Reumofan Plus has been recalled due to undeclared drug ingredients, the U.S. Food and Drug Administration announced in a press release.
Reumofan Plus is a dietary supplement designed to help treat arthritis, muscle pain, osteoporosis, bone cancer and other painful conditions, according to the FDA.
"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 (causing a hole) of the stomach and intestines, and Methocarbamol, a prescription muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery," the press release explained.
In addition, the Mexican Ministry of Health found that at least one lot contained dexamethasone, an anti-inflammatory and immune system suppressant, according to the FDA. The Mexican government has also ordered a recall.
The FDA has received many adverse event reports associated with Reumofan Plus use, including liver injury, sudden worsening of blood sugar control, weight gain, swelling, leg cramps, and adrenal suppression.
The FDA urges consumers who have taken Reumofan Plus to consult with their health care professionals immediately. Health care professionals should consider tapering the patient off the drug with a round of corticosteroids.
Patients and healthcare professionals should report adverse events or side effects related to the use of Reumofan Plus to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. The form can be submitted online or by calling 1-800-332-1088.