comprehensive -WSS

comprehensive

author：explore 2025-10-01 15:29:04 - browse：53437

The back of three medicine containers, a bottle in between two boxes, all showing labels — coverage from STAT — Adobe

After a drug enters the market, it’s up to Food and Drug Administration regulators to ensure its continued safety and efficacy. A recent New York Times story suggests that, in the case of the popular asthma drug Singulair, the FDA fell short — both because the agency delayed action for years on reports from patient advocates and independent groups that the drug could cause suicidal thoughts, and because when it did add a warning label about its potential side effects in 2020, clinicians and patients still weren’t always aware of the risks.

Experts say that the Singulair incident highlights a flawed system, both in the U.S. and globally, for monitoring adverse reactions after a drug is on the market — one that will require extensive changes to address.

“The question is, how safe do you want to be?” said Ameet Sarpatwari, the assistant director of the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital. Ideally, he said, the FDA should be able to both stay on top of safety concerns and avoid unnecessarily restricting access to drugs. “Are we at the right balance? I think there are definitely situations for many drugs where you can say, no, we’re not really at the right balance, and the FDA should be taking a more aggressive stance in promoting patient safety.”

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： The high cost of giving birth even with insurance
Next article： Diversifying clinical trials isn't enough to close racial gaps: study

Wikipedia

focus

WSS

Researchers explore possible ties between long Covid, menopause

Impact of Dobbs ruling felt at reproductive medicine meeting

Hospital price transparency does save money, advocate argues

Cassava reveals details — and problems — with Alzheimer's study

The pink breast cancer awareness ribbon needs a redesign

STAT Readout Newsletter: Today's biggest biotech updates

hotspot

comprehensive

entertainment

After affirmative action ruling, medical educators look to 'holistic review'

CEOs share strategies for surviving biotech slump

Alkermes shareholders re

Diversifying clinical trials isn't enough to close racial gaps: study

Hollywood unions extend contract negotiations for actors

FDA approves Eli Lilly ulcerative colitis treatment Omvoh

Over 800 arrested across France in 3rd night of riots after fatal police shooting of teen

Traditional Chinese medicine benefits explored in new JAMA study

After affirmative action ruling, medical educators look to 'holistic review'

Biden's order seeks to regulate AI risk without stifling innovation

knowledge

FDA warns J&J's Abiomed: We will regulate your software

Emergency medicine has repudiated 'excited delirium.' Now what?

Chimpanzees, like humans and whales, get menopause: Study

Readout Newsletter: XBI biotech index, Akero Therapeutics

Readout Newsletter: New research from Sanofi, Regeneron, etc.

The explosion of genetic testing requires a new approach

explore

Wikipedia

focus

hotspot