May 2 (Bloomberg) -- Antidepressant drugs, including Wyeth's top-selling Effexor,
need new warnings of the risks of suicidal thoughts and behavior among young
adults, U.S. regulators said.
The Food and Drug Administration asked the makers of 36 antidepressants to
extend an existing precaution for children and adolescents to cover people ages
18 to 24 when they first use the drugs, the agency said in a statement today.
Wyeth, Eli Lilly & Co. and other drug makers must revise their labels within 30
days.
Sales of antidepressants fell after the warning about risks in children and
adolescents was added in 2005. The FDA said today that scientific data hasn't
shown an increased danger in adults older than 24, although consumer groups have
urged the agency to broaden the warnings.
``What is magic about the cutoff of 24?'' said Sidney Wolfe, director of health
research at Public Citizen in Washington, in a telephone interview. ``It doesn't
make sense to pretend that the problem goes away once you get older.''
Americans spent $13.5 billion on antidepressants last year, according to data
compiled by IMS Health Inc., a research firm in Fairfield, Connecticut. The
medicines include Forest Laboratories Inc.'s Lexapro, Lilly's Cymbalta and
Pfizer Inc.'s Zoloft.
People currently taking prescription antidepressants should continue to use them
and consult their doctors if they have concerns, the FDA said. Depression and
other psychiatric disorders, not medicines, are the most important causes of
suicide, the agency's proposed warning emphasizes.
`Risk is Small'
``The risk is quite small,'' said Thomas Laughren, director of the FDA's
psychiatric products division, on a conference call today. Studies found that
taking antidepressants caused an additional 14 out of every 1,000 patients under
age 18 to have suicidal thoughts or behavior, he said. About five in every 1,000
patients ages 18 to 24 had an increased risk.
The FDA's action follows an advisory panel's recommendation in December that the
drugs' prescribing information be revised to inform doctors and patients about
suicide risks seen in the trials of young adults during their initial months of
treatment. It's not clear whether there's a long-term risk, the FDA said.
About 16 million Americans take antidepressants each month, according to the
American Psychiatric Association. The group represents psychiatrists and has
argued against stronger warning labels for children and adults.
Some researchers have said the strict ``black-box'' warning about suicide risk
should be eliminated because it discourages the use of antidepressants in young
people, even though these drugs have been shown to alleviate potentially
dangerous symptoms of depression.
Increase in Youth Suicides
The decline in prescribing antidepressants coincided with an increase in youth
suicides reported by the U.S. Centers for Disease Control and Prevention. This
trend ``is a concern'' and will continued to be monitored by the FDA, Laughren
said.
The revised precaution says anyone considering using an antidepressant should
``balance this risk with the clinical need'' for medication.
``We are encouraged that the agency has accompanied the warnings with balanced
information about the importance of being treated for depression,'' said Tammy
Hull, a spokeswoman for Indianapolis-based Lilly, in an e-mailed statement.
``This step will help ensure that the millions of people with depression who are
young adults age 24 and under and their families can make informed treatment
decisions.''
The proposed labeling change will ``preserve antidepressants as a valuable
treatment option,'' said Gwen Fisher, a spokeswoman for Madison, New
Jersey-based Wyeth. The drugmaker found no increased risk of suicide in its
studies of Effexor in adults.
Shreya Prudlo, a spokeswoman for New York-based Pfizer, also said there has been
``no established causal link'' between Zoloft and suicide in any age group.
Forest, based in New York, is reviewing the FDA's request, according to
spokesman Charles Triano.
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