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Article Published: Saturday, October
16, 2004

Drugs'
suicidal effects prompt warning

The FDA
orders labels on antidepressants to note an increased risk of
suicidal behaviors in minors.

By Anne C.
Mulkern
Denver Post Staff Writer

Getty Images

Paxil
tablets.

Washington - All antidepressants must now carry a
prominent alert warning doctors that the drugs increase the risk of
suicidal thoughts and behaviors in patients under 18 years old,
federal drug regulators said Friday.

Reacting to vociferous public concern and a new study that
validates the higher risk in children and teens, the U.S. Food and
Drug Administration decided to use one of its strongest enforcement
tools, the "black- box" label. The warning sits at the top of the
drug's prescribing information, surrounded by a black box.

Information in the label must be included in any advertisements
for the drug. The text would have to be read in any television or
radio advertisement. That is expected to reduce, if not eliminate,
what has been prolific advertising for the drugs. Free samples given
by doctors also must carry the warning.

Advertisement

About 10 million to 11 million prescriptions for newer
antidepressants were written for children and teenagers in 2003.

"These drugs should not be used casually," said Dr. Sandra
Kweder, the FDA's acting director in the Office of New Drugs.

Doctors can still prescribe the drugs, but with the black-box
warning, they need to carefully balance "the risk with the need,"
Kweder said. That new label should appear within a month or two.

An FDA study released last month showed that for every 100
children and teenage patients taking newer-generation
antidepressants, two to three had suicidal thoughts or
behaviors.

Compounding that finding, the FDA has conceded that clinical
trials failed to show the drugs work in children and teenagers, with
the exception of Prozac.

"We continue to believe, however, that these drugs provide
significant benefits for pediatric patients when used
appropriately," said Dr. Lester Crawford, acting FDA
commissioner.

Rep. Diana DeGette, D-Denver, who sits on a committee
investigating the FDA's inaction on the issue, called the decision
"the kind of action that the FDA should have taken a long time
ago."

"Black-box" advisories to appear on labels

The U.S. Food and Drug Administration is ordering drugmakers to
post "black-box" warnings - its most serious warning - on all
antidepressants.

The new warnings will be carried on: Anafranil, Aventyl, Celexa,
Cymbalta, Desyrel, Effexor, Elavil, Lexapro, Ludiomil, Luvox,
Marplan, Nardil, Norpramin, Pamelor, Parnate, Paxil, Pexeva, Prozac,
Remeron, Sarafem, Serzone, Sinequan, Surmontil, Symbyax, Tofranil,
Tofranil-PM, Triavil, Vivactil, Wellbutrin, Zoloft and Zyban.

The warning labels will read, in part:

Suicidality in Children and Adolescents

"Antidepressants increase the risk of suicidal thinking and
behavior (suicidality) in children and adolescents with major
depressive disorder (MDD) and other psychiatric disorders. Anyone
considering the use of (DRUG NAME) or any other antidepressant in a
child or adolescent must balance this risk with the clinical
need."

The text of the letter sent to drug manufacturers and the full
text of the proposed black-box wording can be found at:

www.fda.gov/cder/drug/antidepressants/SSRIlabelChange.htm
"I
hope that this will spur the FDA to re-examine their review process
so that the agency will not allow future drugs to get to the market
before their safety has been thoroughly examined," DeGette said.

The new labels must also state whether the drugs have been
approved for use in children and for which disease. Some are
approved for obsessive-compulsive disorder. Only Prozac has FDA
approval for treatment of major depressive disorder.

A recent study found as many as 89 percent of antidepressant
prescriptions for children are "off-label," or written by doctors
for unapproved uses, said Dr. Joseph Glenmullen, a Harvard
psychiatrist.

"The FDA is still not doing enough to protect American children
from this potentially lethal side effect," Glenmullen said.

However, psychiatrist David Fassler, with the American
Psychiatric Association, said he feared "the new warnings may
confuse and frighten some parents and make them less likely to seek
help for their children."

Drug manufacturers said they are willing to work with the FDA and
are concerned about untreated depression.

"Depression is responsible for more than 500,000 suicide attempts
by children and adolescents annually," said Shreya Prudlo,
spokeswoman for Pfizer, maker of Zoloft. "Today, suicide is the
third leading cause of death among adolescents, making it one of the
most urgent public health issues facing the United States."

Staff writer Anne C. Mulkern can be reached at 202-662-8907 or
[email-masked]
.

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