Drugs

Fecal Microbiota for Transplant Safety Alert

FDA is alerting healthcare providers and patients to the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT). An agency notice says it is aware of infections caused by enteropathogenic Escherichia coli and Shigatoxin-producing Escherichia coli that have occurred following investigational use of fecal microbiota for transplantation. FDA says it suspects the infections are due to transmission of the pathogenic organisms from FMT products supplied by a stool bank company based in the U.S.

The notice says that a 7/2013 guidance indicated the agency would exercise enforcement discretion under limited conditions regarding the IND requirements for using FMT products to treat C. difficile infections in patients that have not responded to standard therapies. The guidance said that enforcement discretion would be exercised provided the treating doctor obtains adequate consent for the use of FMT from the patient or authorized representative.

The agency says patients considering FMT to treat C. difficile infection should talk with their healthcare provider about the associated risks.

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