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.
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