Drugs

Appeals Court Affirms Dismissal of Lipitor Diabetes Case

The 2^nd Circuit Court of Appeals has upheld a New York federal court’s determination that a suit accusing Pfizer of failing to adequately warn that its cholesterol drug Lipitor could cause diabetes was preempted by federal law. The appeals court summary order says the decision was based on “substantially the reasons stated by the district court.”

Reuters reports the 2019 case is one of many filed around the U.S. alleging that Lipitor can cause diabetes. Most of the cases were consolidated in multidistrict litigation that was dismissed in 2017 after the plaintiffs’ experts were excluded, the news service says.

In the 2^nd Circuit case, the plaintiffs — patients who took Lipitor and their spouses — focused on some 6,000 adverse event reports the company submitted to FDA of patients being diagnosed with diabetes after taking Lipitor. They said that Pfizer failed to warn of diabetes risk because the company was required to not only submit the adverse event reports but also to analyze them.

The district court held that the claims were preempted because Pfizer could not change the FDA-approved labeling without approval by the agency. It said preemption could only be overcome if Pfizer had new information linking diabetes with Lipitor that it failed to report.

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