comprehensive -WSS

comprehensive

author：leisure time 2025-10-01 21:47:46 - browse：16656

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： Psychedelics group wrestles with new pharma identity
Next article： Medicare proceeds with plan to claw back hospital funds

knowledge

WSS

Readout Newsletter: Medeor's stem cell study, Moderna's stock dip

Kidney transplant patients stopped immunosuppressants in trial

How to protect patients from sexual assault

A rare thyroid diagnosis led to unexpected, all

Kidney transplant patients stopped immunosuppressants in trial

The (many) problems with a new study criticizing cancer screening

knowledge

comprehensive

focus

Trump demands the U.S. pay no more for drugs than other countries … again

Readout LOUD podcast: ESMO highlights & Roivant's big deal

George Santos makes 1st court appearance after pleading not guilty to 13 counts

Humans aren't the only ones with an imagination. Rats have it too

Heart attack and stroke risk calculators need revising

Medicare must police algorithms in Medicare Advantage, Dems say

George Santos makes 1st court appearance after pleading not guilty to 13 counts

Biotech execs pursue obesity drug boom: ‘It’s the early innings’

BioMarin wins approval for gene therapy to treat hemophilia A

How to protect patients from sexual assault

Wikipedia

Humans aren't the only ones with an imagination. Rats have it too

Sarepta Duchenne therapy fails to meet primary endpoint in trial

Sarepta Duchenne therapy fails to meet primary endpoint in trial

Medicaid rebukes states for mistakenly disenrolling children

Readout LOUD podcast: ESMO highlights & Roivant's big deal

After Sarepta trial failure, Duchenne families brace for more debate

explore

explore

knowledge

hotspot