Drugs

Lack of Evidence for Compounded Pain Creams: Report

A new report from the National Academies of Sciences, Engineering, and Medicine says there is a lack of scientific evidence to support the safety or effectiveness of compounded topical pain creams. The report, “Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use,” recommends changes such as improving federal and state oversight of safety measures, data collection, and surveillance; and training and education for pharmacists and clinicians who compound.

The committee that wrote the report reviewed 20 active pharmaceutical ingredients (APIs) in compounded topical pain creams meant for application to healthy, intact skin. It found that of the 20 APIs reviewed, only three — doxepin, lidocaine, and naproxen — showed potential evidence of effectiveness.

The report recommends that the National Association of Boards of Pharmacy (NAPB) require compounding pharmacies to provide a standardized insert for all compounded topical pain creams clearly outlining how much should be used, the APIs and inactive ingredients, and the potential adverse effects. It also says that the association should require 503A compounding pharmacies to report adverse events at the state level and to FDA MedWatch.

It calls on FDA and a global standards-setting organization such as the U.S. Pharmacopeia to collaboratively develop standard processes for testing APIs and inactive ingredients commonly used in compounded topical pain creams.

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