Drug Safety

Latest Headlines

Latest Headlines

J&J again faces off-label marketing claims in Risperdal case of boy who grew breasts

Last week opening arguments were made in a case in which Johnson & Johnson is accused of marketing the antipsychotic drug Risperdal for use in young boys and then not sufficiently warning patients that the side effects for some included the possibility they would grow breasts like a woman.

India's GVK Biosciences gets harsh accusations from EMA on fake generic trials

In a no-holds-barred action, the European Medicines Agency has accused India-based CRO GVK Biosciences of systematically faking clinical trials for about 700 generic drugs marketed throughout the world. The products of dozens of generic makers are among the drugs involved, including popular antidepressants.

Report: Merck said to be testing lower dosage Zilmax to revive sales

Merck is financing a $1.85 million study being conducted at Texas Tech University to see if lower dosages of its lucrative but controversial cattle growth drug Zilmax could allow the company to reintroduce the product to U.S. and global markets and kick-start sales.

BD must still pay $350M+ due to safety syringe spat; other punishments delayed pending appeal

A federal court has upheld the $350 million-plus in damages that Becton Dickinson owes Retractactable Technologies due to a legal spat over drug-delivering prefilled syringes. But the court stayed a previous order requiring the company to inform end users about its false advertising regarding the syringes.

FDA links saline supply chain mixup to patient death

The saline shortage may have claimed a life. The FDA reported that one person has died and many more have taken ill after receiving simulated intravenous products that are intended for training use only.

Extended-release drugs to face extra scrutiny from FDA's new Office of Pharmaceutical Quality

"Modified release is a high-risk area, so we're going to put a lot of emphasis on it," said the deputy director of the FDA's new Office of Pharmaceutical Quality, Lawrence Yu, during a press conference describing the new division.

Petco banishes China-made treats from shelves

Pet retail chain Petco announced on its new blog Pet Talk Place that it has removed all dog and cat treats made in China from its store shelves, becoming the first national retailer to do so.

New study clears Merck's blockbuster Gardasil of MS risk

Good news for Merck: According to a new study, its cash cow vaccine, HPV-blocker Gardasil, isn't linked to an increased risk of multiple sclerosis--or any other similar CNS diseases, for that matter.

Hospira recalls cancer med that was focus of warning letter

Hospira, which has continued its struggles with manufacturing quality, closed out the year with a recall, and it was a big one. The Illinois-based company issued a worldwide recall of the cancer med mitoxantrone that was manufactured at a plant in Australia that the FDA savaged in a warning letter last year for not figuring out why tests showed its potency was too low and its impurities too high.

GVK feels the sting after data scandal

Improprieties at a GVK Biosciences facility in India have led some European countries to pull medicines from shelves, and the resulting fallout is cutting into the CRO's profits.