Drugs

Appeals Court Reverses GSK $3 Million Liability Suit

The U.S. Court of Appeals for the Seventh Circuit has reversed a lower court decision and $3 million verdict in a product liability case that attempted to hold GlaxoSmithKline (GSK) responsible for injuries caused by a drug, paroxetine, it neither manufactured nor sold. The appeals court decision held that federal law prevented GSK from adding a warning about the alleged association between paroxetine and suicide in adults.

In the suit, Wendy Dolin alleged that her husband Stewart’s 2010 suicide was caused by paroxetine, which is used to treat depression and anxiety. Stewart never took GSK’s branded paroxetine, Paxil. Instead, he took a generic manufactured by Mylan Pharmaceuticals. Because generic drug warnings should be identical to the brand drug, the plaintiff argued that GSK was liable for not having an adequate label for generics to copy.

But GSK had sought FDA approval to add to Paxil’s label a warning about an increased risk of suicide. The agency repeatedly refused the company’s request.

The appeals court agreed with GSK that under preemption, federal law prevented GSK from adding a warning about the alleged association between paroxetine and suicides in adults.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome