New baby alert over Seroxat
By Celia Hall, Medical Editor
Last Updated: 12:49am BST 29/09/2005
A new caution over the anti-depressant, Seroxat, has been issued, advising doctors that it could increase the risk of abnormalities in babies if given to women in the first three months of pregnancy.
In America the product leaflet has already been changed to give the new information and a letter to doctors from the manufacturers, GlaxoSmithKline, has been published on the website of the regulatory authority, the Food and Drug Administration (FDA). In Britain and Europe the regulators are still considering the new data, provided by Glaxo at the end of last month.
Seroxat is one of the most widely prescribed anti-depressants, taken by an estimated 2.4 million people in the UK. The drug is only prescribed to pregnant women who are severely depressed when a doctor decides that the benefit to the women outweighs any risk to the foetus.
Last year the Medicines and Healthcare Products Regulatory Agency said that Seroxat should not be given to children under 18 and doctors have been warned that the drug and others in the same class have been prescribed too freely.
The new data, from a Glaxo study, suggests that the risk of congenital abnormalities and heart abnormalities may be raised among women taking Seroxat compared with other anti-depressants.
“GSK is conducting additional epidemiologic studies to more fully understand these preliminary findings,” the company said.
An earlier independent study of 4,291 infants, from Sweden, found no increased risk of birth defects for women who took Seroxat early in pregnancy.
A spokesman said: “The current product information states that Seroxat (paroxetine) should be used during pregnancy only when strictly indicated. 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.”
The new data indicated a four per cent risk of congenital abnormality when the drug was taken compared with a population risk of three per cent and a two per cent risk of heart abnormality compared with a one per cent risk.
A spokesman for the MHRA said: “Previous epidemiological data have not provided evidence of an increased risk of birth defects with SSRI antidepressants such as paroxetine. The MHRA is carefully considering all available data and will seek expert advice from the Committee on Safety of Medicines and issue advice as necessary.”