Case in point ...
From Medical News: The FDA issued a warning to consumers against using a a Mexican "natural" dietary supplement promoted for pain relief due to unlabeled and potentially harmful pharmaceutical ingredients.
The warning for Reumofan Plus was issued after the agency received a number of adverse event reports, including incidences of liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression.
After a laboratory analysis, the agency found Reumofan Plus contains the prescription drugs diclofenac sodium and methocarbamol.
Diclofenac sodium is a nonsteroidal anti-inflammatory drug that may cause cardiovascular events such as heart attack and stroke as well as serious gastrointestinal adverse events including bleeding, ulceration, and fatal perforation of the stomach and intestines, the FDA said in a statement.
Methocarbamol is a muscle relaxant that can cause sedation, dizziness, hypotension and can impair mental and physical performance to drive or operate machinery.
Additional analysis by the Mexican Ministry of Health uncovered that at least one lot of the product contained the corticosteroid dexamethasone, which acts as an anti-inflammatory and immune system suppressant.
The FDA warned that these unlabeled components of Reumofan Plus may put patients taking other medications at risk for adverse drug interactions.
It cautioned that patients taking corticosteroids may be at risk for fatigue, nausea, hypotension, low blood sugar levels, fever, muscle and joint pain, and fainting if they discontinue Reumofan Plus use abruptly after prolonged or high-dose exposure.
Medical News: Supplement Laced with Harmful Meds - in Public Health & Policy, FDA General from MedPage Today
