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Healthy Skepticism Library item: 4730

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Silverman E.
Drug maker warns of link between Paxil and suicide
Star-Ledger 2006 May 13
http://www.nj.com/news/ledger/index.ssf?/base/news-6/114749682244320.xml&coll=1

Keywords:
Paxil suicide antidepressant


Notes:

Ralph Faggotter’s Comments:

“ The American Psychiatric Association last year began a campaign to promote continued use of the pills…”

The American Psychiatric Association runs the risk of being seen as indifferent to the risk of anti-depressant induced suicide if it continues with its current stance.


Full text:

Drug maker warns of link between Paxil and suicide
Saturday, May 13, 2006
BY ED SILVERMAN
Star-Ledger Staff

An analysis of clinical studies found Paxil, an antidepressant drug, increases the risk of suicidal behavior in young adults, marking the first time a drugmaker has acknowledged such a relationship.

The results of the analysis were disclosed yesterday by GlaxoSmithKline, which sent a letter to doctors and changed the product labeling on its widely used pill. The London-based drugmaker analyzed data involving nearly 15,000 patients who participated in earlier studies of the medication.

The data showed 11 Paxil patients reported suicide attempts compared with only one who was given a placebo, or dummy pill, which the company called statistically significant. Of the 11 patients, eight were younger than 30. No actual suicides were recorded.

In discussing the findings, Glaxo said there was no causal relationship between Paxil and suicidal behavior. But the company acknowledged the higher rate may extend beyond young adults and cautioned doctors to consider discontinuing the medication if patients display suicidal symptoms.

The move comes 18 months after the Food and Drug Administration required all drugmakers selling antidepressants to place strong warnings on product label ing about increased suicide risks for youngsters and adults. That step came after it became known that negative clinical-trial data for some antidepressants had never been revealed.

Since then, the debate about antidepressants has intensified. The American Psychiatric Association last year began a campaign to promote continued use of the pills out of concern some patients may be scared by the headlines or unnecessarily deprived of a useful treatment.

One patient advocate said the findings confirm long-standing anxiety about antidepressants.

“What they now admit is the same thing they denied all these years,” said Vera Sharav of the Alliance for Human Research Protection, who is a critic of the pharmaceutical industry. “There’s really no evidence to exclude any age group from the risk posed by this or any of the drugs.”

Charles Kellner, who chairs the psychiatry department at the University of Medicine & Dentistry of New Jersey, said the findings should act as a “wake-up call” for doctors to be careful when treating patients with psychiatric problems.

“I don’t think it’s a phenomenon related just to this specific drug,” said Kellner. “It’s a class phenomenon. Treatment of de pression needs to be very careful. Hopefully, this will lead to better and closer patient follow-up.”

Ed Silverman may be reached at (973) 392-1542 or esilverman@starled ger.com

 

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...to influence multinational corporations effectively, the efforts of governments will have to be complemented by others, notably the many voluntary organisations that have shown they can effectively represent society’s public-health interests…
A small group known as Healthy Skepticism; formerly the Medical Lobby for Appropriate Marketing) has consistently and insistently drawn the attention of producers to promotional malpractice, calling for (and often securing) correction. These organisations [Healthy Skepticism, Médecins Sans Frontières and Health Action International] are small, but they are capable; they bear malice towards no one, and they are inscrutably honest. If industry is indeed persuaded to face up to its social responsibilities in the coming years it may well be because of these associations and others like them.
- Dukes MN. Accountability of the pharmaceutical industry. Lancet. 2002 Nov 23; 360(9346)1682-4.