The FDA's Drug Information Website

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The FDA's Drug Information Website

An entry point into a wealth of safety information

By Elizabeth Hanink, RN, BSN, PHN
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Here’s a welcome innovation from the Food and Drug Administration. The government agency announced recently the creation of a new webpage with drug information for patients and healthcare professionals alike. Add it to your bag of useful and easily accessible resources.

The idea of a single page as an entry point to a variety of safety information is a good one. Go to, and in the middle column under Drug Safety, click on “Postmarket Drug Safety Information for Patients and Providers.” Having given it a try myself, I can say it is comprehensive and easy to use. Some information is quite technical; some clearly targets consumers. Links include the following categories, among others:

1. Labeling, including patient labels, professional labeling and package inserts

2. Drugs with Risk Evaluation and Mitigation Strategy (REMS) listings

3. A searchable database on current clinical trials, including useful phone numbers and criteria for participation

4. A collection of post-market studies of FDA-approved drugs, to provide additional information on the optimal use, safety and efficacy of drugs on the market

5. Safety information, including alerts, recalls and warning letters

6. Disposal instructions for consumers

7. Consumer articles on drug safety

8. Quarterly reports on AERS, the FDA’s Adverse Event Reporting System

9. Links to and instructions on how to use the program

This service is an effort to increase the transparency of a drug’s information and to disseminate the information throughout its lifecycle.

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