FDA drug safety updates: ADZYNMA boxed warning, Tazverik withdrawal, Tavneos liver injury
Key Questions
What new FDA warnings apply to ADZYNMA?
Takeda's ADZYNMA received a boxed warning following a fatal antibody-related case. This is a postmarket safety signal requiring close patient monitoring. Healthcare providers should educate patients on risks.
Why was Tazverik withdrawn from the market?
Tazverik (tazemetostat) was withdrawn due to a 5% rate of second malignancies in patients. The decision reflects emerging safety data on cancer risks. Alternative treatments should be discussed with physicians.
What label update occurred for Tavneos?
Tavneos (avacopan) labels were updated to include warnings for VBDS liver injury. This follows postmarket reports of serious hepatic events. Expired levonorgestrel products also carry separate FDA cautions.
Takeda's ADZYNMA gets FDA boxed warning after fatal antibody case; Tazverik (tazemetostat) withdrawn for 5% second malignancies; Tavneos (avacopan) label updated for VBDS liver injury. Also expired levonorgestrel warning. These are new postmarket safety signals requiring monitoring and patient education.