Reumofan Plus Recalled due to Undeclared Ingredients that Can be Harmful

FDA informs consumers, Health Professionals and Emergency Medicine personnel that Reumofan Plus is recalled because it contains several active pharmaceutical ingredients that can lead to severe adverse events.

Background of Reumofan Plus

Reumofan Plus, manufactured by Riger Naturals in Mexico, is marketed as a natural dietary supplement for pain relief and other serious conditions including arthritis, osteoporosis and bone cancer.

Reumofan Plus

It is sold at flea markets, retail outlets, and via internet. The Mexican Ministry of Health ordered the manufacturer to recall Reumofan Plus and warned the public.

FDA Alert on Reumofan Plus

FDA conducted lab analysis of Reumofan Plus and found it contained undeclared diclofenac sodium and methocarbamol. Diclofenac sodium may increase the risk of cardiovascular event and serious gastrointestinal adverse events. Methocarbamol can cause low blood pressure and sedation, impairing physical and mental activities.

Moreover, the FDA received several reports of adverse events from Reumofan Plus including swelling and liver injury. The corticosteroid dexamethasone was also discovered by the Mexican Ministry of Health in at least one lot of Reumofan Plus. This drug suppresses the immune system.

Recommendation on Reumofan Plus

“Consumers who are currently taking or who recently stopped taking Reumofan Plus are urged to consult a healthcare professional immediately. Health care professionals are urged to ask their patients about use of Reumofan Plus and other products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, depression, or the use or abrupt discontinuation of corticosteroids.

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

Contacting the FDA to report cases with Reumofan Plus

In case of detection of adverse events or side effects related to the use of Reumofan Plus, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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