In accordance with the Food and Drug Administration (FDA) Amendments Act of 2007, the federal agency has just launched a new web page devoted entirely to drug safety data that both the public and the medical community can access.  The object of the page is to help people, from professional to patient, make better informed decisions regarding medications at every step of the supply chain.

The web page, www.fda.gov/cder/drugSafety.htm, features links to a wide array of data on drugs in question, including:

• Drug labels written for the professional as well as the label the patient sees on a prescription container.  Also supplied is the data included as package inserts that go to the consumer.
• The Risk Evaluation and Mitigation Strategy (REMS) is supplied for all drugs for which such a strategy might better ensure the patient gains the benefits in a way that best offsets the risks.
• A database with search capabilities that accesses the post-market study data for a given drug.  Post-market studies provide additional information to the FDA after the drug reaches the market but questions as to its efficacy, optimal use, or its safety arise.
• A separate, searchable database that links to all clinical studies associated with a specific drug.  At www.clinicaltrials.gov, each entry includes the trial’s purpose, its participants, study sites, and contact information, including telephone numbers.
• Safety information specific to a given drug, including the latest safety and fact sheets, FDA-issued press announcements, and podcasts describing the drug’s safety.
• Quarterly reports on drugs under continued investigation because of information gathered from the FDA Adverse Event Reporting System (AERS).
• Copies of all warning letters, safety alerts, recalls, voluntary withdrawals from the market, and import alerts pertaining to a specific drug.
• Documents that define guidance procedures and regulations.
• Consumer-targeted information about taking a specific medication as effectively and safely as possible and how to best dispose of any unused prescriptions.
• Articles on drug safety written with the consumer in mind.
• The FDA response on the future of drug safety as questioned by the Institute of Medicine’s report for 2006.

Source: FDA