FDA Alert: Three Dietary Supplement Consumer Warnings, All Contain Prescription APIs
Consumer Warnings on Three Dietary Supplements Containing Undeclared Steroids and NSAIDs
May 8, 2023
The FDA has issued consumer warnings on three different dietary supplement sold as herbal compounds intended to treat joint pain, rheumatoid arthritis, gout, and liver detoxification. Each product contains undeclared prescription drug ingredients.
- UA-Block contains indomethacin, a non steroidal anti-inflammatory drug (NSAID) not listed in the contents.
- New Fast-Act Rheumatism Capsule also contains indomethacin which is not listed in the contents.
- Fast-Act Rheuma Capsule contains prednisone-21-acetate, a corticosteroid, along with piroxicam, a non-steroidal anti-inflammatory drug (NSAID). Neither drug compound is listed in the ingredients.
Indomethacin is one of the most potent NSAIDs and is generally only used after other NSAIDs have proved ineffective. NSAIDs (including indomethacin) have been associated with an increased risk of stroke or heart attack.
Piroxicam is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and help relieve symptoms of arthritis (e.g., osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. Systemic piroxicam poses a significantly greater risk of serious gastrointestinal toxicity than other NSAIDs, including gastrointestinal hemorrhage, ulceration, and perforation.
Prednisone is a corticosteroid that can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland. Abrupt discontinuation can cause withdrawal symptoms.
The FDA notes that these "hidden drug ingredients may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products."
Healthcare professionals and consumers should report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or;
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Note: This 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, 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.