Well, there is bad, then there is worse!  In this case, the FDA warns us about a product that is being marketed as all natural and promoted as a dietary supplement for joint and muscle pain.  The product, called Trinity Gold, actually contains three undeclared drug ingredients, acetaminophen, diclofenac, and phenylbutazone (which was removed from the U.S. market for safety reasons).

The Agency warns that the inclusion of undeclared acetaminophen could pose a significant problem for patients who also take acetaminophen in any other form, including OTC or prescription products, due to the potential risk of liver injury.

“Diclofenac is a non-steroidal anti-inflammatory drug (NSAID).  NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines.”  In addition, it could cause serious adverse events if taken with other prescription or OTC products that also contain NSAIDs.

Phenylbutazone and another, similar NSAID were the subject of a 1984 Federal Register Notice (here) that announced a public hearing on the safety of the drugs as they are “associated with many fatal cases of aplastic anemia or pancytopenia (severe depression of red blood cell production or generalized depression of bone marrow cell production), agranulocytosis (severe depression of white blood cell (granulocyte) production leading to increased susceptibility to infection), leukemia (cancer of the bone marrow), gastrointestinal bleeding, and peptic ulceration.  HRG also notes that the drugs are associated with fatal cases of hepatitis, thrombocytopenia (depression of platelet formation), and kidney failure.”  Phenylbutazone was subsequently withdrawn from the U.S. market in 1985.

In its public announcement regarding Trinity Gold (here), the FDA states that “[t]his notification is to inform the public of products marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals.  These products are typically promoted for sexual enhancement, weight loss, pain and body building and are often represented as being ‘all natural.’  FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients.  Consumers should exercise caution before purchasing any product in the above categories.”

The origin of this product was not disclosed in the announcement but many products claiming to be dietary ingredients are imported into the U.S. from foreign sources; however, some of these illegal products are also manufactured in the U.S.