Topic:

Drug Safety

Latest Headlines

Latest Headlines

Lawsuit would force FDA to ban or label wheat gluten as ingredient

Celiac sufferer Michael Weber is suing the FDA for dragging its feet on a citizen petition he filed in 2008. The lawsuit attempts to force the FDA to either ban gluten from use in drugs or at least require labels to indicate it is an ingredient in prescription and over-the-counter drugs.

FDA keeps black box on Pfizer's Chantix, adds new warning about alcohol

Pfizer has been lobbying the FDA to back off of the black-box warning on its stop-smoking drug Chantix. But patient groups and others have been pushing back--including a panel of FDA advisers, which voted last year to keep the agency's boldest warning on Chantix's official label.

EMA seeks input on new guidelines to combat antibiotics resistance

Following in the footsteps of the FDA, the European Medicines Agency (EMA) has launched an effort to combat antibiotics resistance in people by targeting food animals. The agency has issued two new draft guidelines for assessing and approving veterinary antibiotics.

Novartis CEO: We can rebuild our good name after 'reputational hit' in Japan

What's going to save Novartis' reputation in Japan? Science, says CEO Joe Jimenez, a week after the government suspended his Japanese unit for failure to report side effects.

FDA requires new labeling on insulin pens to ward off spread of infections

The FDA is taking action to ensure that multidose insulin pens do not spread diseases by requiring the injectable devices to display the warning "For single patient use only."

Medicare urged to crack down on antipsychotic scripts for dementia sufferers

The Obama administration is already working with nursing homes to reduce inappropriate use of antipsychotic meds such as Seroquel, Risperdal and Zyprexa. But federal investigators now say officials need to focus on overuse in dementia patients.

Sidelined after tampering incident, GSK's alli is back on sale

After nearly a year off the shelves, GlaxoSmithKline's diet pill alli--recalled after reports of tampering--is back in most U.S. stores, and it's got some updates that should make any future tampering easier to spot.

As Shire gears up to push Vyvanse for binge eating, critics worry about abuse

Shire is pushing full steam ahead to get the word out on binge eating disorder, the new indication it snagged for blockbuster Vyvanse last month.

J&J loses first court battle over Risperdal's breast-growth side effects

The jury has spoken in Johnson & Johnson's Risperdal trial, and the news wasn't good for the U.S.-based drugmaker. The Philadelphia panel decided J&J had failed to properly warn that the antipsychotic drug could trigger breast development in boys and young men, in the first of more than 1,000 similar cases pending.

WHO adopts new safety needle policy, calling smart syringes an 'urgent priority'

Citing rampant use of the same needle to inject more than one person, the World Health Organization has--some might say finally--launched a new policy to make unsafe injections less prevalent. Part of this policy involves adopting up-to-date measures in syringe engineering, promoting the use of "smart" needles with precautions against unsafe use.