RECALL: Reumofan Plus Contains Undeclared Ingredients
The FDA is warning consumers and healthcare professionals that Reumofan Plus, marketed for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful.
A laboratory analysis found that it contains diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID) that may increase risk of cardiovascular events, as well as serious gastrointestinal adverse events including bleeding, ulceration, and fatal perforation of the stomach and intestines. It was also found to contain methocarbamol, a muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to drive a motor vehicle or operate machinery.
In addition, the Mexican Ministry of Health discovered that at least one lot of the product contains dexamethasone, a corticosteroid that acts as an anti-inflammatory and immune system suppressant.
The FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression. Reumofan Plus is manufactured in Mexico by Riger Naturals and is sold in some retail outlets, at flea markets, and on various internet sites. Consumers who are currently taking or who recently stopped taking Reumofan Plus are urged to consult a healthcare professional immediately.
For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm306360.htm.