FDA Warns Again on Painkiller Supplement
By Cole Petrochko, Associate Staff Writer, MedPage Today
Published: August 22, 2012
WASHINGTON -- The FDA has issued a new warning against a Mexican "natural"
dietary supplement marketed for pain relief due to unlabeled and potentially
harmful drug ingredients.
Ongoing lab analysis of the supplements found that Reumofan Plus and
Reumofan Plus Premium contain at least three unlabeled drug ingredients,
Dexamethasone: a corticosteroid that can cause withdrawal syndrome if
discontinued after long periods of use or high doses
Diclofenac sodium: a nonsteroidal anti-inflammatory drug (NSAID) that can
increase risk of serious cardiovascular and gastrointestinal events
Methocarbamol: a muscle relaxant that can cause sedation, dizziness,
hypotension, and impaired mental and physical abilities
The agency issued an initial warning against the products in June, 2012, due
to adverse event reports that included incidents of liver injury, sudden
worsening of glucose control, weight gain, swelling, leg cramps, and adrenal
suppression. Since that warning was issued, the FDA has received reports of
severe bleeding and withdrawal syndrome, the agency said in a statement
The Mexican Ministry of Health ordered manufacturer Riger Naturals to recall
the products prior to the initial FDA warning.
The supplements are marketed as a treatment for arthritis, muscle pain,
osteoporosis, bone cancer, and other conditions. They are sold in flea
markets, online, and at some retail outlets using Spanish labeling, though
the agency noted that samples may exist with English labeling.