IMB advises against 'Seroxat' in pregnancy

THE IRISH Medicines Board (IMB) has advised women who want to become pregnant and are taking the antidepressant Seroxat to discuss the risks and benefits of continued treatment beforehand with their doctor.

It has also advised that pregnant women who are taking the antidepressant should not stop their treatment without seeking advice from their doctors.

Some studies have found an increased risk of birth defects, particularly heart defects, associated with the use of Seroxat during the first three months of pregnancy. These findings are not new, but last week Irish psychiatrist Prof David Healy, who is based in Wales, said he believed many GPs still prescribed Seroxat to women without adequately informing them of the risks.

He pointed to studies showing that the rate of birth defects and miscarriage doubled if a woman was taking Seroxat.

“Ten to 15 years ago, most doctors would have been quite cautious about the idea of putting any woman who was pregnant or thinking about becoming pregnant on one of these drugs but the culture has changed,” he said.

The IMB said it had highlighted the link between birth defects and Seroxat to healthcare professionals in a newsletter three years ago.

It also approved a letter from Seroxat manufacturer GlaxoSmithKline, which was sent to all healthcare professionals in the same year. That letter highlighted that paroxetine (Seroxat) should be used in pregnancy only when strictly indicated and said doctors should prescribe Seroxat to pregnant women only if the potential benefits outweigh the potential risks.

Thousands of Irish women are prescribed antidepressants but it is not known how many pregnant women are taking Seroxat.

Dr Mark Walsh, chairman of the Irish College of General Practitioners (ICGP), said he did not believe the prescribing of Seroxat to pregnant women was widespread in Ireland. “The ideal thing is not to prescribe anything at all during pregnancy,” he said.

However, people did become depressed and GPs had to make a clinical decision based on each individual case. The potential risks of any medication should always be discussed with the patient, he said. He said Seroxat was a good drug in certain cases but other antidepressants had a lower risk factor if a pregnancy was involved and GPs were aware of the potential risks.

The prescribing of the antidepressant to women who might become pregnant could also be problematic as some women find themselves unable to stop taking the drug when they become pregnant.

A number of legal actions will soon begin in the US over the antidepressant. Lawyers representing women suing GlaxoSmithKline claim the manufacturer knew, or should have known, about the birth defects more than 10 years ago because of research findings.

GlaxoSmithKline said it had been monitoring reports of foetal exposure to paroxetine since the first studies of the drug and it was not until the summer of 2005 that it became aware of a potential increased risk. It said it notified the regulatory authorities and healthcare professionals and included the information in the product leaflet accompanying the antidepressant.

In 2005, the Food and Drug Administration in the US advised doctors not to prescribe Seroxat to women in the first three months of pregnancy or who were planning pregnancy, unless other treatment options were not appropriate.