Drugs
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
- Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy
2/20/2013 - Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist)
1/10/2013 - Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valves
12/19/2012