Drugs

Group Petitions FDA to Ban Cesium Chloride from Compounding

Advocacy group Public Citizen has petitioned FDA to add cesium chloride to its 503A Category 2 list of bulk drug substances identified by the agency as presenting a significant safety risk in drug compounding. The group says FDA has dragged its feet in adding the drug to the listing, noting that an advisory committee meeting and agency reviewers determined more than 18 months ago that cesium chloride presents “serious safety concerns” and should be included on the 503A bulks list. “The failure to take such action represents an unreasonable delay that has threatened patient safety,” the group says in its petition.

On 9/30/2014, the American Association of Naturopathic Physicians, Alliance for Natural Health USA, Integrative Medicine Consortium, and McGuff Compounding Pharmacy Services nominated cesium chloride for inclusion on the 503A bulks list for use in combination with other natural substances in treating individuals with numerous types of cancer, “by a presumed alkalinizing effect,” Public Citizen says. The proposed route of administration for the drug is intravenous infusion. It notes there is no applicable monograph for cesium chloride, and it is not a component of any FDA-approved drug product.

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