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Novo Nordisk filed five more lawsuits against businesses selling compounded semaglutide. Dr. Tim Mackey spoke about the dangers of the unregulated semaglutide sales online, and South Africa warned residents about counterfeit Ozempic.
Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.
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.
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.
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.
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.
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