Drugs

ISMP Challenges FDA Nuplazid Evaluation

The Institute for Safe Medication Practices (ISMP) says an FDA safety evaluation of Acadia Pharmaceuticals’ Parkinson’s drug Nuplazid (pimavanserin) that found no “new or unexpected” risks not covered in the labeling still leaves questions about the drug’s safety and efficacy unanswered. A CNN report says ISMP does not believe the FDA “reassurance” was warranted.

FDA and Acadia say the number of reported deaths attributed to Nuplazid is high due to an already sick population and the company’s distribution system through a network of specialty pharmacies that makes it more likely the company would learn of deaths from both patients and caregivers and then submit the information to FDA.

The agency declined to comment to CNN on the ISMP report, saying that “in general, FDA does not comment on individual studies or reports, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect the public health.”

Acadia said the report’s findings were “severe mischaracterizations and conjectures about the safety and efficacy of Nuplazid” and said the report did not give a complete characterization of the drug’s benefit/risk profile.

ISMP said it stood by the report, terming it a “scientific report that is based on published data, FDA documents, and experience of our expert project team…. The source documents and information we cite provide abundant support for our findings of fact and conclusions about the drug’s risks and benefits.”

The drug, which is approved only to treat Parkinson’s disease psychosis, carries a Boxed Warning for an increased mortality in elderly patients with dementia-related psychosis. ISMP says it believes that the Boxed Warning is not clear and should be revised to say that treatment with Nuplazid might result in a substantially increased risk of death, similar to the warnings for other antipsychotics used in elderly patients with psychosis.

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