Drugs

FDA Reviewing Post-market Safety of Parkinson’s Drug

FDA says it is conducting a post-marketing safety evaluation of Acadia Pharmaceuticals’ Parkinson’s drug Nuplazid (pimavanserin) based on safety reports, including 700 of those where a patient on the therapy died. The agency told CNN that the reports are difficult to attribute causality from Nuplazid because they typically involve elderly patients with an advanced-stage of Parkinson’s who suffered from other medical conditions and often took other drugs that could have increased the risk of death.

The safety evaluation was revealed after FDA commissioner Scott Gottlieb was questioned at a House appropriations hearing (see earlier story) about the drug’s safety by Rep. Rosa De Lauro (D-CT). She expressed concern because the company is seeking expanded approval for the drug, asking what it takes “for a drug like this to be taken off the market... and how many people have to die.”

Gottlieb declined to discuss any product-specific information other than to say “that there is great care taken across the medical product continuum and trying to balance risk and benefit relative to the medical condition in which we are trying to address. And when you get into issues of unmet medical needs there is the case that there is a higher tolerance for risk as long as the patients are properly informed of what the risks are.” He assured De Lauro that he will go back to the agency and “take another look at it.”

FDA told CNN that the new evaluation was based on a number of factors but wouldn’t say what those factors were. In general, the agency said it identifies “potential signals of serious risk/new safety information” in part by using adverse event data and that it is not suggesting physicians stop prescribing the drug while the evaluation is taking place.

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

Read more

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