Topic:

Drug Safety

Latest Headlines

Latest Headlines

Emerging markets tipped to push drug safety software market past $150M

Analysts at MarketsandMarkets have looked into their crystal ball and come up with a forecast of the pharmacovigilance and drug safety software sector. The authors predict the value of the market will top $150 million by 2019, with Asia and Latin America tipped to be the driving forces behind growth over the next few years.

Critics say White House plan to combat antibiotic resistance falls 'woefully short'

The Obama Administration rolled out its 5-year plan to combat antibiotic-resistant bacteria on Thursday, and it was met with widespread disdain from critics who say it doesn't do enough to prevent livestock producers from using the drugs in ways that endanger both animal and human health.

Geriatrics experts call for halt to Low-T consumer ads

A couple of geriatrics experts have joined the chorus of recommendations against testosterone therapy. But they're going a step further. They say drugmakers' enthusiastic advertising--which happened to be effective, too--was actually disease-mongering.

FDA lets Lilly's long-acting Zyprexa off the hook in patient deaths

The FDA says it won't recommend new limits on Eli Lilly schizophrenia med Zyprexa Relprevv after almost a year of investigating the deaths of two patients 3 to 4 days after they received injections.

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.