Drug Safety Communications
This webpage was developed to provide the public with easy access to important drug safety information. The webpage contains the most recent Drug Safety Communications from FDA as well as links for Early Communications, Follow-Up Early Communications, Information for Healthcare Professional sheets, and Public Health Advisories issued prior to January 29th, 2010. You can also find drug specific information using the Index to Drug-Specific Information.
Starting July 18, 2011, you can find Spanish language versions of the Drug Safety Communications on our Drug Safety Communications in Spanish page.
El 18 de julio de 2011, se pueden encontrar versiones en español de las Comunicaciones de Seguridad de Medicamentos en nuestra Comunicaciones de la FDA sobre la seguridad de los medicamentos en español de la página.
Current Drug Safety Communications
FDA Drug Safety Communication: FDA approves label changes for zolpidem products, including new dosing and a recommendation to avoid driving the day after Ambien CR use
- Valproate Anti-seizure Products Contraindicated for Migraine Prevention in Pregnant Women due to Decreased IQ Scores in Exposed Children
- FDA warns about potential medication errors resulting from confusion regarding nonproprietary name for breast cancer drug Kadcyla (ado-trastuzumab emtansine)
- FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death