• Defective Drug Side Effects

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A U.S. Food and Drug Administration panel of experts is urging the makers of at least 12 antidepressant drugs to expand their label warnings after studies indicated the medications increased the risk of suicidal behavior in a broader span of patients than was thought.

In 2004, a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs) such as Paxil and Prozac, as well as similar drugs, received “black box” warnings alerting doctors and patients that the drugs may raise the risk of suicidal behavior and attempts in young children and teenagers under 18.

Now, however, government officials want the warnings to include young adults up to the age of 25.

Antidepressants and Young Adults

New studies suggest that young adults up to 24 years of age who use SSRI drugs are two times as likely to experience suicidal thoughts or attempt suicide than those who are given a placebo.

A review of 372 FDA-conducted studies failed to show any evidence of completed suicides that can be directly linked to the drugs and the panel maintains these behaviors are relatively rare.

However, regulators did point out the consistent trend in such behaviors, which occur more often in younger children and taper off in young adulthood.

“There''s nothing magical about 25. It''s not like this goes away the day you turn 25,” said Marc B. Stone, MD, a medical analyzer in the FDA''s division of psychiatric products. “But the risk seems fairly flat in the 25 to 64 range and pretty steep in the 18 to 24 range. We can''t ignore it.”

In 2004, the FDA estimated that antidepressant drugs contribute to suicidal behaviors and thoughts in an additional 14 children for every 1,000 who use them. Government officials say that less than one-third as many adults under 25 face this added risk.

What Causes This Risk?

Experts believe there could be a number of factors that may explain why the drugs raise the risk of suicidal behaviors in those under 25. It''s possible that SSRI drugs prompt such activity during initial treatment, only to help ward it off as depression and other psychiatric disorders diminish.

Or some believe that younger people have a greater inclination to act impulsively or are more likely to communicate or relate their suicidal thoughts out loud.

In either case, the risks are a great cause for concern and doctors and patients should be warned in order to make informed decisions about drug use.

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