January 2008 Safety labeling updates & new warnings: mycophenolic acid (Myfortic), varenicline (Chantix), and desmopressin
Labeling updates and warnings through January 2008 for mycophenolic acid (Myfortic), varenicline (Chantix), and desmopressin
Key Points
The boxed warning for mycophenolic acid (Myfortic, Novartis) delayed-release tablets has been updated to change the pregnancy category from C to D. The update includes information regarding the increased risks of miscarriage and congenital malformation when the agent is used during the first trimester of pregnancy.
FDA has asked healthcare providers to monitor patients taking varenicline (Chantix, Pfizer) for behavioral and mood changes, including suicidal thoughts and aggressive and erratic behavior. Patients should use caution while driving or operating machinery as drowsiness has also been reported in patients treated with varenicline.
FDA has requested that the label for desmopressin (DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) be updated to include information regarding the risk of severe hyponatremia and seizures that can result in death with use of the agent. Intranasal formulations of desmopressin should no longer be used to treat primary nocturnal enuresis (PNE) and should not be used to treat patients with hyponatremia or with a history of hyponatremia. Treatment of PNE with desmopressin tablets should be interrupted if a patient has an acute illness that could lead to fluid and/or electrolyte imbalance. Caution should be used with all formulations of desmopressin when treating patients at risk for water intoxication with hyponatremia.
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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