Drugs

FDA Gabapentinoid Safety Communication

FDA says that serious breathing difficulties may occur in patients using gabapentin (Pfizer's Neurontin, Assertio’s Gralise, Arbor’s Horizant) or pregabalin (Pfizer’s Lyrica and Lyrica CR) who have respiratory risk factors. In a drug safety communication, the agency said its evaluation showed that the use of the gabapentinoids has been growing for prescribed medical use, as well as misuse and abuse.

“Gabapentinoids are often being combined with central nervous system depressants, which increases the risk of respiratory depression,” the notice said. “Central nervous system depressants include opioids, anti-anxiety medicines, antidepressants, and antihistamines. There is less evidence supporting the risk of serious breathing difficulties in healthy individuals taking gabapentinoids alone.”

As a result of its findings, the agency said it is requiring that new warnings about the risk of respiratory depression be added to gabapentinoid labeling. It also is requiring the drugs’ manufacturers to conduct clinical trials to further evaluate the abuse potential, particularly in combination with opioids, because of the increasing misuse and abuse of the products together. Special attention will be paid to the respiratory depressant effects during the abuse potential evaluation, FDA said.

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

Read more

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