We reviewed case reports submitted to FDA, conducted an observational study using data from FDA’s Sentinel System, and reviewed observational and animal studies in the published […]

The FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and […]

To reduce the risk of death from opioid overdose, the U.S. Food and Drug Administration (FDA) is making the following recommendations about the opioid reversal medicine, […]

Español Drug Safety Podcast Drug Safety Communication (PDF – 58KB) 8-26-2020 FDA Drug Safety Communication Based on a U.S. Food and Drug Administration (FDA) review of new […]

We reviewed postmarketing databases and the published literature on the use of benzodiazepines and associated abuse, misuse, addiction, and physical dependence. In 2019, an estimated 92 […]

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. […]