The FDA says Reumofan Plus, a dietary supplement manufactured in Mexico but sold widely on the internet and at some retail outlets and flea markets, contains unlisted ingredients that could seriously harm users.
Consumers who are taking Reumofan Plus or who have recently stopped taking Reumofan Plus should immediately tell their doctor, the FDA advises. Consumers also should not buy or start using the product, the agency says.
Reumofan Plus is marketed as a “natural” dietary supplement for muscle and joint pain associated with arthritis, osteoporosis, bone cancer and other conditions. Its labels are in Spanish.
Lab analysis by the FDA shows the pills contain:
- Diclofenac sodium, a prescription non-steroidal anti-inflammatory drug (NSAID) associated with increased risk of heart attack and stroke, serious internal bleeding, ulcers, and fatal perforation (holes) in the stomach and intestines.
- Methocarbamol – a prescription muscle relaxant that can cause sedation, dizziness and low blood pressure and therefore interfere with abilities to drive or operate machinery.
The FDA says it has received multiple reports of adverse events associated with the supplement, including liver injury, sudden worsening of glucose (sugar) control, weight gain, swelling, leg cramps, and adrenal suppression (problems with kidney functioning).
At least one lot of the product contains a corticosteroid called dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant. People who stop taking corticosteroids abruptly after using them for a long time or at high doses may experience fatigue, nausea, low blood pressure, low blood sugar levels, fever, muscle and joint pain, dizziness, and fainting.
The Mexican government has ordered a recall of Reumoflan Plus by its manufacturer, Riger Naturals of Mexico.
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, or by phone at 800-332-1088.
If you’ve taken the drug and been hospitalized as a result, be sure to talk to a reputable Boston personal injury attorney about your legal options.