Drugs

Mixed Social Media Use of Drug Safety Communications

Researchers say that an initial drug safety communication on Sanofi-Aventis’ Ambien (zolpidem) issued by FDA 1/10/13 received significant social media uptake online, while a second communication on 5/14/13 showed almost no social media use. The study, reported in JMIR Public Health and Surveillance, looked at dissemination of the two drug safety communications through Twitter, Facebook, Google searches, and Wikipedia.

“Social media may provide a timely, singular update about changes to important prescribing information, but social media discussions are generally short-lived, while information on the proper use of a medicine needs to be available consistently,” the study says. “Future strategies for using social media should be based on a more detailed understanding of user profiles and preferences. FDA may develop multiple approaches to disseminating drug safety communication messages, including posting the same information multiple times, because a single post may often be overlooked by followers.”

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