Drug Safety Information for Healthcare Professionals

 

As of January 29, 2010, FDA has transitioned to using one safety communication to provide the public with easy access to important drug safety information. These Drug Safety Communications have replaced Early Communications, Follow-Up Early Communications, Information for Healthcare Professional sheets, and Public Health Advisories. They are written in an easy-to-read, interactive format so that the public can access the information that is relevant to them. FDA has provided links on the new Drug Safety Communications page to the archived safety communications.

 

Types of Safety Announcements

• Early Communication About an Ongoing Safety Review: This type of communication is part of FDA's effort to communicate early with the public when the agency is still evaluating data and has not reached a conclusion. FDA shares information in the interest of informing doctors and patients about the issues that are under review and when FDA experts anticipate completing their review.
• Information for Health Care Professionals: Also referred to as a Healthcare Professional Information sheet, this information from FDA is for doctors, pharmacists, nurses, and other health care professionals. It contains an "alert" (a summary of the new safety information), detailed information about the safety issue, factors to consider when making treatment decisions, information for health care professionals to discuss with patients about their roles in reducing the risks from the drug, and a summary of the facts or data that serve as the basis for the information in the sheet.