This listing includes accelerated approvals (AAs) for non-malignant hematological, neurological, and other disorder indications that have postmarketing requirement(s) that have been subsequently withdrawn, and are therefore, no longer FDA-approved. […]

Summary Company Announcement Date: February 20, 2025 FDA Publish Date: February 20, 2025 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and […]

Español Drug Safety Podcast Drug Safety Communication (PDF – 52KB) 01-14-2020  FDA Drug Safety Communication The U.S. Food and Drug Administration (FDA) is alerting the public that results […]

FDA identified 10 cases of constipation that progressed to serious complications with clozapine use reported in the FDA Adverse Event Reporting System (FAERS) database from July […]

We reviewed data from the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients – Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) clinical trial. […]

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 […]