UK Women Still in the Dark About SSRI Birth Defect Risk

Bangor, WalesIt will be two years next month that a study of nearly 500,000 women by researchers at the University of Pittsburgh Medical Center revealed nearly half of women taking an ssri antidepressant had no idea their medication could cause SSRI birth defects.

Women in the US aren't unique in that risk. Dr. Tim Kendall, joint director of the UK-based National Collaborating Center for Mental Health, maintains that GPs in Britain are still prescribing SSRI antidepressants to pregnant women and those of childbearing age without warning of the dangers.

Those dangers were articulated by the US Food and Drug Administration (FDA) in 2005.
One of those drugs, Paxil—which is sold in the United Kingdom as Seroxat—was singled out by the FDA, which warned doctors "not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate."

Reacting in kind the Medicines and Healthcare products Regulatory Authority in the UK urged doctors to prescribe Seroxat / Paxil for pregnant women only when the benefits outweighed the risks.

It's not just Seroxat / Paxil at fault. All drugs linked to SSRI birth defects can be implicated, according to David Healy, a professor of psychiatry in Bangor, Wales. Professor Healy said the rate of birth defects in the UK doubled from 2 percent in the general population to 4 percent inherent with SSRI exposure. Rate of major birth defects rises from 1 percent to 2 percent. As for miscarriages the general rate is 8 percent, compared with 16 percent for women taking Seroxat / Paxil.

It was noted in the Guardian that Pfizer, the manufacturer of Zoloft, indicated in the British National Formulary that Zoloft was not recommended for women who might become pregnant. The warning, said Healy "probably did very little to deter women from taking the drug or doctors from prescribing it, but (GlaxoSmithKline) went further and actually promoted the drug to women of childbearing age."

GlaxoSmithKline (Glaxo) is the manufacturer of Seroxat / Paxil. In its defense, Glaxo had this to say:

"Tragically, birth defects can occur whether or not the mother was taking medication during pregnancy. We have monitored reports of foetal exposure to paroxetine since the first studies of the drug and there was no indication of increased risk from studies, adverse event reports or any other source until the summer of 2005.
"As soon as we became aware of a potential increased risk, we promptly notified regulatory authorities and physicians. We strongly believe that doctors should be advised of the potential risk of medicines before prescribing them, and the potential risk of paroxetine use during pregnancy is detailed in the information provided with the medicine." (guardian.co.uk August 7, 2009)
As various SSRI birth defect lawsuits are set to begin, the debate over ssri antidepressants rages on.