FDA Consolidates Patient & Healthcare Professional Drug Safety Information in One Access Point

Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration’s Web site to find a wide variety of safety information about prescription drugs. The Web page,www.fda.gov/cder/drugSafety.htm, provides links to information in these categories:
  • Drug labeling, including patient labeling, professional labeling, and patient package inserts;
  • Drugs that have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that their benefits outweigh their risks;
  • A searchable database of postmarket studies that are required from, or agreed to by, drug companies to provide the FDA with additional information about a drug’s safety, efficacy, or optimal use;
  • Clinicaltrials.gov, a searchable database of clinical trials, including information about each trial’s purpose, who may participate, and useful phone numbers;
  • Drug-specific safety information, including safety sheets with the latest information about the drug and FDA press announcements, fact sheets, and drug safety podcasts;
  • Quarterly reports that list certain drugs that are being evaluated for potential safety issues, based on a review of information in the FDA’s Adverse Event Reporting System (AERS);
  • Warning Letters, Import Alerts, Recalls, Market Withdrawals, and Safety Alerts;
  • Regulations and guidance documents;
  • Consumer information about using medications safely and disposing of unused medicines;
  • Instructions how to report problems to the FDA through its MedWatch program;
  • Consumer articles on drug safety.
Establishing such a Web page is one of the requirements of the Food and Drug Administration Amendments Act of 2007.