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.
您可以在我们 药品安全通讯的 中文网页上找到中文版的 药品安全通讯。
Current Drug Safety Communications
- 11/02/2021 FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury
- 9/01/2021 FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions
- 7/20/2021 FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins
- 6/16/2021 FDA warns that vapors from alcohol-based hand sanitizers can have side effects
- 5/26/2021 Due to risk of serious liver injury, FDA restricts use of Ocaliva (obeticholic acid) in primary biliary cholangitis (PBC) patients with advanced cirrhosis
Previous Drug Safety Communications
- 2021 Drug Safety Communications
- 2020 Drug Safety Communications
- 2019 Drug Safety Communications
- 2018 Drug Safety Communications
- 2017 Drug Safety Communications
- 2016 Drug Safety Communications
- 2015 Drug Safety Communications
- 2014 Drug Safety Communications
- 2013 Drug Safety Communications
- 2012 Drug Safety Communications
- 2011 Drug Safety Communications
- 2010 Drug Safety Communications
Resources For You
- CDER Conversation: CDER's Drug Safety Communications: Ensuring postmarket safety
- Index to Drug-Specific Information