Drugs

Prevent Makena Compounding: Public Citizen

Public Citizen has petitioned FDA to promptly add Covis Pharma’s Makena (hydroxyprogesterone caproate) and its generics to the official list of drugs withdrawn or removed from the market because they were deemed unsafe or ineffective. A statement (contains a link to the petition) says the action is necessary to prevent pharmacy compounding of the newly-banned drug. Makena was indicated for the prevention of preterm birth.

“To protect patients, FDA must move swiftly to take regulatory action that would prohibit pharmacy compounding of the now banned hydroxyprogesterone for prevention of preterm birth,” says Public Citizen Health Research Group director Michael Carome. “Without such action, the numerous obstetricians and fetal medicine physicians who opposed FDA’s proposal to withdraw approval of Makena will likely continue to prescribe compounded versions of this ineffective and potentially dangerous drug to pregnant women.”

Carome said it was important to acknowledge that when FDA commissioner Robert Califf and chief scientist Namandjé Bumpus approved withdrawing Makena from the market, they said the current lack of data supporting the drug’s effectiveness implicated compounded products as well as the branded and generic versions.

Joining Public Citizen as a co-petitioner was Adam Urato, chief of maternal-fetal medicine at the MetroWest medical center in Framingham, MA.

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