[6-5-2015] The Food and Drug Administration (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:
- Complete and submit the report online 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 a growing trend of dietary supplements or conventional foods with hidden drugs 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.
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