Drugs

FDA Warns of Medication-Assisted Treatment Drug Risks

FDA says that opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other central nervous system depressants. An agency drug safety communication says the “combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction can outweigh these risks. Careful medication management by healthcare professionals can reduce these risks.”

The notice says FDA is requiring that the information be added to the buprenorphine and methadone drug labels with detailed recommendations for minimizing use of medication-assisted treatment drugs and benzodiazepines together.

In a statement released with the safety communication, FDA commissioner Scott Gottlieb says reducing the number of Americans addicted to opioids and cutting the rate of new addiction is one of the agency’s highest priorities. “We must do everything possible to address the staggering human toll caused by opioid use disorders, and ensuring patients receive proper treatment for both addiction and coexisting mental health conditions is a critical step in that effort,” he 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