FDA drug safety updates: ADZYNMA, Tazverik, Tavneos, Depo-Provera, statin SAMS, gas-X, duloxetine, lacosamide recall, Corlanor/Sensipar, cinacalcet, XOCOVA, menopause hormone therapy label change, fenofibrate recall, chlorthalidone recall, Omnitrope recall, and many more
Key Questions
What prompted Health Canada to halt new TAVNEOS initiations?
Data integrity concerns in the ADVOCATE trial led to the halt, alongside 74 serious liver injuries, 8 deaths, and NEJM retraction.
Which eye drops were recalled in large quantities?
Over 2.5 million bottles of Lupin prednisolone acetate were recalled for foreign substance contamination across multiple lots through 2028.
What caused Amgen’s massive Corlanor and Sensipar recall?
Nearly 1 million bottles were recalled due to foreign substance presence, classified as Class II with specific NDC and lot details.
How does the new Oxford statin calculator help patients?
It provides personalized risk estimates for serious muscle disorders based on 5.6M records, showing over 98% of users face low risk.
What label change occurred for menopause hormone therapy?
FDA removed three of four black-box warnings from 2003 WHI-era labeling, potentially affecting prescribing for younger symptomatic women.
Which drugs face nitrosamine or dissolution recalls?
Duloxetine (375K bottles) and chlorthalidone (11K bottles) were recalled for nitrosamine impurities and dissolution failures respectively.
What safety signals were identified for bispecific antibodies?
FAERS analysis flagged unlabeled risks like PML, HLH, DIC, and TB for epcoritamab, glofitamab, and mosunetuzumab.
Are there recalls for HGH or cholesterol medications?
Omnitrope cartridges were recalled for cracking/leaking risks, and fenofibrate lots for CGMP deviations affecting thousands of units.
New: Tavneos recall pressure escalating – EU joins FDA seeking market removal, false data allegations, 74 serious liver injuries, 8 deaths, VBDS requiring transplant. Health Canada halts new TAVNEOS initiations due to data integrity concerns in ADVOCATE trial, NEJM retraction. Also new: Lacosamide 30,000 bottle recall (mix-up with Selexipag, Class II). Duloxetine recall (375K bottles, nitrosamine, Class II) – now with specific Breckenridge lot numbers for 30mg/60mg capsules. New: Amgen recall of nearly 1M bottles of Corlanor and Sensipar (foreign substance, Class II, specific NDC/lot numbers). New: Cinacalcet 30 mg recall (Amgen, CGMP deviations, Class II). Also new: FAERS study on CD3×CD20 bispecific antibodies (epcoritamab, glofitamab, mosunetuzumab) identifies unlabelled serious safety signals (PML, HLH, DIC, TB, cerebral hemorrhage); pharmacovigilance study flags SJS/TEN risk for clobazam and lacosamide. New: U-500 insulin dosing errors – article provides strategies to prevent fivefold wrong dose errors. New: XOCOVA (ensitrelvir) label for COVID-19 prophylaxis – key safety signals: embryofetal toxicity, CYP3A interactions, hypersensitivity. New: FDA stripped black-box warning off menopause hormone therapy – removing three of four black-box warnings from 2003 WHI era; mismatch between WHI trial population (older, asymptomatic) and typical users (younger, symptomatic) could shift prescribing patterns. New: FAERS/JADER study on AI + CDK4/6 inhibitor combo identifies 150 ADEs including unlabeled signals (skin hypopigmentation, plicated tongue). New: Statin research gap for postmenopausal women – SWAN study shows lipid spikes at menopause and estrogen's drug-like effects, challenging routine statin prescribing without considering menopausal metabolic shifts. New: Fenofibrate 200mg recall (Ajanta Pharma, Class II, CGMP deviations, lot PA02216, 3,648 units) – relevant for cholesterol medication safety. New: Lupin prednisolone acetate eye drops recall (2.5M bottles, foreign substance, Class II, multiple lot codes through 2028) – important for patients using steroid eye drops. New: Oxford statin side effect risk calculator (5.6M patient records) – personalized risk estimates for serious muscle disorders, >98% low risk, addresses adherence barrier. New: TAVNEOS (avacopan) – Health Canada halts new initiations due to data integrity concerns in ADVOCATE trial, NEJM retraction; 74 serious liver injuries, 8 deaths, VBDS requiring transplant. New: Nature Medicine piece on hidden side effects in oncology (CTCAE gaps, daraxonrasib example) – important for patient education on cancer drug risks. New: Chlorthalidone 25mg recall (Class II, 11,460 bottles, dissolution failure, specific NDC/batch numbers) – minor addition for diuretic safety. New: Omnitrope (somatropin) injectable HGH recall – Sandoz Canada, cartridges cracking/leaking, lots PR7350/PR7351, risk of contamination and underdosing.