Drugs

FDA Orders Cough Medicine Labeling Changes

FDA is requiring labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children under age 18. An agency news release says the “serious risks of these medicines outweigh their potential benefits in this population.”

After the safety labeling changes are made, the agency says, the products will no longer be indicated for use to treat cough in any pediatric population and will be labeled only for use in adults age 18 and older. The labeling also is being updated with additional adult use safety information, including a Boxed Warning about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing than can result from exposure to codeine or hydrocodone.

The required labeling changes are based on an extensive review of available data and expert advice shared at meeting to explore the pediatric use of opioid-containing cough and cold products, the release says. They expand the pediatric indication put in place last year when FDA required addition of a Contraindication saying that codeine should not be used to treat pain or cough in children younger than 12 due to a specific risk of ultra-rapid metabolism in certain patients.

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