Drugs

Compounded Hormone Therapies Have Risks: National Academies

At the request of FDA, the National Academies of Science, Engineering, and Medicine (NASEM) has conducted an independent assessment and evaluation of the available scientific evidence on the safety and effectiveness of compounded bioidentical hormone therapy (cBHT) products. NASEM concluded that due to a lack of high-quality clinical evidence and minimal oversight of cBHT, their widespread use poses a public health concern.

The NASEM report (available for purchase or as a free PDF) says “there is a dearth of evidence to support many of the marketed claims for the clinical utility of cBHT as a treatment of menopausal and male hypogonadism symptoms. Based on its examination of its clinical utility, the committee recommends restricted use of cBHT, assessments of their difficulty to compound, and additional education, oversight, and research.”

The report makes these recommendations:

restrict the use of cBHT preparations;
review select bioidentical hormone therapies and dosage forms as candidates for FDA’s Difficult to Compound list;
improve education for prescribers and pharmacists who market, prescribe, compound, and dispense compounded cBHT preparations;
implement additional federal and state oversight to better address public health and clinical concerns about the safety and effectiveness of cBHTs; collect and disclose conflicts of interest; and
strengthen and expand the evidence base on the safety, effectiveness, and use of compounded cBHT preparations.

FDA says it is evaluating the NASEM report and recommendations to determine next steps.

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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