Topic:

Drug Safety

Latest Headlines

Latest Headlines

FDA adds PML death scenario to Tecfidera label

When Biogen Idec reported last month that a patient taking its hot multiple sclerosis pill Tecfidera had developed a rare brain infection and died, the drugmaker said it believed the safety profile of the drug remained solid. Perhaps so, but the FDA has decided the death was important enough to add a description of it on Tecfidera labels.

Baxter labeling issue could leave patients short on potassium chloride

For the second time in four months, Baxter International finds itself recalling highly concentrated potassium chloride. This time it's a labeling problem, one that the company says has the potential to be life-threatening.

Survey raises the question: Do patients really know how to use drug delivery devices?

Patients are overconfident in their ability to operate drug delivery medical devices and may not realize that they are using them incorrectly, a comprehensive survey by the U.K.'s Team Consulting shows.

Are farmed fish contributing to the rise of antibiotic resistance?

How can the aquaculture industry lead the way to responsible use of antibiotics without sacrificing food safety and endangering human health? That question was posed recently by The Fish Site, published by U.K.-based agricultural data provider 5m.

Japan unveils sunshine data of its own, raising eyebrows after Diovan scandal

Just as the dust is settling after the big rollout of doctor-payment data in the U.S., a new round has made its debut--in Japan. According to The Japan News, the country's top 10 drugmakers shelled out 190 billion yen ($1.66 billion) to doctors in fiscal 2013 in the form of research payments, speaking fees, entertainment, medical seminars and the like.

UPDATED: Intercept shares tank as investigators question OCA's safety/efficacy for NASH

After crunching the data on Intercept's clinical study of OCA for nonalcoholic steatohepatitis, investigators say they tracked some distinct improvements for patients suffering from the liver disease. But they also fretted about some troubling safety issues as well as inadequate efficacy endpoints that will have to be carefully considered in follow-up studies, tempering some of the high excitement that has been stoked by some analysts and the biotech's investors ahead of a pivotal Phase III study.

Zilmax is safe, Merck says. But will the meat industry buy it?

When it comes to cattle feed additive Zilmax, pulled from the market last year on concerning side-effect reports, there's nothing to worry about, Merck says. After a comprehensive review, the drugmaker has determined the product is safe when used according to its label. Now it just has to convince the meat-packing industry.

Big relief for Takeda, Lilly as judge slashes $9B Actos award by 99%

That scary $9 billion damages award a Louisiana jury slapped on Takeda and Eli Lilly earlier this year? A U.S. district judge slashed the bill by more than 99%, saying the new amount is the biggest award allowed under current law.

Can't stop gambling or shopping? Parkinson's meds may be to blame, JAMA study finds

When Parkinson's disease patients start taking new meds, doctors go on the lookout for the usual side effects: dizziness, nausea, and the like. But according to a new study, they need to think weird, too. The risk of compulsive behavior--gambling, shopping, sex--is much higher than previously thought.

FDA warns of contaminated Chinese meds after toddler suffers lead poisoning

The problem of contaminated cold remedies has once again surfaced in the U.S. More than seven years after diethylene glycol put authorities on high alert, a toddler in New York has suffered from lead poisoning after taking a Chinese cold remedy.