Drugs

Group Sues FDA Over Petition Inaction

Public Citizen has filed a lawsuit in DC federal court against FDA over a 2016 citizen petition that the agency has not acted on that sought a boxed warning on dopamine agonist medications, which can allegedly cause compulsive or uncontrollable behaviors. The petition sought labeling changes to six drugs that are used in treating Parkinson’s disease and restless leg syndrome because there is an increased risk of impulse control problems that can lead to pathological gambling, hypersexuality, and compulsive shopping or eating, the advocacy group said. The six drugs are U.S. Worldmeds’ Apokyn (apomorphine), Veroscience’s Cycloset (bromocriptine), Par’s Cabergoline (cabergoline), Boehringer Ingelheim’s Mirapex (pramipexole), GlaxoSmithKline’s Requip (ropinirole), and UCB’s Neupro (rotigotine).

The petition said that studies have shown that as many as 20% of patients taking a dopamine agonist may develop certain impulse control problems and compulsive behaviors. It describes many anonymous examples from the medical literature of patients whose lives were affected by the drugs.

Public Citizen’s lawsuit is seeking a declaration that the agency violated the Administrative Procedure Act by failing to act on the petition after three years. “The current warnings found in the product labels are far too obscure and weak and do not adequately warn prescribers and patients about these serious risks,” the group said. “The FDA needs to act now before these adverse effects devastate more patients’ lives.”

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