Drugs

Takeda Gout Drug has Higher Cardiovascular Risks: FDA

An FDA drug safety alert says that Takeda’s gout drug Uloric (febuxostat) may have an increased risk of heart-related death when compared to allopurinol (Mylan’s Aloprim and Casper Pharma’s Zyloprim). This is the preliminary finding from an FDA-required safety study conducted by Takeda. “Once the final results from the manufacturer are received, FDA will conduct a comprehensive review and will update the public with any new information,” an agency notice says.

Febuxostat already carries a Warning and Precaution about cardiovascular events because the clinical trials conducted before its 2009 approval showed a higher rate of heart-related problems in patients treated with febuxostat compared to allopurinol. “These problems included heart attacks, strokes, and heart-related deaths,” FDA says.

The agency’s current recommendation based on the preliminary results is for health care professionals to consider the safety information when deciding whether to prescribe or continue patients on febuxostat.

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