Topic:

Drug Safety

Latest Headlines

Latest Headlines

Jury: Boy didn't prove J&J drug caused his breast growth

Johnson & Johnson won a split decision in Philadelphia court Friday, in the latest Risperdal lawsuit to go to trial. A jury decided that J&J did fail to warn doctors that the antipsychotic drug could cause breast development in boys, Reuters reports.

Gilead warns of fatal reaction to Sovaldi, Harvoni and heart drug

Gilead Sciences' superselling hepatitis C drugs have hit a speed bump after 9 patients taking either Harvoni or Sovaldi, as well as a common drug for heart arrhythmias, had serious reactions. One of the 9 had a heart attack and died. Three others had to receive pacemakers.

FDA hustles on opioid guidance to avoid budget meddling

The FDA is rushing to complete guidance on abuse-deterrent opioids before the end of June because if it doesn't, Congress has promised to take away $20 million in money for salaries and expenses in the FDA Commissioner's Office and give it instead to its criminal investigations unit to fight drug diversion.

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.