Category: Policy Alerts
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FDA Flags Serious Liver Injury Linked to Tavneos (Avacopan)
Tavneos (avacopan) is a prescription medication approved in 2021 to help treat severe active anti‑neutrophil cytoplasmic autoantibody (ANCA)‑associated vasculitis, a rare autoimmune disease that causes inflammation of small blood vessels. For many patients, Tavneos offered a new option to control a difficult and potentially life‑threatening condition. Now, the U.S. Food and Drug Administration (FDA) says
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New FDA Warning: Carbidopa & Levodopa Can Cause Vitamin B6 Deficiency and Seizures – What Patients Need to Know
The FDA has told drug makers to add a warning to all products containing carbidopa & levodopa – the most common medicines for Parkinson’s symptoms – because these drugs can lower vitamin B6 (pyridoxine) and have been linked to vitamin B6 deficiency–associated seizures. The agency reviewed reports and asked manufacturers to update prescribing information so
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FDA Requests Removal of Suicidal Behavior Warning from GLP‑1 Medications
Glucagon‑like peptide‑1 receptor agonists (GLP‑1 RAs) have become some of the most widely discussed medications in recent years – largely because of their role in weight loss and diabetes management. Drugs like Wegovy, Saxenda, and Zepbound have helped millions of people manage obesity and improve metabolic health. But until recently, these medications carried a warning
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Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection
Fresenius Kabi has issued a voluntary nationwide recall of three lots of Famotidine Injection USP, 20 mg per 2 mL (10 mg/mL), after laboratory testing identified an out‑of‑specification impurity result in a single lot. The recall is precautionary and intended to protect patients and maintain supply-chain integrity while further investigations continue.1 Summary of the recall
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FDA Recall: Over 480K bottles of Teva’s Prazosin Hydrochloride
Teva Pharmaceuticals USA initiated a voluntary, nationwide recall of multiple lots of Prazosin Hydrochloride capsules after laboratory testing found levels of an N‑nitroso impurity (designated N‑nitroso Prazosin impurity C) above the FDA’s acceptable intake limit calculated using the Carcinogenic Potency Categorization Approach (CPCA). The agency classified the recall as Class II, indicating that use of
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Changes to Medicare Drug Plans for 2026
The landscape of Medicare prescription drug coverage is poised for considerable transformation in 2026, bringing a blend of policy-driven reforms, technical updates, and new beneficiary protections. These changes, shaped largely by ongoing implementation of the Inflation Reduction Act (IRA) of 2022, affect every facet of Medicare Part D – including out-of-pocket costs, coverage scope, accessibility,
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FDA Withholds Drugmaker Names After Contamination Findings
The U.S. Food and Drug Administration (FDA) occupies a pivotal position in protecting public health by regulating the safety, efficacy, and quality of drugs available in America. Yet, as recent investigative reporting has revealed, for decades the FDA has routinely redacted the names of drugs and their corresponding manufacturers from inspection reports when foreign factories