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Med Safety actions in brief
Briefs of FDA actions related to medication safety and reliability (ie, boxed warnings, dear healthcare provider letters)
Key Points
At FDA's request, Novartis has suspended marketing and sales of tegaserod (Zelnorm), which was approved in 2002 for the short-term treatment in women with irritable bowel syndrome whose primary symptom is constipation and in 2004 for the treatment of chronic constipation in men and women aged <65 years. New analyses of 29 clinical trials of tegaserod for a variety of gastrointestinal conditions demonstrated that tegaserod-treated patients had a statistically significantly increased risk of cardiovascular adverse events (ie, myocardial infarction, stroke, and unstable angina pectoris) compared with patients taking placebo.
At FDA's request, manufacturers of pergolide products (Permax, Valeant; generic pergolide, Par and Teva), have withdrawn their drugs from the market. This agent was originally approved in 1988 as an adjunctive therapy with levodopa for the treatment of Parkinson disease. In 2003, FDA requested that a warning regarding the risk of valvulopathy be added to the drug's label; in 2006, this warning was upgraded to a boxed warning. Two new studies have confirmed that patients taking pergolide have an increased risk of regurgitation of the mitral, tricuspid, and aortic valves of the heart.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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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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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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