article from the Kitchener-Waterloo Record, Oct 12/05

Paxil linked to birth risks

(Oct 12, 2005)

Health Canada has issued a warning about the use of Paxil during pregnancy, based on evidence that suggests the risk of major birth defects is doubled in babies born to women who took the antidepressant during the first trimester of pregnancy.

A large U.S. study conducted by the drug's maker, GlaxoSmithKline, found the rate of major birth defects, particularly heart-related defects, was twice as high in babies born to women who used paroxetine -- the drug's generic name -- in the first trimester.

Health Canada said in a release the majority of the heart-related defects were ventricular septal defects, which are holes in the muscular wall that separates the left and right lower chambers of the heart. These types of defects are usually considered mild and the majority -- 80 to 90 per cent -- spontaneously reverse after birth.

"We've requested the manufacturer to submit a request to change the prescribing information,'' said department spokesperson Jirina Vlk.

The study, based on U.S. health insurance data, found the prevalence of major congenital defects and cardiovascular defects to be four per cent and two per cent respectively in women who had taken Paxil, versus three per cent and one per cent in the overall population.

Health Canada urged doctors to use caution when considering the use of paroxetine during pregnancy and to include the new safety information in the discussion with the patient about risks and benefits.

It also urged women who are taking Paxil and who are pregnant or are planning to become pregnant to talk about the risks with their doctors. It warned patients not to stop taking medication without consulting their physicians.