All herbal safety warnings and alerts
The U.S. Food and Drug Administration (FDA) has issued a second warning to consumers about the potential health risks of two products marketed in the USA as natural dietary supplements. There have been no adverse drug reactions regarding this product in the UK.
Reumofan Plus and Reumofan Plus Premium
Reumofan Plus is marketed in the USA as a natural dietary supplement for pain relief. The FDA laboratory analysis found that it contains diclofenac sodium, a prescription non-steroidal anti-inflammatory drug (NSAID) and Methocarbomal, a prescription muscle relaxant. Additionally, the Mexican Ministry of Health discovered at least one lot which contained the corticosteroid dexamethasone, an anti-inflammatory and immune system suppressant.
Reason for warning:
These products are advertised for the treatment of arthritis, muscle pain, osteoporosis, bone cancer, and other conditions and contain several potentially harmful active pharmaceutical ingredients that are not listed on the product labels.
In June 2012, the FDA issued a warning that they had received multiple reports of adverse reactions suspected to be 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 manufactured in Mexico by Rigers Naturals and is sold in the USA at retail outlets but it is also available on the internet.
Possible side effects:
The FDA has received dozens of additional adverse reaction reports, some of which have included serious adverse reactions including severe bleeding, stroke, withdrawal reactions and death which are suspected to be associated with the use of Reumofan Plus since the agency issued its first warning about the product.
Consumers who are taking these products or who have recently stopped taking Reumofan Plus or Reumofan Plus Premium should immediately consult a health care professional. Consumers should not buy or start using these products.
Reumofan Plus: Recall - Undeclared Drug Ingredient (external link)