Understanding the Risks of Prescription Drugs

Order Our Drug Profile


For any target drug you can get our innovative Adverse Event Profile that provides a crisp analysis of the Profile CoverFDA MedWatch reports in the agency's AERS system.

The package includes a database with all the reports and a special viewer to select a group of cases of interest.

Much of the new information about the adverse effects of any prescription drug is derived from this important data source.

The profile is packed with informative charts and graphs that map out trends over time, portray the patient profile and help understand the kinds of adverse events reported most frequently.

For full details and illustrations

 

We conduct research, publish reports and undertake consulting assignments focusing on the risks of prescription drugs. Thomas J. Moore, author of numerous books, articles and scholarly studies on drug safety, founded the firm in 2003.

The prinicipal focus is on drug adverse event reports and post market surveillance from the United States and abroad, and on the analysis of clinical trials data about the risks and benefits of drugs and biological products. Contact us...

 

 

 

Safety Watch

Watch this space for the latest safety headlines.

New FDA Warning on Antidepressant Drugs

Finally the Food and Drug Administration has issued a new warning that people taking antidepressant drugs should be monitored for a wide spectrum of potentially dangerous changes in mood or personality. These changes range from sucidical and hostile behaviors to mania and extreme euphoria.

Drug Safety Research has completed two new studies about the safety of antidepressant drugs. The first study reveals that use in children doubled in just four years, and identifies new safety concerns. The second study examines adverse event reports about potentially dangerous personaly changes in both children and adults. For copies of the full reports, visit our our Library

FDA Enforcement Declines

A new report from the Democratic staff of the House Committee on Government Reform concluded that FDA is moving more slowly and less often against drug companies for violating drug advertising regulations.

The committee also sent the FDA a collection of false or misleading advertisments which it said should have warranted more forceful and prompt action.

Download a copy from our Library.

 

Reports & Resources

Download copies or use links to useful documents about drug safety. Examples from our library:

  • Guide to interpreting adverse event reports
  • Reported adverse events in children < 2 years
  • Limited efficacy of antidepressant drugs
  • Getting information from the FDA fast
  • MedWatch reporting form