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, medetomidine signal, cetirizine recall, TGA ashwagandha alert, JAK inhibitor hypoglycemia warning, levothyroxine recall, Baxter cefazolin recall, Cyclophosphamide recall, Papaverine recall, alli kidney warning, Rohto eye drop recall, GLP-1 hair loss, FDA peptide panel conflict, Ascend Laboratories amlodipine/olmesartan recall, new ADHD drug Simtriyo label nuance, and dabigatran (Pradaxa) recall, plus California Supreme Court Gilead ruling, plus new fezolinetant (Veozah) liver injury and nightmare signals, plus levothyroxine recall details, plus Fresenius Kabi morphine syringe recall, plus apremilast pharmacovigilance study, plus new levothyroxine recall (Major Rugby, specific lot numbers), plus Lupin blood pressure tablets recall (carcinogen), plus new: EudraVigilance analysis of antidepressants and suicide risk, plus new: cetirizine recall (ranitidine cross-contamination, Class I), plus new: Victory Medical Center Pharmacy compounded glutathione recall (endotoxins), plus new: REBOOT trial beta blockers useless and dangerous for preserved heart function, plus new: FDA warning letters surge 59% due to over-reliance on AI

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. New: CDC warns of medetomidine as emerging drug safety signal – veterinary sedative found in illicit drug supply, causing severe sedation and respiratory depression. New: Cetirizine tablets recalled due to cross-contamination with ranitidine – risk of anaphylaxis in sensitive patients, specific lot numbers, no adverse events reported yet. Upgraded to Class I recall. New: TGA safety alert on ashwagandha and liver injury – 11 cases, all resolved on discontinuation; also flags GLP-1 eye disorder risk. New: FDA side effects update: JAK inhibitors (Xeljanz, Rinvoq) hypoglycemia warning in diabetes patients – adds to known risks, actionable for patients. New: Levothyroxine recall (subpotency) – widely used thyroid medication, specific lot numbers, actionable for patients. New: FDA proposes removing age-related hypogonadism limitation from TRT labels based on TRAVERSE trial cardiovascular safety data – significant label change, also updating prostate cancer contraindication to only metastatic disease. New: Baxter cefazolin in dextrose injection recall (cardboard particulate, risk of pulmonary emboli, specific lot numbers) – adds to injectable drug safety pattern. New: Cyclophosphamide for injection recall (steel particulate, risk of thromboembolic events, specific lot numbers) – adds to injectable drug safety pattern. New: Papaverine injection recall (glass and paraformaldehyde contamination, risk of stroke/death, single lot) – adds to injectable drug safety pattern. New: FDA adds kidney injury warning to OTC weight-loss drug alli (orlistat) – label change, aligns with prior alli kidney stone warning. New: Rohto eye drop recall (12M bottles, sterility concerns, Class II, specific lot numbers) – large-scale OTC recall, actionable for consumers. New: BMJ study finds GLP-1s linked to hair loss (alopecia) – 37-68% higher risk vs other diabetes drugs, likely due to rapid weight loss. New: RFK Jr.-stacked FDA panel approves peptides over scientists' objections – six of eight appointees sell peptides, conflict of interest. New: Ascend Laboratories recalls amlodipine/olmesartan 10/20 mg (6,192 bottles, dissolution failure, lot 25121311) – third such recall in a year, raises manufacturing quality concerns. New: New ADHD drug Simtriyo (centanafadine) approved – label calls it CNS stimulant despite nonstimulant headlines, carries abuse warning, modest efficacy vs stimulants – important labeling nuance for patient education. New: Dabigatran (Pradaxa) recall – 5,460 cartons for elevated degradation impurities, no adverse events reported, actionable for patients on blood thinners (do not stop abruptly). New: California Supreme Court rules Gilead not liable for delaying safer TAF version of tenofovir – major drug safety liability precedent affecting patient rights. New: FAERS analysis of fezolinetant (Veozah) confirms liver injury signals beyond trials, also flags nightmare as potential new side effect. Relevant for menopause drug safety education. New: Levothyroxine recall details: specific lot numbers and expiration dates from FDA warning. Actionable for patients. New: Fresenius Kabi morphine syringe recall (labeling mix-up with Dilaudid) – serious medication error risk, no adverse events reported yet. New: Apremilast pharmacovigilance study identifies new ADE signals (allergic reactions, tumors) not in label – adds to drug safety monitoring. New: Levothyroxine recall (Major Rugby, specific lot numbers, subpotency) – adds to thyroid medication recall pattern. New: Lupin blood pressure tablets recall (carcinogen contamination) – adds to manufacturing quality concerns. Latest: Another levothyroxine recall announced (subpotency, low health risk per manufacturer) – reinforces ongoing thyroid medication safety concerns. New: EudraVigilance analysis of antidepressants and suicide risk – venlafaxine highest completed suicides, duloxetine highest suicidal behavior, age-specific risks (sertraline in youth, duloxetine/venlafaxine in elderly), 94% underreporting. Important for patient education on monitoring during treatment initiation. New: Cetirizine recall (ranitidine cross-contamination, Class I) – adds to drug recall pattern. New: Victory Medical Center Pharmacy recalls compounded glutathione (elevated endotoxins, fever/hypotension risk, TX/FL/NY). New: REBOOT trial shows beta blockers after heart attack useless and possibly dangerous for patients with preserved heart function – women face 45% higher risk, challenging 40 years of routine prescribing. New: FDA warning letters surge 59% due to over-reliance on AI – industry context for drug safety regulation.