Topic:

Drug Safety

Latest Headlines

Latest Headlines

Scientists dig up new evidence linking GSK's Pandemrix with narcolepsy

A team of Stanford University scientists think they have found a potential reason why GlaxoSmithKline's now-withdrawn flu shot Pandemrix was associated with a spike in narcolepsy cases.

AdverseEvents flags TB reports, blood-disorder cases linked to RA drugs

Drugmakers are eager to jump on the rheumatoid arthritis (RA) bandwagon, concentrating on tried-and-true treatments to bring in sales or developing new therapies to stave off looming biosimilars competition. But the meds come with their own set of safety issues, as both TNF-alpha treatments and non-TNF alpha drugs continue to generate troubling side effect reports.

FDA warns that transdermal patch for ADHD can lead to permanent skin discoloration

The FDA warned that a transdermal patch used to treat ADHD in children and adolescents can lead to chemical leukoderma, or permanent skin discoloration, as a result of the skin's repeated exposure to specific chemical compounds.

Europe bans some APIs from Chinese drugmaker Zhuhai United

China's Zhuhai United Laboratories bills itself as the world's largest manufacturer of the API for the antibiotic amoxicillin. But the sterile manufacturing for some of its amoxicillin products has been called into question by inspectors in Europe, which is banning the sterile drugs for now, except in limited cases.

Akorn's Hi-Tech source of another recall

When Akorn bought Hi-Tech Pharmacal a couple of years ago, CEO Raj Rai called the $640 million deal transformative. Most recently, what has transformed for Illinois-based Akorn is recalls tied to manufacturing issues at Hi-Tech.

UPDATED: AdverseEvents: Diabetes drug analysis flags heart failure, pancreatitis reports

Drugmakers are hot to trot after diabetes meds, and for good reason--the disease population is large, and growing. But the drugs have raised a few eyebrows lately, with regulators taking aim at safety issues tied to SGLT2 and DPP-4 drugs in particular. And SGLT2 and DPP-4 meds are not the only offenders, as side effect reports continue to mount for GLP-1 drugs.

You want to quash 'Low-T' overprescription, FDA? Quash DTC ads, experts urge

After warning that casual use of testosterone meds can cause heart attack and stroke, the FDA has finally put its foot down to curb overprescribing of the drugs. But some say the agency needs to go further.

Consumer group demands FDA correct 'compounded mistake' on Vanda's Hetlioz label

The FDA has already admitted that it made a mistake with its initial approval letter for Vanda Pharmaceuticals' sleep disorder drug early last year, a consumer advocacy group says. And now, that group is demanding the agency do a better job fixing it.

Pfizer in quick succession turns aside second lawsuit alleging Zoloft birth defects ties

Just weeks after winning the first case to go to trial that accused Pfizer of hiding birth defect risks for the children of women who took the antidepressant Zoloft during pregnancy, the pharma giant has again convinced a jury that there was no credible connection. The results are positive for Pfizer, but the company still faces more than 1,000 lawsuits alleging similar claims.

Big Data study flags 'fairly compelling' link between stomach blockbusters and heart risks

Proton pump inhibitors, including AstraZeneca's longtime blockbuster Nexium, are some of the most commonly used drugs in the world to treat heartburn. But they may also be increasing the risk of heart attack, a new study shows.