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FDA urges new adult warnings
on antidepressants
Lisa Richwine
Reuters
Wednesday May 02, 2007
Warnings on antidepressant drugs should be expanded to say the
risks of suicidal thoughts and behavior extend to adults ages 18
to 24, U.S. health officials said on Wednesday.
The danger decreases, however, for adults 65 and older when they
take the medicines, the Food and Drug Administration said. New warning
labels should note that finding and stress that depression and some
other psychiatric disorders are themselves a major causes of suicide,
officials said.
The drugs already come with strong warnings that taking them may
increase the chances of suicidal thoughts or actions in children
and teenagers. Many psychiatrists have criticized the warnings,
saying they scare people away from effective treatment and may have
contributed to an increase in suicide in recent years.
Millions of Americans take antidepressants. The drugs include Wyeth's
Effexor, Pfizer Inc.'s Zoloft, GlaxoSmithKline Plc's Paxil, Eli
Lilly and Co's Prozac and Cymbalta, and Forest Laboratories Inc.'s
Lexapro.
The FDA reviewed 295 studies of various antidepressants that included
more than 77,000 adults.
The analysis found a "slight increase" in suicidal thinking
and behavior among young adults during early treatment, which was
generally the first one to two months, the FDA said. The data did
not find a higher risk for adults older than 24.
For every 1,000 patients treated, about five more cases of suicidal
thoughts and actions were reported among 18- to 24-year-olds who
took the drugs rather than a placebo.
"The risk is quite small, but we think it is a real risk and
it's something that needs to be paid attention to," Dr. Thomas
Laughren, director of the FDA's division of psychiatry products,
told reporters.
Fourteen additional cases were seen in patients under 18 who took
antidepressants. For people 65 and older, there were six fewer cases.
Patients of any age who start taking antidepressants should be
monitored for worsening depression, suicidal actions or unusual
changes in behavior, FDA officials said. Anyone now taking one of
the drugs should not stop, but should consult a doctor if they have
concerns, they said.
Some psychiatrists have urged the FDA to remove or revise the warnings
for children, which are highlighted in a "black box,"
the most serious type of warning for prescription drugs.
Prescriptions dropped after the warning for children and teens
was added in 2004. The cautions about adults would be added to that
warning.
The American Psychiatric Association said it was pleased the FDA
now wanted the black box to note that depression itself may lead
to suicide.
Dr. Carolyn Robinowitz, the group's president-elect, said the revised
warning was "a major step in the right direction."
"We believe the new label, which still contains important
warning information, reminds physicians and patients that antidepressants
save lives," she said.
Researchers who published a study in April in the Journal of the
American Medical Association said they found the benefits of antidepressants
for children and teens far outweighed the risk of suicidal thoughts
and behavior.
Pfizer will add the new warning for young adults to the Zoloft
label, company spokeswoman Shreya Prudlo said. She added "there
is no established causal link between Zoloft and suicide in adults,
young adults or children."
Officials at Lilly, Forest and Wyeth also said the companies would
add the new warnings to their products.
INFOWARS:
BECAUSE THERE'S A WAR ON FOR YOUR MIND
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