Drugs

FDA Sees Abilify Impulse-control Issues

FDA is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with using the antipsychotic drug aripiprazole (Otsuka’s Abilify and Abilify Maintena, Alkermes’ Aristada, and generics). An agency drug safety communication says that the uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. “These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized,” the notice says.

FDA says that although pathological gambling is listed as a reported side effect in the current drug labels, the description does not entirely reflect the nature of the risk that the agency identified. Thus, it says, new warnings about all of the compulsive behaviors are being added to the drug labels and Medication Guides.

The notice says that a search of the FDA Adverse Event Reporting System database and the medical literature in the 13 years since Abilify was first approved identified 184 case reports in which there was an association between aripiprazole use and impulse-control problems. There were 167 U.S. cases involving adults and children, with pathological gambling being the most common problem (164 cases).

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