Monday, November 27, 2023
FDA is notifying consumers of certain products marketed for pain and/or gout that have been found to contain hidden ingredients and might pose a significant health risk.
- Himalayan Pain Relief Tea contains hidden drug ingredients
- Tepee Herbal Tea contains hidden drug ingredient
- Notoginseng Formula Special Gout Granule contains hidden drug ingredients
Immediate public notifications are issued when FDA testing finds that a product contains active drug ingredients not listed on the product labels, possibly including ingredients found in prescription drugs. These products might cause potentially serious side effects and might interact with medications or dietary supplements a consumer is taking. Consumers should use caution when considering purchasing these types of products.
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FDA's health fraud product database includes only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of products.
Consumers and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
MedWatch Safety Reportin
FDA is warning consumers to not purchase or use any Neptune’s Fix products, or any other product with tianeptine -- a potentially dangerous substance that is not FDA-approved for any medical use but is illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions. FDA has received severe adverse event reports after use of Neptune‘s Fix products, including seizures and loss of consciousness leading to hospitalization. Consumers who experience a bad reaction to any tianeptine product should seek immediate medical help. Neptune Fix’s labels state the product contains tianeptine, but may contain other harmful ingredients not listed on the label. These products, like other tianeptine products, can be purchased online and at gas stations, vape or smoke shops, or other locations. FDA is testing these products and will provide more information as it becomes available. FDA also continues to warn consumers about risks of using tianeptine. |
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CVM Antimicrobial Stewardship in FY 2023 and Beyond
By Bill Flynn, DVM, MS, Deputy Director of FDA’s Center for Veterinary Medicine
Today, we kick off Antimicrobial Awareness Week, held every year from November 18-24. This recognition is a great opportunity to reflect upon what we at FDA’s Center for Veterinary Medicine (CVM) are doing to address antimicrobial resistance (AMR) and preserve the effectiveness of these critical and life-saving drugs. In this post, I’m mainly going to focus on what we accomplished in FY 2023.
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Cardinal Health Recalls Monoject Disposable Syringes for Incompatibilities with Syringe Pumps
FDA’s Center for Veterinary Medicine is sharing news of this recall to alert veterinarians who may be using this product.
In June 2023, Cardinal Health began distributing Monoject syringes branded as “Cardinal Health Monoject syringes.” These new syringes differ from the previously branded “Covidien Monoject syringes” as they have different dimensions.
The affected Cardinal Health Monoject syringes should not be used with syringe pumps. The dimensional changes made to the affected Cardinal Health Monoject syringes when used with syringe pumps may result in pump performance issues such as overdose, underdose, delay in therapy, and delays in occlusion alarms.
Cardinal Health has received 15 reports of delayed therapy due to syringe infusion pumps not recognizing syringes, and 13 reports of inaccurate volume/rate dispensing, including some injuries. Cardinal Health has not received any reports of patient death.
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FDA Approves Pregabalin Oral Solution for Alleviating Anxiety Associated with Transportation and Veterinary Visits in Cats
Today the U.S. Food and Drug Administration approved Bonqat (pregabalin oral solution) for the alleviation of acute anxiety and fear associated with transportation and veterinary visits in cats. The drug is administered orally approximately 1.5 hours before the start of the transportation or veterinary visit and can be given on two consecutive days. Bonqat is the first FDA-approved animal drug containing pregabalin.
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