We searched the medical literature and the FDA Adverse Event Reporting System (FAERS) for cases of oligohydramnios or neonatal renal dysfunction associated with nonsteroidal anti-inflammatory drug […]

The FDA has issued new information about Xeljanz, Xeljanz XR (tofacitinib) and other Janus kinase (JAK) inhibitors. See the FDA Drug Safety Communication issued on 9-1-2021. […]

FDA reviewed data from case series and prospective and retrospective observational cohort studies over decades of use of statins in pregnant women.1-15 Multiple larger, well-designed, and […]

On This Page Date: September 9, 2024 Time: 9:00 a.m. – 4:00 p.m. ET What is an advisory committee? Advisory committees provide independent expert advice to […]

Español 药物安全通讯 Drug Safety Communication (PDF – 62 KB) 2-3-2022 FDA Drug Safety Communication The U.S. Food and Drug Administration (FDA) is investigating a possible increased risk […]

Copiktra was approved in 2018 based on the benefit-risk evaluation of data available at the time from the DUO trial for patients with relapsed or refractory […]

Patients should stop taking glatiramer acetate and seek immediate medical attention by going to an emergency room or calling 911 if you experience symptoms of an […]

Image Español Whether you’re settling into your 60s or heading into your 90s, be careful when taking medicines, herbal preparations and supplements. Why the special concern? […]

Image Español ZZZZZ. Remember sleeping through the night? Not lately? If you’re lying awake night after night, unable to sleep, you may want to talk to […]