Drug Safety

Latest Headlines

Latest Headlines

Biogen confirms second PML case among Tecfidera patients

Biogen has confirmed another case of progressive multifocal leukoencephalopathy in a patient on its oral MS-fighter Tecfidera, though this one--unlike the last--was nonfatal.

FDA scales up CV warnings on NSAIDs

The FDA already had a warning out about the cardiovascular safety of nonsteroidal anti-inflammatory drugs, or NSAIDs. But on Thursday, it strengthened that warning for both prescription and OTC meds.

BMJ: Pfizer, Allergan antidepressants show no links to birth defects

Antidepressants have long been linked to an increased risk of birth defects, with companies fighting claims that the meds cause serious issues in newborns if women take the drugs during pregnancy. Now, a new study published in the British Medical Journal shows that only some of the drugs turn up risks of birth defects, dealing a spate of good news to companies making the products.

Poll: Parents view vaccines as safer, more beneficial

A new national poll shows that parents' views on vaccines became more favorable between 2014 and 2015, the same period that multiple outbreaks of measles and whooping cough unrolled around the country.

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A team of Stanford University scientists think they have found a potential reason why GlaxoSmithKline's now-withdrawn flu shot Pandemrix was associated with a spike in narcolepsy cases.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