Home Page Potential Lawsuit FDA Issues Warning About Serious Adverse Events with Reumofan Plus
FDA Issues Warning About Serious Adverse Events with Reumofan Plus
Washington, DC: The Food and Drug Administration (FDA) is warning consumers that Reumofan Plus, marketed as a natural dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful. Health officials in Mexico have ordered a recall based on potentially harmful pharmaceutical ingredients.
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.
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.
These ingredients also may interact with other medications and result in serious adverse events.
The Mexican Ministry of Health discovered that at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant.
FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression.
Reumofan Plus is marketed as a natural dietary supplement for pain relief. Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product.
Legal HelpIf you or a loved one has suffered adverse events, injury, death or damages in this case, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Last updated on Jun-1-12
READ MORE [ Defective Products Settlements and Legal News ]
READ MORE [ Drugs/Medical Settlements and Legal News ]
ADD YOUR COMMENT ON THIS ISSUE