Regulator to examine drug's links with suicide

Anti-depressants: The Irish Medicines Board is evaluating the findings of a new study which found that commonly used anti-depressants…

Anti-depressants: The Irish Medicines Board is evaluating the findings of a new study which found that commonly used anti-depressants can cause adults, as well as children, to attempt suicide.

Experts have already warned against the use of such drugs, known as SSRIs (selective serotonin re-uptake inhibitors), for children and adolescents due to an increased risk of suicidal thoughts.

However, the latest study, published yesterday in the BMC Medicine journal, suggests these warnings should also be extended to adults.

It said GlaxoSmithKline, which makes the commonly-used drug Seroxat, did not submit its original data from clinical trials of the drug to the medicines regulator in Britain.

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The lack of a detailed breakdown between suicide attempts and suicidal thinking distorted the conclusions of the dangers of the drug, according to the study's authors.

Using information from original trials, researchers found that in 16 trials there were seven attempted suicides among people taking Seroxat, compared to one among those given a placebo.

Official figures in the Republic suggest around 300,000 patients, are prescribed various kinds of anti-depressants each year. Seroxat is one of the most commonly-prescribed of these drugs.

However, GlaxoSmithKline said yesterday it disagreed with the findings which, it said, were based on information that was collected 15 years ago.

The research failed to take account of later research by EU authorities which reaffirmed the positive benefit-risk for Seroxat - or paroxetine as it is also known - use in the treatment of depression and anxiety disorders in adults.

"The [ recent study's findings] serves only to cause confusion and unnecessary concern for patients using an SSRI, such as paroxetine, for treatment of depression," the firm said in a statement.

The Irish Medicines Board (IMB) said yesterday it actively monitored and evaluated new information and data for all medicinal products available on the Irish market on a continuous basis.

While the latest findings will be examined by the IMB, it said its most recent review of paroxetine-containing medicines concluded that the "risk benefit profile" of these products for the treatment in adults remained positive.

Further reviews are ongoing.

In a statement, it said: "The IMB will continue to closely monitor all safety issues relating to anti-depressants and to collaborate with colleagues from other EU member states in the evaluation of these issues. Any further regulatory action deemed necessary will be taken by the IMB."

While many people say it has changed their lives by lifting them out of depression, some have experienced painful side-effects when they tried to reduce the dose or stop taking it.

In Britain, at least 1,000 men and women who claim to be addicted to the anti-depressant are seeking legal action against the manufacturers.

A number of Dublin-based legal firms are to seek compensation for alleged adverse symptoms suffered by clients after they stopped using Seroxat.

Carl O'Brien

Carl O'Brien

Carl O'Brien is Education Editor of The Irish Times. He was previously chief reporter and social affairs correspondent