FDA action related to medication safety and reliability, September 2007
Briefs of FDA actions related to medication safety and reliability
Key Points
FDA has requested that a boxed warning regarding an increased risk of heart failure be added to the product labeling for all drugs in the thiazolidinedione class. The manufacturer of rosiglitazone, rosiglitazone/glimepiride, and rosiglitazone/metformin (Avandia, Avandaryl, and Avandamet, respectively; GlaxoSmithKline) and the manufacturer of pioglitazone and pioglitazone/glimepride (Actos and Duetact, respectively; Takeda) have agreed to add the warning, which states that the drugs, which are used in conjunction with diet and exercise to improve blood sugar control in adults with type 2 diabetes, may cause or worsen heart failure in certain patients. In the warning, healthcare professionals are advised to observe patients carefully for the signs and symptoms of heart failure once drug therapy has been initiated. The warning also states that these agents should not be used in patients with serious or severe heart failure who have significant limits on their activity and who are comfortable only at rest or are confined to a bed or chair.
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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