![]() ![]() Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market.įDA encourages consumers and health care professionals to report any adverse events to the agency’s MedWatch Adverse Event Reporting program so the agency can take action to protect the public from any unsafe products. FDA cannot test all products on the market that contain potentially harmful hidden ingredients. It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers. Consumers should use caution when considering purchasing these types of products. These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking. The public notifications listed below include those products FDA testing found to contain active drug ingredients not listed on the product labels, including some with ingredients found in prescription drugs. Consumers should exercise caution before purchasing any product in the above categories.FDA is notifying consumers of certain products promoted for arthritis and pain management that have been found to contain hidden ingredients and may pose a significant health risk. 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. Note: This notification is to inform the public of products marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals. Download and complete the form, then submit it via fax at 1-80.Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or.Health care 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: Methocarbamol can also impair mental and physical abilities to perform certain tasks, such as driving a motor vehicle or operating machinery. Methocarbamol is a muscle relaxant that can cause sedation, dizziness, and low blood pressure. 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. 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, the undeclared dexamethasone in Ortiga Mas Ajo Rey Extra Forte may cause serious side effects when combined with other medications.ĭiclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). Abrupt discontinuation can cause withdrawal symptoms. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland. ![]() ![]() Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries and psychiatric problems. ![]() Only licensed health care professionals can evaluate patients for the risk, or confirm the existence, of adrenal suppression.ĭexamethasone is a corticosteroid commonly used to treat inflammatory conditions. The risks of withdrawal from corticosteroids should be assessed by a health care professional. FDA laboratory analysis confirmed that Ortiga Mas Ajo Rey Extra Forte contains diclofenac, dexamethasone, and methocarbamol not listed on the product label.Ĭonsumers taking Ortiga Mas Ajo Rey Extra Forte should immediately consult with their health care professional to safely discontinue use of this product. ![]()
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