THE DRUG DOCKETA 9 October labelling supplement folds results from two post-marketing rheumatoid-arthritis safety studies into the JAK inhibitor baricitinib's boxed warning, and revises its infection and cardiovascular sections.
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THE DRUG DOCKETThe Class I recall covers 625,500 prefilled syringes. Cartons labelled morphine sulfate 2 mg/mL hold a Dilaudid (hydromorphone) syringe of 0.5 mg/0.5 mL instead — the wrong opioid at the wrong dose.
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THE DRUG DOCKETThe FDA classified the nationwide recall Class I, its most serious tier. About 31,935 multi-dose vials are affected, with particulate identified as nylon, glass and other materials, plus broken and leaking units.
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As RTS,S reached more than 2 million children in Ghana, Kenya and Malawi, a WHO-coordinated pilot trained about 6,000 health workers to detect and report side-effects that most rollouts assume can already be caught.
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THE DRUG DOCKETA 411,000-patient claims study found adults on GLP-1 drugs who started oxycodone had more severe constipation and bowel obstruction at 30 days than those starting hydrocodone or tramadol.
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EXPLAINERThe older oral preventives managed 0.44 to 1.4. The larger change is that the new drugs work in people the old ones failed, and are tolerated well enough to stay taken.
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ANALYSISAn analysis of the FDA's voluntary reporting database finds herbal and weight-loss products carry the highest serious-outcome rate. The author is explicit that these are flags for investigation, not proven risks.
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THE DRUG DOCKETA five-year FAERS analysis found both semaglutide and tirzepatide carry disproportionate ketoacidosis signals in people without diabetes, with roughly three-quarters of reported cases requiring hospitalization.
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THE DRUG DOCKETSemaglutide showed a sixfold reporting signal for polycystic ovary syndrome and a smaller but real alopecia signal. Dulaglutide and tirzepatide showed lower or no signal for the same reproductive events.
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THE DRUG DOCKETBoth drugs suppress ovarian and testicular hormone production, but two decades of FDA safety reports show leuprolide skewing toward reproductive and cancer-related signals, goserelin toward endocrine ones.
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THE DRUG DOCKETTwo trials showed more deaths on voxelotor than placebo. The registry data that triggered the 2024 precautionary suspension did not confirm the original signal — the trials did something worse.
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