FDA action related to medication safety and reliability, June 2007
Briefs of FDA actions related to medication safety and reliability (ie, boxed warnings, dear healthcare provider letters)
Key Points
FDA has requested that manufacturers of all antidepressant medications update the existing boxed warning on product labels to include warnings regarding increased risks of suicidal thinking and behavior (suicidality) in young adults aged 18 to 24 years during initial treatment (usually during the first 1–2 months). This updated warning will include the information that no increased risk of suicidality has been observed in adults aged >24 years, and adults aged ≥65 years have a decreased risk of suicidality. This updated boxed warning applies to the entire category of antidepressants.
Acorda Therapeutics and FDA have notified healthcare professionals of changes to the labeling for tizanidine tablets and capsules (Zanaflex). The product labeling has been updated to state that coadministration of tizanidine with other ciprofloxacin (CYP1A2) inhibitors, including zileuton, other fluoroquinolones, antiarrhythmics, cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine, should be avoided.
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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Navitus to Offer Unbranded Stelara Biosimilar, Remove Stelara from Formulary
March 13th 2025Lumicera Health Services, Navitus’ specialty pharmacy, has made a deal with Teva to offer an unbranded biosimilar that they estimate will save $112,000 and $336,000 per patient per year. Navitus will remove Stelara from formulary on July 1, 2025.
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