FDA Creates One-Stop Drug Safety Page

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 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, locations, and useful phone numbers;
  • Drug-specific safety information, including safety sheets with the latest information about the drug as well as related 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 FDA through its MedWatch program;
  • Consumer articles on drug safety; and
  • FDA's response to the Institute of Medicine's 2006 report on the future of drug safety.

"By placing Web links to these up-to-date resources on a single page, we're helping consumers and health care professionals find drug safety information faster and easier," said Paul Seligman, M.D., M.P.H., associate director of Safety Policy and Communication in the FDA's Center for Drug Evaluation and Research. "This type of communication is aimed at helping consumers and health care professionals make well-informed decisions about medication use."

Establishing such a Web page is one of the requirements of the Food and Drug Administration Amendments Act of 2007, and is among FDA's many efforts to address the safe use of drugs throughout their lifecycle.

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