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Drug Safety

Latest Headlines

Latest Headlines

UPDATED: Safety concerns cloud odanacatib PhIII as Merck steps back from FDA filing

A growing buzz about potential safety issues has raised a cloud of doubt about Merck's osteoporosis drug odanacatib, which is likely to linger now that the pharma giant has released Phase III results and laid out plans for a delayed FDA filing.

Study: Roche's cheaper Avastin just as safe as Lucentis in eye disease

The nonprofit Cochrane Collaboration, which reviews clinical trial data to determine the value of pharmaceuticals, is going after Lucentis, which is used to treat the blinding eye disease age-related macular degeneration.

WHO calls on drug industry, governments to get Ebola therapies to patients

In a desperate attempt to control the ongoing Ebola outbreak in West Africa, the World Health Organization is appealing to drug companies and international regulatory bodies to work together to get experimental therapies and vaccines out of the lab and into the clinic as soon as possible.

FDA still wishy-washy on Low-T drugs' pros and cons

With a Sept. 17 meeting on the horizon to discuss the risks and benefits of testosterone-raising meds--so-called Low-T drugs--the FDA has posted a review on the topic. But its stance is neither here nor there.

China sweeps up gang that made and sold 90M toxic capsules

China has interrupted another group it says was illegally manufacturing capsules from chromium-laced gelatin. A lot of them.

Boehringer Ingelheim still being dogged by Ben Venue plant

Boehringer Ingelheim is finding it difficult to get the stink of the troubled Ben Venue Bedford, OH, operations off its shoes. It closed the site last year and sold it last month but is still having to recall products produced there that might be contaminated.

Takeda and Lilly remain on the hook for $9B Actos award

Legal experts have insisted there is no way that a $9 billion punitive damage award against Takeda Pharmaceutical and Eli Lilly for hiding Actos risks can stand. But the two companies are still sweating that one out after a federal judge refused to throw out the verdict and its mammoth award on Thursday.

Study sounds alarm on sleep-aid ingredient zolpidem

Sleep aids have landed in the safety spotlight recently, with regulatory agencies lowering dosages on some meds to ease side effect worries. But overmedication has its own set of risks, and a new study says those resulted in a doubling of emergency department visits between 2005 and 2010.

Black box warning for antidepressants spelled the death of litigation

There used to be a legal specialty built by plaintiff attorneys around filing lawsuits against antidepressant makers and then settling them. But the black box warning put on antidepressants in 2004 has turned out to be a shroud for the once lucrative legal business.

Teva recalls Parkinson's disease drug because it may be 'superpotent'

Teva Pharmaceutical Industries, whose manufacturing operation is being signifcantly pared down, is recalling one lot of its generic Parkinson's combo drug carbidopa/levodopa because it may have too much active pharmaceutical ingredient.