Drugs

Increased Death Risk Seen With Takeda’s Uloric: FDA

An FDA drug safety review has concluded that an increased risk of death exists with Takeda’s Uloric (febuxostat) compared to another gout medicine, allopurinol. The conclusion is based on results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric, an agency notice says.

Last month, a joint meeting of the FDA Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 19 to 2 that based on its benefit-to-risk profile there is a patient population with gout that exists for Uloric as first-line treatment for hyperuricemia, despite concerns about cardiac deaths. Panel members at the 1/11 meeting discussed the drug’s cardiovascular safety. An agency briefing document released in advance of the meeting says Uloric was approved 2/2009 following three review cycles. It was rejected twice due to concerns involving cardiovascular safety and death. One of the conditions of its approval was a post-marketing safety trial (CARES trial) focused on cardiovascular risk.

FDA’s safety review has also led to an update to Uloric’s prescribing information to require a Boxed Warning and a new patient Medication Guide. “We are also limiting the approved use of Uloric to certain patients who are not treated effectively or experience severe side effects with allopurinol,” the agency says.

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