Safety of paroxetine in pregnancy addressed
During pregnancy, paroxetine should only be used when strictly indicated |
Following concerns raised recently in the scientific and lay media over the safety of paroxetine in pregnancy, the Commission on Human Medicines has written to health care professionals with advice.
The letter states that new data from Denmark, Sweden and the US indicate
a potential increased risk of congenital malformations following use
of paroxetine in the first trimester. The studies suggest that the risk
of birth defects may increase from 3 per cent to 4 per cent for all congenital
malformations and from 1 per cent to 2 per cent for congenital heart
malformations. “Therefore, if real, any increased risk is small
and needs to be considered in the context of the potentially greater
risk to the fetus from the mother’s depression remaining untreated,” says
the CHM. It also stresses that other epidemiological studies have not
supported this increased risk. The risk of withdrawal signs in neonates
of mothers who continue to use paroxetine into the later stages of pregnancy
are also highlighted.
Prescribers are told that paroxetine should only be used in pregnancy
when strictly indicated and when the benefits outweigh the risks. Consideration
should be given as to whether paroxetine is the most appropriate selective
serotonin reuptake inhibitor to be used in pregnant women and those who
are planning to become pregnant, the CHM suggests. It reminds prescribers
that if paroxetine is withdrawn, it should be done so gradually over
several weeks. |
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