Drugs

FDA Denies Makena Withdrawal Petition

FDA has denied a 3/19 petition submitted by Escher Fund for Autism asking it to withdraw approval of 17-alpha hydroxyprogesterone caproate (17-HPC), including Amag Pharmaceuticals’ Makena, as a drug used in pregnancy, pending assessments of potential deleterious effects on the fetal germline. The denial letter says the petitioner supported the request by explaining the pharmacology of 17-HPC and its “hormone signal-disrupting properties,” the history of using 17-HPC in obstetric practice, and by stating that fetal germlines are vulnerable to epimutation caused by hormone signal disrupters such as 17-HPC. It says the petition focused on the relationship between use of 17-HPC during pregnancy and autism and related neurodevelopmental abnormalities in subsequent generations.

The letter notes that FDA will withdraw approval of a drug if new evidence shows that the drug is not safe, or not shown to be safe, under the conditions of use described in the approved labeling. “Nothing in the petition (or any of the subsequent comments submitted by the petitioner) provides a basis for FDA to change its prior finding that Makena (17-HPC) is safe and effective for its approved indication,” the agency declares…. “FDA will continue to monitor available evidence of safety concerns associated with use of 17-HPC and other drugs indicated for use in pregnancy, including information concerning the epigenic effects of the products we regulate and, if warranted, FDA will take appropriate regulatory action to protect the public health.”

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