FDA Issues Warning For Reumofan Dietary Supplement

FDA Issues Warning For Reumofan Dietary SupplementThe U.S. Food & Drug Administration (FDA) just issued a warning for Reumofan Plus dietary supplements due to the presence of potentially harmful pharmaceutical ingredients.

Reumofan Plus is marketed as a “natural” dietary supplement for pain relief and other serious conditions; however, the product contains several active pharmaceutical ingredients that are not listed on the label and that could be harmful. The FDA warns consumers who are currently taking Reumofan Plus or who have recently stopped taking Reumofan Plus to immediately consult a health care professional. Consumers should not buy or start using the recalled Reumofan Plus product.

Reumofan Plus is labeled in Spanish and is promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and is sold in some retail outlets, at flea markets, and on various Internet sites. The FDA indicated that it is collaborating closely on this matter with the Mexican government and that the  Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product.

To date, the FDA has received multiple reports of adverse events associated with the use of Reumofan Plus. Reports include 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, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation of the stomach and intestines.
•    Methocarbamol: A prescription muscle relaxant that can cause sedation, dizziness, low blood pressure. Methocarbamo can impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.

These ingredients also may interact with other medications and result in serious adverse events.

The Mexican Ministry of Health also discovered that at least one lot of the recalled Reumofan Plus contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant. And, according to FDA adverse events reports, consumers reported symptoms suggesting that some lots of Reumofan Plus may contain corticosteroids. At least one report from a health care professional treating a patient with adverse events from using Reumofan Plus, confirmed adrenal suppression. Abrupt discontinuation of corticosteroids after long-term or high-dose use can lead to fatigue, nausea, low blood pressure, low blood sugar levels, fever, muscle, and joint pain, dizziness, and fainting.

Health care professionals are urged to speak to their patients about Reumofan Plus use and use of 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. Health care professionals should also evaluate patients who have used Reumofan Plus for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider if a corticosteroid taper regimen may be appropriate in those who have taken Reumofan Plus.

Health care professionals and consumers are encouraged to report any adverse events related to Reumofan Plus to FDA’s MedWatch Safety Information and Adverse Event Reporting Program: Online at www.fda.gov/Medwatch/report.htm; by phone 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 at to 1.800.FDA.0178.

This entry was posted in Pharmaceuticals and tagged . Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.