The FDA is advising consumers not to purchase or use Pyrola Advanced Joint Formula, a product promoted for joint pain and sold on various websites, including www.amazon.com, and in some retail stores.
FDA laboratory analysis confirmed Pyrola Advanced Joint Formula contains diclofenac. Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). 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. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.
Laboratory analysis also confirmed that Pyrola Advanced Joint Formula contains chlorpheniramine. Chlorpheniramine is an over-the-counter (OTC) antihistamine used for allergies. Antihistamines may cause drowsiness and affect mental alertness.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program