focus -WSS

focus

author：Wikipedia 2025-09-06 04:14:19 - browse：8

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： Medicare proposal to cover medical devices draws a mixed reaction
Next article： H5N1 communication has been strictly for the birds

explore

hotspot

WSS

Alcohol isn't healthy after all. Will new dietary guidelines reflect that?

Readout LOUD podcast: brain research, obesity drug sales, Novartis

Telehealth startups turn to complex chronic diseases

Researchers on aging grapple with how to calculate biological age

Apple Watch's A

Apple Watch's A

focus

focus

Wikipedia

Indiana Supreme Court upholds abortion ban, says state constitution gives only limited protections

Readout LOUD podcast: What to know about H5N1 bird flu

Dobbs anniversary: the lost opportunity of abortion as health care

Steward Health Care files for bankruptcy

Duchenne breakthrough therapy leaves behind pioneering families

Sanofi strikes deal with Novavax, boosting the vaccine maker

Novavax promises a turnaround & Lilly roils the obesity market

Steward Health Care files for bankruptcy

What does generative AI mean for health care? We asked experts

Alcohol isn't healthy after all. Will new dietary guidelines reflect that?

leisure time

What nurses really want: sufficient staffing for patient care

After gene therapy, two congenitally deaf children hear for the first time

After gene therapy, two congenitally deaf children hear for the first time

Dairy farmers resist CDC push for PPE against bird flu virus

Telehealth startups turn to complex chronic diseases

Readout LOUD podcast: brain research, obesity drug sales, Novartis

explore

hotspot

hotspot

entertainment