Drugs

Petition Seeks Box Warnings on Opioids and Benzodiazepines

Baltimore City Health Department and Rhode Island Department of Health have begun a petition at change.org urging FDA to require black box warnings on opioids and benzodiazepines to warn about overdose risks when used concurrently. The health departments say the products require clear warnings to educate healthcare providers and patients about the dangers of mixing the two drugs.

“Biological data indicate that these two drug classes interact in the brain to place patients at increased risk of respiratory depression and fatal overdose,” the petition says. “Epidemiological studies show that nearly one in three unintentional overdose deaths from prescription opioids also involve benzodiazepines. Nonetheless, more patients than ever before are being prescribed both opioids and benzodiazepines, and more are running into serious problems from combined use. Treatment admissions for substance use disorders involving both classes of medications at the same time in the United States increased by 569% from 2000 to 2010.”

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