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Study Backs Antidepressant-Suicide Link

by LINDSEY TANNER   The Associated Press July 21, 2004

CHICAGO (AP) - A study of nearly 2,800 British adults and children bolsters the evidence that patients are prone to suicidal impulses when they are first put on antidepressants. But it found no difference in risk between newer and older drugs.

The study looked at four drugs and found that suicidal thoughts or attempts were four times more likely during the first 10 days of treatment than they were after three months. Suicide was almost 40 times more common early on than later in treatment, though there were only 17 suicides, all in patients older than 19.

But the study is unlikely to resolve the debate over whether the drugs themselves increase the suicide risk.

And it may not soothe skeptics who maintain that newer drugs such as Paxil and Prozac that increase brain activity of the mood-regulating chemical serotonin are particularly risky for children. The study found no clear-cut evidence to support that idea, and the researchers did not specifically compare children on antidepressants with those not taking medication.

Some doctors argue that patients just starting on antidepressants are usually in the deepest throes of depression - which itself can cause suicidal behavior - and that the risks subside as the drugs take hold. Others say a medication-induced mood boost may give a profoundly depressed person just enough energy to act on suicidal thoughts.

But some relatives of people who have committed suicide blame the drugs themselves, and British health authorities have said that most serotonin-affecting antidepressants are unsuitable for children. GlaxoSmithKline, the maker of Paxil, has been hit with a lawsuit accusing it of suppressing studies indicating the drug might increase suicidal tendencies in children.

The U.S. Food and Drug Administration is investigating and earlier this year issued a public health advisory asking makers of 10 drugs to add or strengthen suicide-related warnings on their labels. Doctors were warned to watch patients on antidepressants carefully, especially when they first start taking the drugs.

The FDA advisory includes Paxil and Prozac but not the two other drugs studied - amitriptyline and dothiepin, older medications that work differently. The newer drugs have gained favor in part because they have fewer side effects.

The study, by Drs. Herschel and Susan Jick and James Kaye at Boston University, appears in Wednesday's Journal of the American Medical Association. It was funded by the Boston Collaborative Drug Surveillance Program, which received consultation fees from Glaxo in connection with other research. The authors said Glaxo had no role in the current study's design.

The data ``simply means that antidepressants are being prescribed for the right indication, and that they do not immediately eliminate suicide risk,'' Drs. Simon Wessely and Robert Kerwin of London's Institute of Psychiatry said in a JAMA editorial. Still, careful monitoring of youngsters is essential, they said. Wessely has received funding from pharmaceutical companies including Prozac maker Eli Lilly and Co.

The researchers looked at 2,791 first-time users ages 10 to 69 of any of the four drugs from 1993 to 1999.

Suicidal tendencies were 29 percent more common among Paxil users than among dothiepin users studied. Kaye said that finding was statistically insignificant and could reflect doctors' tendency to prescribe the newest drug for more serious cases. Still, he said it ``doesn't exclude the possibility'' that Paxil is more risky.

Dr. David Fassler, a Vermont psychiatrist not involved in the research, said the study leaves key questions unresolved: ``This study isn't specific to children and adolescents, and that's been the area of most recent concern.''

On the Net: JAMA: http://jama.ama-assn.org     

FDA: www.fda.gov/cder/drug/antidepressants/AntidepressantsPHA.htm 

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Study of Antidepressants Finds Little Disparity in Suicide Risk

By BENEDICT CAREY   New York Times    July 21, 2004

Amid an international debate about the side effects of drugs taken for depression, a large-scale analysis of British medical records has found little difference in rates of suicidal behavior among patients given some of the most commonly prescribed medications. The risk is highest when patients begin taking the drugs, as doctors have long suspected, and tapers off quickly after that.

The study, which is being reported today in the Journal of the American Medical Association, found no evidence that withdrawal from the drugs put patients at an increased risk of suicide.

The analysis, conducted and financed by the Boston University School of Medicine, is the largest to compare the suicide risk of the antidepressant drugs Paxil and Prozac with that of older medications like amitriptyline. All the drugs have been commonly prescribed for people with severe depression.

Patients were three to four times more likely to report thoughts of suicide or attempts at it in the first month of treatment than they were after three months on the drugs, the analysis found. The findings were similar for each medication, whether prescribed for adults or children.

Experts said the study should reassure psychiatrists and other doctors concerned about hidden differences between the risks of the newer antidepressants, like Prozac, and the older varieties. The experts also said that it confirmed the importance of watching patients closely when they begin treatment.

"It's starting treatment itself, more than what drug you start with, that's the important factor," said Dr. James A. Kaye, an author of the study along with Dr. Hershel Jick and Dr. Susan S. Jick. Most psychiatrists believe that the drugs reduce the overall risk of suicide.

The analysis does not help answer the central question underlying the safety debate: Do some people become more suicidal on the drugs? Compared with those on placebos, depressed children in particular have reported an increase in suicidal thoughts when taking antidepressants during some clinical trials.

"This study does not speak at all to taking the drugs versus not taking them," said Dr. Jeffrey A. Lieberman, a professor of psychiatry and pharmacology at the University of North Carolina.

Concerns that the drugs might increase the suicide risk for some children prompted the Food and Drug Administration to caution doctors earlier this year that young patients should be monitored carefully, especially during the first weeks of treatment. Late last year, British health officials banned the use of all drugs but Prozac for treating depression in patients younger than 18.

The Boston University doctors analyzed the computerized medical records of 159,810 patients treated for depression between 1993 and 1999 in Britain, which keeps a detailed database of health information on millions of its citizens. The patients ranged from 10 to 69 years old and could have taken only one brand of antidepressant: Prozac, from Eli Lilly; Paxil from GlaxoSmithKline; amitriptyline; or dothiepin, which is not available in the United States.

Among these patients, the researchers found 555 had showed signs of suicidal thinking or behavior for the first time in the months after they started on antidepressants.

Regardless of age or sex, they were four times more likely to begin acting suicidal in the first 10 days of treatment than they were after 90 days. And they were three times more likely to show such signs during the rest of the first month of treatment than later on.

It did not matter much which drug they took. The risk of suicidal behavior for those who started on Paxil was slightly higher than for those on the other drugs, but the difference was so small that it could have been due to chance or to something the researchers did not take into account, they said. For instance, Dr. Kaye said, Paxil, the newest of the drugs, may have been prescribed for suicidal cases more often than the others.

Researchers do not know why the risk of suicidal behavior was highest during the first weeks of treatment. The most likely explanation, they said, is that patients are at a low point when depression is diagnosed and they start on a drug.

 

This 'Mental Health E-News' posting is a service of the New York Ass'n of Psychiatric Rehabilitation Services, a statewide coalition of people who use and/or provide community mental health services dedicated to improving services and social conditions for people with psychiatric disabilities by promoting their recovery, rehabilitation and rights. To join our list, please click on the E-News Subscription button.

Last Updated on 07/26/04   webmaster@namiscc.org

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