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
- 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
- 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
- Regulations and guidance documents;
- Consumer information about using medications safely and disposing of unused
- Instructions how to report problems to the FDA through its MedWatch
- 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.