Drugs

Supreme Court May Hear Paxil Warning Case

The Supreme Court may decide at a 4/26 conference whether to hear arguments in a case involving adequacy of warnings of adult suicidality for a generic form of GlaxoSmithKline’s Paxil (paroxetine). The Cook County Reporter says the case was brought by the widow of a Chicago attorney who committed suicide in 2010 after taking paroxetine. The suit claims that the paroxetine label, which was written by Glaxo and was identical to the Paxil label, did not adequately warn the drug could increase the risk of suicide.

The suit says the plaintiff claims the company knew of the alleged risk of suicide and chose not to revise the label, while the company says FDA declined all of its attempts to make a labeling change. An Illinois federal jury found against Glaxo and the company appealed to the 7^th Circuit Court of Appeals, which overturned the verdict. The plaintiff then appealed to the Supreme Court.

The plaintiff’s attorneys say the 7^th Circuit decision conflicts with one from the 3^rd Circuit involving Merck’s Fosamax. That case was argued before the Supreme Court in January, the article says, and a decision could be issued in the next few weeks. Plaintiffs in the Paxil case have asked the justices not to decide whether to take their case until the Fosmax case is decided.

Glaxo said there was no reason to wait for the Fosamax case because the 7^th Circuit had found that “no reasonable jury could find that FDA would have approved an adult suicidality warning for Paxil between 2007 and 2010.” The company also challenged the suit on the basis that it can’t be held responsible for injuries allegedly caused by a generic product over which it has no control.

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