Friday, January 25, 2008

FDA to require suicide studies

U.S. requiring suicide studies in drug trials

The drug agency's concerns are consistent with a growing body of research confirming that behavior is heavily influenced not only by genes but also by seemingly innocuous changes in body chemistry. Drugs not reaching the brain were once thought to be largely free of mental effects.
"One lesson from pharmacology is that you can see effects on emotion and cognition without the drug entering the brain if a drug leads to peripheral changes in" other chemicals that enter the brain, said Dr. Thomas Insel, director of the National Institute of Mental Health.

Some critics say that the agency's new-found focus on psychiatric side effects is long overdue.
"The list of drugs that causes psychiatric problems is a very long one," said Dr. Sidney Wolfe, director of Public Citizen's health research group.
Medicines to treat acne, hypertension, high cholesterol, swelling, heartburn, pain, bacterial infections and insomnia can all cause psychiatric problems, effects that were discovered in most cases after the drugs were approved and used in millions of patients.
Some drugs cause depression so often that doctors prescribe antidepressants prophylactically with them.

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