Doctors told not to prescribe Seroxat

The Telegraph
Dec. 11, 2005

Doctors have been warned not to give pregnant women a leading anti-depressant drug because it may cause birth defects.

The move follows evidence from Sweden that suggested women who took paroxetine - sold in Britain as Seroxat - during early pregnancy, were twice as likely to give birth to a child with a heart defect.

A separate study revealed that use of paroxetine, rather than other antidepressants, increased the risk of birth defects, such as cleft palate, by a third.

The Medicines and Healthcare products Regulatory Agency (MHRA) has written to all doctors and midwives in Britain alerting them to the potential dangers and told them to avoid prescribing paroxetine to pregnant women.

In the letter, Professor Gordon Duff, the chairman of the MHRA's Commission on Human Medicines, said: "Paroxetine should only be used in pregnancy when strictly indicated and only if the benefits for the mother are thought to outweigh the potential risk to the foetus.

"Until this issue is further investigated, consideration should be given as to whether paroxetine is the most suitable SSRI [selective serotonin re-uptake inhibitor] to be used in pregnant women or those planning to become pregnant."

In America, the Food and Drug Administration has issued a similar warning and ordered GlaxoSmithKline, the manufacturer, to change the product's labelling to that of a "Category D" drug - indicating that clinical studies in pregnant women have demonstrated a risk to the foetus.

The FDA noted that studies had only looked at the effects of paroxetine in the first three months of pregnancy and that a risk of birth defects as a result of the drug's use in later pregnancy could not be ruled out.

The development is the latest in a series of blows to paroxetine. Last year the MHRA said that it should not be given to children under 18 because it could raise their risk suicide. Last year the Sunday Telegraph reported that pregnant women who use paroxetine and similar drugs could be damaging the brains of their unborn babies.

Last night's warning from the MHRA is, however, the first official recognition of the danger these drugs may pose to unborn children.

An estimated 25,000 of the 600,000 babies born in England and Wales each year are believed to have been exposed in the womb to SSRIs, which includes brands such as Prozac and Seroxat. Paroxetine is now the biggest selling SSRI in the world - although no exact figures are available for the number of women taking paroxetine while in the first stages of pregnancy.

A spokesman for GlaxoSmithKline said: "Doctors are advised to carefully weigh the potential risks and benefits of using paroxetine therapy in women during pregnancy. Patients who are concerned shouldn't stop taking their medication without consulting their doctor.

"GlaxoSmithKline recently received this new data, and is reviewing these findings with regulators to consider the labelling implications."