New FDA Site Gives Public More Information About Drug Safety

On June 16, the Food and Drug Administration (FDA) launched a new web site to provide safety information on recently released drugs to consumers and health care professionals.

The site, Postmarketing Drug Safety Evaluations, includes safety data summaries collected on products that have been on the market for a minimum of 18 months, or used by 10,000 patients, whichever occurs later. The summaries provide information on newly discovered side effects and other safety risks as well as what steps the FDA is taking to address these issues and protect consumers.

During the first day of the site's launch, the FDA presented summaries on 26 drugs originally released between September 2007 and January 2008 and plans to update the summaries on a quarterly basis.

The FDA's decision to make this information available to the public is due in part to recent criticism that the agency has not been adequately monitoring the safety of drugs once approved for use.

Critics point out that monitoring drugs after their release is vital because of the potential for new safety risks to become apparent once the drug is exposed to a larger, more diverse population. For example, while children, the elderly and pregnant women usually are excluded from drug clinical trials, individuals from these populations may take the drug once it is approved for use. As a result, previously unknown side effects may occur, or adverse reactions that occurred infrequently during trials may begin occurring more regularly, requiring the FDA to take action.

Additionally, once a drug receives FDA approval, individuals taking other medications may also take the drug, creating the potential for dangerous drug interactions not identified during the clinical trials.

The information included in the summaries comes from a variety of sources, including reports issued by the drug's manufacturer, information from medical literature and data from on-going studies. Relevant information from reports made by consumers, physicians and other health care providers to the FDA's Adverse Event Reporting System (AERS) also may be included in the summaries.

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