News
FDA Alert: Dietary Supplement Contains Drug That Can Cause Heart Attack, Stroke and Internal Bleeding
Use of products with undeclared diclofenac 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.
[...]November 11, 2024: Feds pursue companies selling fentanyl precursors
Another China-based chemical company was indicted for allegedly selling precursor chemicals and xylazine to U.S. buyers as Americans continue to grapple with the toll of counterfeit prescription pills made with dangerous drugs.
[...]FDA Alert: Compounding Pharmacy in California Warned After Particulates Found in Injections
On August 14, 2024, FDA received a complaint from a patient who noticed a black particulate in a vial of semaglutide distributed by Fullerton Wellness. On September 23, 2024, FDA received information from California regulatory authorities as part of ongoing collaboration between FDA and the state noting deficiencies found at Fullerton Wellness during a state inspection. After the state inspection, Fullerton Wellness voluntarily ceased operations.
[...]FDA Alert: FDA Reminds Compounders to Use Appropriate and Sterile Ingredients
The agency urges manufacturers, including repackagers, to clearly identify any ingredients intended for use in foods or dietary supplements on the label. Providing this information on ingredient labels could help prevent compounders from using ingredients that are not appropriate for sterile drugs and may help prevent patient harm.
[...]November 4, 2024: The FDA continues to work for patient safety
This week the agency warned about compounding safety and sterility issues and a newly posted document shows inspectors enforcing manufacturing standards.
[...]October 28, 2024: DOJ hands down indictments and patients harmed by formulary change
Chinese companies and individuals indicted by the Department of Justice and a study examines how patients were harmed by the sudden removal of a medication from a drug formulary.
[...]A DSCSA-newbies guide to the recent FDA DSCSA announcement
The FDA recently announced that “connected trading partners” that have made progress in transmitting electronic data that identifies and follow medicines made for the U.S. drug supply will not be penalized if they are still working out challenges in the process. Are you wondering what that means? We can explain.
[...]October 21, 2024: PSM advisory board member leads petition for tariffs over fentanyl precursors from China
Family advocates petition the Office of U.S. Trade Representative to take trade action over Chinese fentanyl precursors. The New York Times tackles PBMs and pharmacy deserts.
[...]FDA Alert: Pain Relief-Marketed Dietary Supplement Recalled For Containing Prescription Steroids, Muscle Relaxants, and OTC Pain Relievers
Consumers taking this product should immediately consult with their health care professional to safely discontinue use of this product. The risks of withdrawal from corticosteroids should be assessed by a healthcare professional. Only licensed health care professionals can evaluate patients for the risk, or confirm the existence, of adrenal suppression. Consumers that have product which is being recalled should return to place of purchase or discard.
[...]October 15, 2024: FDA issues new DSCSA guidance
The FDA granted exemptions for certain trading partners and small dispensers to avoid supply chain disruptions. Stories from the week in counterfeit medicine news.
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