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From: Subject: DenverPost.com - NATION/WORLD Date: Sun, 17 Oct 2004 05:45:58 +0200 MIME-Version: 1.0 Content-Type: multipart/related; boundary="----=_NextPart_000_0000_01C4B40C.93B16420"; type="text/html" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2800.1441 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C4B40C.93B16420 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.denverpost.com/Stories/0,1413,36~11676~2471428,00.html DenverPost.com - NATION/WORLD

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EMAIL=20 ARTICLE LINK=20 TO ARTICLE PRINT=20 ARTICLE

Article Published: = Saturday, October=20 16, 2004

Drugs'=20 suicidal effects prompt warning

The FDA=20 orders labels on antidepressants to note an increased risk = of=20 suicidal behaviors in minors.

By = Anne C.=20 Mulkern
Denver Post Staff Writer

Getty = Images

Paxil=20 tablets.

Washington - All antidepressants must now carry a=20 prominent alert warning doctors that the drugs increase the = risk of=20 suicidal thoughts and behaviors in patients under 18 years = old,=20 federal drug regulators said Friday.=20

Reacting to vociferous public concern and a new study = that=20 validates the higher risk in children and teens, the U.S. = Food and=20 Drug Administration decided to use one of its strongest = enforcement=20 tools, the "black- box" label. The warning sits at the top = of the=20 drug's prescribing information, surrounded by a black = box.

Information in the label must be included in any = advertisements=20 for the drug. The text would have to be read in any = television or=20 radio advertisement. That is expected to reduce, if not = eliminate,=20 what has been prolific advertising for the drugs. Free = samples given=20 by doctors also must carry the warning.

Advertisement

About 10 million to 11 million prescriptions for newer=20 antidepressants were written for children and teenagers in = 2003.

"These drugs should not be used casually," said Dr. = Sandra=20 Kweder, the FDA's acting director in the Office of New = Drugs.

Doctors can still prescribe the drugs, but with the = black-box=20 warning, they need to carefully balance "the risk with the = need,"=20 Kweder said. That new label should appear within a month or = two.

An FDA study released last month showed that for every = 100=20 children and teenage patients taking newer-generation=20 antidepressants, two to three had suicidal thoughts or=20 behaviors.

Compounding that finding, the FDA has conceded that = clinical=20 trials failed to show the drugs work in children and = teenagers, with=20 the exception of Prozac.

"We continue to believe, however, that these drugs = provide=20 significant benefits for pediatric patients when used=20 appropriately," said Dr. Lester Crawford, acting FDA=20 commissioner.

Rep. Diana DeGette, D-Denver, who sits on a committee=20 investigating the FDA's inaction on the issue, called the = decision=20 "the kind of action that the FDA should have taken a long = time=20 ago."

"Black-box" advisories to appear on labels=20

The U.S. Food and Drug Administration is ordering = drugmakers to=20 post "black-box" warnings - its most serious warning - on = all=20 antidepressants.

The new warnings will be carried on: Anafranil, Aventyl, = Celexa,=20 Cymbalta, Desyrel, Effexor, Elavil, Lexapro, Ludiomil, = Luvox,=20 Marplan, Nardil, Norpramin, Pamelor, Parnate, Paxil, Pexeva, = Prozac,=20 Remeron, Sarafem, Serzone, Sinequan, Surmontil, Symbyax, = Tofranil,=20 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=20 behavior (suicidality) in children and adolescents with = major=20 depressive disorder (MDD) and other psychiatric disorders. = Anyone=20 considering the use of (DRUG NAME) or any other = antidepressant in a=20 child or adolescent must balance this risk with the clinical = need."

The text of the letter sent to drug manufacturers and the = full=20 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=20 so that the agency will not allow future drugs to get to the = market=20 before their safety has been thoroughly examined," DeGette = said.

The new labels must also state whether the drugs have = been=20 approved for use in children and for which disease. Some are = approved for obsessive-compulsive disorder. Only Prozac has = FDA=20 approval for treatment of major depressive disorder.

A recent study found as many as 89 percent of = antidepressant=20 prescriptions for children are "off-label," or written by = doctors=20 for unapproved uses, said Dr. Joseph Glenmullen, a Harvard=20 psychiatrist.

"The FDA is still not doing enough to protect American = children=20 from this potentially lethal side effect," Glenmullen = said.

However, psychiatrist David Fassler, with the American=20 Psychiatric Association, said he feared "the new warnings = may=20 confuse and frighten some parents and make them less likely = to seek=20 help for their children."

Drug manufacturers said they are willing to work with the = FDA and=20 are concerned about untreated depression.

"Depression is responsible for more than 500,000 suicide = attempts=20 by children and adolescents annually," said Shreya Prudlo,=20 spokeswoman for Pfizer, maker of Zoloft. "Today, suicide is = the=20 third leading cause of death among adolescents, making it = one of the=20 most urgent public health issues facing the United = States."

Staff writer Anne C. Mulkern can be reached at = 202-662-8907 or=20 amulkern@denverpost.com=20 .

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All contents Copyright 2004 The Denver = Post or=20 other copyright holders. All rights reserved. This material may = not be=20 published, broadcast, rewritten or redistributed for any = commercial=20 purpose.

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