Drug Safety

Latest Headlines

Latest Headlines

Hikma says FDA has closed out warning letter for EU injectables plant

Just over a year ago, a Hikma sterile injectables plant in Portugal was grilled in a warning letter for a variety of failings, some that the FDA said it had been warned about before. But Jordan-based Hikma said today that the FDA has indicated those problems are behind it.

Advera Health: Novartis, GSK asthma meds linked to more side effects than Merck drugs

Bestselling asthma drugs from Novartis and respiratory behemoth GlaxoSmithKline are also showing more adverse events in post-marketing safety data than competing products from Merck, according to a new report, potentially presenting issues further down the line as companies duke it out for market share.

UPDATED: J&J slapped with $1.75M verdict in Risperdal breast growth case

Johnson & Johnson lost another courtroom battle over claims that the company failed to warn doctors and patients that its antipsychotic drug Risperdal could cause breast growth in boys, a blow for the company as it continues to deal with related cases.

UPDATED: Chicago makes second run at Allergan, J&J, Purdue and others with painkiller lawsuit

Opioid makers thought they had dodged a litigation bullet 6 months ago when a federal judge dismissed a lawsuit by the City of Chicago trying to hold them accountable for an "epidemic" of painkiller, and even heroin, abuse. But the city is being tenacious and has refiled lawsuits claiming 6 drugmakers overstated the claims of the drugs' benefits while downplaying their risks.

Sanofi recalls epinephrine injectors that may be giving wrong dose

Sanofi has stopped manufacturing its epinephrine injection devices and is scrambling to retrieve nearly half a million from the U.S. and Canada because they may be giving the wrong dose. The recall came after Sanofi received more than two dozen reports of patients who had an adverse reaction after using their injector.

FDA warning on AbbVie hep C drugs gut kicks its share price

AbbVie's Viekira Pak and Technivie were developed to cure hepatitis C and so avoid the complications like liver transplants that can result from the disease. But the FDA said today that in some cases the two drugs may cause serious liver injury, even death, mostly in patients with underlying advanced liver disease, and told AbbVie it would have to add a warning to its labels.

J&J chalks up a win in first Tylenol liver-damage case to go to trial

Johnson & Johnson scored a victory in the first case to go to trial over claims that its blockbuster painkiller Tylenol causes liver damage and its dosing doesn't adequately account for the risk. A New Jersey jury ruled that the plaintiff did not prove that she took the painkiller.

FDA's review of BI's Pradaxa was 'lax' and 'permissive,' watchdog claims

Boehringer Ingelheim's next-gen anticoagulant, Pradaxa, has been plagued by safety worries that have cropped up since its 2010 FDA approval. And according to one watchdog group, that's because the agency was "lax" and "permissive" in reviewing the drug in the first place.

Advera: AbbVie's Viekira Pak riskier than Gilead's Harvoni for hep C

AbbVie is facing bad news for its hep C powerhouse Viekira Pak as it dukes it out for dominance with Gilead Sciences in the hep C market. Healthcare informatics firm Advera Health Analytics looked at new side effect post-marketing safety reports on hep C treatments, including those for Gilead's Sovaldi and Harvoni and AbbVie's Viekira Pak, and found that AbbVie's drug was the riskiest option among the three meds.

Takeda keeps Actos settlement ball rolling with new resolutions

Takeda is settling the score with two plaintiffs over allegedly hiding cancer risks linked to its diabetes drug Actos, almost a month after the company announced that it would complete a settlement program that would resolve most of its pending litigation for similar claims over the med.