Drugs

FDA Approves, Denies Xeloda Labeling Change Petition

FDA has approved in part and denied in part petitions filed by Ken Suprenant, a Michigan man whose wife died from rare adverse effects of chemotherapy, asking that the agency revise prescribing information for fluorouracil injection and Xeloda (capecitabine) to clarify the risk of severe toxic reactions in patients with impaired dihydropyrimidine dehydrogenase (DPD) activity. The petitions also contended that prescreening patients for DPD deficiency and proper dose management of the products could effectively reduce the risk of severe toxic and fatal reactions.

The agency letter says that changes to Xeloda prescribing information were approved 3/20/15 and changes to fluorouracil prescribing information were approved as of 7/29, the date of the petition response. “Although the changes do not include the prescreening and dose management provisions you requested,” it says, “they do clarify the risk of severe toxic reactions in patients with impaired DPD activity as you sought.”

FDA says that existing DPD screening tests are unreliable and the agency is concerned that adding a contraindication that would rely on such testing could result in an effective drug being withheld from patients who could tolerate and benefit from it. It also says that the potential benefit of fluorouracil treatment may make the risk of adverse reactions acceptable for some patients with impaired DPD activity and thus a blanket contraindication would not be appropriate.

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