2019 Drug Safety Communications

• FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) 12/19/2019
• FDA warns about rare but severe lung inflammation with Ibrance, Kisqali, and Verzenio for breast cancer 9/13/2019
• FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease 8/28/2019
• FDA review finds no increased risk of prostate cancer with Parkinson's disease medicines containing entacapone (Comtan, Stalevo) 8/13/2019
• FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR) 7/26/2019
• FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines 4/30/2019
• FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering 4/9/2019
• Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate 2/25/2019
• FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat) 2/21/2019