Drugs

Advisors Asked About Pediatric Singulair Neuropsych Events

A 9/27 joint meeting of the FDA Pediatric Advisory Committee and Drug Safety and Risk Management Committee is seeking members’ comments on a pediatric-focused safety review of neuropsychiatric events with the use of montelukast (Merck’s Singulair) asthma and allergy drug. An agency briefing document released in advance of the meeting says safety concerns about neuropsychiatric events with montelukast and other leukotriene modifiers date back to 2007, when FDA opened an investigation follow a request by Merck to update the labeling with information on tremor, depression, and suicidal behavior.

FDA ultimately required a Warning and Precaution for neuropsychiatric events in the prescribing information and patient information leaflet. The Warning and Precaution have been updated since then, the document says, and there has been continued interest and discussion with stakeholders about the safety issue.

At the meeting, FDA will present its findings from a review of the data in the FDA adverse event reporting system database and a study in the Sentinel distributed database. The agency seeks advisors’ input on regulatory options for labeling and recommendations for communications strategies related to the risk of neuropsychiatric side events of montelukast in pediatric patients.

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