New Regulations on Testing Drug Side Effects for Suicidal Thoughts

January 25, 2008

After the complaints involving suicidal thoughts while on drugs like Chantix, Ritalin, anti-depressants, Rimonbant, Taranabant and various other pharmaceutical drugs, the Food and Drug Administration has decided to require suicide studies in drug trials before an experimental medication can go to market.

Researchers at Columbia University have developed a questionnaire to assess suicidal thought tendencies and suicidal behavior of patients. The FDA is now requiring that all pharmaceutical companies adopt the questionnaire as part of their clinical drug trial methodology.

The new questionnaire includes questions like:
- Have you done anything to harm yourself because you wanted to end your life?
- Have you worked out the details of how to kill yourself?

This comes after decades of ignoring psychiatric side effects of experimental medicines, and thousands of complaints involving drugs already on the market. In fact, some drugs cause depression so regularly that physicians actually prescribe antidepressants to go with them.

This is one of the biggest changes to drug development regulations in the last sixteen years. However, critics say the questionnaire may not be going far enough. What is to happen with a drug that clearly makes people depressed, but not “suicidal” – do we let it go to market anyway?

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