FDA action related to medication safety and reliability, October 2007
Briefs of FDA actions related to medication safety and reliability
Key Points
At a joint meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, panel members recommended that marketing authorization for aprotinin injection (Trasylol, Bayer) should be continued. The committees convened to discuss the safety issues associated with aprotinin, including the risk of renal failure and dysfunction, death, heart attack, and stroke. Although the committees recommended that this agent should remain on the market, panel members also recommended that product labeling for aprotinin should be revised to emphasize the risks of off-label use of this drug. The committee members also suggested that Bayer should conduct additional clinical trials to assess the risks and benefits of this agent.
At a joint meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, panel members recommended that labeling for erythropoiesis-stimulating agents (ESAs) should not be changed to state that the target hemoglobin level should not exceed 11 g/dL when ESAs are administered for the treatment of anemia in patients with chronic renal failure, whether or not patients are on dialysis.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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