Boxed warning about tardive dyskinesia added to metoclopramide label
FDA has stated that manufacturers of metoclopramide must add a boxed warning to their drug labels regarding the risk of tardive dyskinesia with long-term or high-dose use of this agent.
FDA has stated that manufacturers of metoclopramide must add a boxed warning to their drug labels regarding the risk of tardive dyskinesia with long-term or high-dose use of this agent.
Metoclopramide is approved for the short-term treatment of gastroesophageal reflux disease (GERD) in patients who have not responded to other treatments and for the treatment of diabetic gastroparesis. This agent is available in tablet, oral solution, and injection formulations.
FDA has also announced that metoclopramide manufacturers must implement a risk evaluation and mitigation strategy (REMS) to ensure that patients are aware of the risk of tardive dyskinesia associated with this medication.
Metoclopramide was the subject of a recent California court case in which the court found Wyeth accountable for harms caused (in the form of tardive dyskinesia) in a patient who was treated with generic metoclopramide for nearly 4 years (see "California court: Wyeth accountable for harms caused by generic metoclopramide").
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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