Drug Safety

Latest Headlines

Latest Headlines

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.

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.

Fund grows to $200M for victims of meningitis outbreak tied to compounder

A fund for victims of a fungal meningitis outbreak that sprung from contaminated drugs sold by the now-defunct New England Compounding Center has reached $200 million, twice what was initially expected.

FDA proposes new rules for animal drug compounding

On May 17, the FDA announced that it released a draft guidance that sets out rules for compounding animal drugs from bulk substances. In so doing, the FDA is recognizing that in some situations, treating animals with specially formulated versions of approved drugs would be impossible.

FDA makes strides in inspection effort but challenges persist

In a report to Congress this week, the Office of Inspector General said that the number of inspections of generic drugmakers, preapproval and so-called surveillance inspections, were up to 243 in 2013 from 149 in 2011, a 63% jump. The vast majority of those were combined inspections for both preapproval applications and to check on general GMP conditions.

Attix Pharmaceuticals recalls hundreds of APIs from the U.S.

A Canadian-based company that sources active pharmaceutical ingredients from China and repackages them in Toronto is recalling hundreds of bulk APIs sold in the past three years because the facility where they were packaged didn't adequately separate penicillin APIs from the rest.

3M says its new intravenous port dressing will make drug delivery easier and fight off site infections

3M announced the launch of its Tegarderm CHG intravenous port dressing, saying the device will help oncology patients receive injections comfortably and ward off infection. The new product combines a transparent port-site dressing with a chlorhexidine gluconate gel pad. 3M says the dressing enables continuous, unobstructed observation of the IV insertion site.

Sanofi sues drug information startup over side effect info

Sanofi is suing startup Diagnosia over the publication of information about side effects and drug interactions in its physician decision support software.