Reumofan Plus Tablets
August 22, 2012
In June 2012, an FDA laboratory analysis found Reumofan Plus Tablets contained diclofenac sodium, a prescription non-steroidal anti-inflammatory drug (NSAID), and methocarbamol, a prescription muscle relaxant. The Mexican Ministry of Health found one lot of Reumofan Plus contained dexamethasone, a prescription corticosteroid with anti-inflammatory and immunosuppressant properties. Reumofan Plus is manufactured by the Mexican company Riger Naturals and is sold on the internet and in some flea markets and retail stores. It is labeled in Spanish and marketed to treat a variety of pain syndromes. The Mexican Ministry of Health has recalled Reumofan Plus.
Adrenal suppression and other symptoms of corticosteroid toxicity in patients taking Reumofan Plus were reported to FDA prior to June 2012 when this alert was originally issued. Since that time, FDA has received additional reports of corticosteroid withdrawal symptoms, renal and hepatic dysfunction, hyperglycemia, gastrointestinal bleeding, dizziness, stroke, and death associated with use of Rheumofan Plus products. Advise patients to avoid purchasing or using Rheumofan Plus products and to contact a healthcare professional if they are currently or have recently taken Reumofan Plus. A dose-taper may be necessary to prevent adverse effects from abrupt discontinuation of dexamethasone. Evaluate patients who used Reumofan Plus for drug-drug and drug-disease interactions with methocarbamol, diclofenac, and dexamethasone. Inquire about use of Reumofan Plus in patients with unexplained symptoms consistent with NSAID toxicity or corticosteroid withdrawal.
Report any related adverse events to FDA’s MedWatch Adverse Event Reporting program online: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
Additional information is available at the following links:
- MedWatch Alert:
- FDA News Release, June 1, 2012:
- FDA News Release, August 21, 2012
- Consumer Update
August 21, 2012; June 4, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.