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Drug Safety

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Latest From Drug Safety

Sprout’s Addyi Loses Blanket Alcohol Contraindication And REMS Distribution Restrictions

US FDA’s approval of labeling supplements for the hypoactive sexual desire disorder drug followed Sprout’s appeal of a safety-related change order; boxed warning now states patients should wait at least two hours after drinking alcohol before taking flibanserin.

Drug Safety Post Market Regulation & Studies

Dopamine Agonists: US FDA Orders Safety Labeling Changes But Not Boxed Warnings

Agency denies citizen petition requests for boxed warning on risk of impulse control behaviors and other psychiatric disorders with the class of drugs used to treat Parkinson’s disease and restless legs syndrome, but agrees with one petitioner that some safety-related changes are warranted.

Drug Safety Neurology

Cefiderocol Approval Likely After Panel Vote, But Future Still Clouded

Shionogi's cUTI drug clears US FDA advisory committee by 14-2, though a black box warning is possible after one of the clinical studies showed a potential mortality imbalance disfavoring cefiderocol in other diseases.

Advisory Committees Infectious Diseases

EMA Stands Firm On Estradiol Cream Safety Measure After Doubts Over Impartiality

After a 14-year-old legal dispute, the European Medicines Agency has now repeated its safety review of high-strength estradiol creams for treating vaginal atrophy and says it stands by its original recommendation to place a limit on how long patients should use these products.

Europe Drug Safety

Pink Sheet Podcast: Makena's Accelerated Approval Questions, Woodcock On Biobetters, Singulair's Safety Issues

Pink Sheet reporters discuss the upcoming Makena advisory committee meeting, Janet Woodcock's recent comments on the biosimilar market, and options for new safety communications for Singulair.

Advisory Committees Drug Safety

'Dear Doctor Mom' – US FDA Urged To Find Way To Reach Pediatric Patient Parents With Safety Updates

How should FDA make sure new safety information gets widely disseminated – especially against a history of many communications that have not shown the sustained ability to reach the most active prescribers? The agency got an earful of suggestions from the most recent safety review of the asthma/allergy drug montelukast.

Drug Safety Advisory Committees

Big Tech Helping US FDA With Sentinel Expansion

Amazon, Microsoft, IBM among those helping build new operations and innovation centers for the US FDA's safety surveillance system.

Drug Safety Post Market Regulation & Studies

Servier Denies Deceit As French Mediator Trial Begins

A trial has begun in France to investigate the roles of the French firm Servier and the former drug regulator AFSSAPS in the Mediator scandal, where an amphetamine-like drug was kept on the market despite mounting evidence of its cardiac side-effects.

France Drug Safety

Black Box On Singulair Doubtful After US FDA Panel Offers Divided Opinion

Joint panel of the Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee was split on whether the US FDA should add a black box warning to the label of Merck's now generic Singulair, which is currently labeled with a warning and precaution about a risk of psychiatric events.

Advisory Committees Pediatrics
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