Drugs

FDA Tells 21 Web Sites to Stop Selling Opioids

FDA says it has warned four more online networks with a total of 21 Web sites to stop marketing potentially dangerous, unapproved, and misbranded versions of opioids, including tramadol (Ultram). Commissioner Scott Gottlieb says in a statement that the Warning Letters sent by FDA this summer now total 13, covering more than 70 Web sites. “FDA remains resolute in our promise to continue cracking down on these networks to protect the public health,” he says. “We have more operations underway and additional actions planned.”

The statement says the illegal sale of the products is particularly concerning considering that the approved version of tramadol contains a Boxed Warning for a significant risk of serious or even life-threatening adverse effects including addiction, abuse, misuse, life-threatening respiratory depression, and neonatal opioid withdrawal syndrome.

The companies were told to respond with specific actions they are taking to address the agency’s concerns. The notice says that companies that fail to correct the violations may be subject to legal enforcement action.

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