822996

REACH24H China

+86 571 87103805

REACH24H Korea

+82 2 62451610

REACH24H Japan

+03 5005 0662

REACH24H Singapore

Events

Demystifying EU Health Claims: Regulation and Authorization GRAS and Beyond: U.S. Market Entry Pathways for Novel Food Ingredient
Full Image