• Drugs in pregnancy

    Drugs in pregnancy

    Pregnant women with epilepsy are a highly vulnerable population; they have to balance the risk posed to the pregnancy from having a fit, against the risk of taking medicines to control the fits.

    There are a few anti-epileptic drugs which have been shown to increase the risk of congenital malformations in the baby; the risk is reduced considerably by the use of Folic Acid, which is now used even in pregnant women without epilepsy.

    One great difficulty in this situation is of getting information on safety of any new drug in pregnancy; while safety is not established, it is considered unsafe to expose the mother and the baby to any drug. That is why, whenever a new drug is introduced into the market, there is a disclaimer that its safety in pregnancy is unknown.

    The general guideline is to avoid using any new drug during pregnancy. Hence, data on safety in pregnancy is obtained only by anecdotal reports where someone has been accidentally exposed to the drug – and for this a Pregnancy Register is established in most countries.

    An extremely well – designed study was recently published on this topic, and some very useful information was obtained about safety of anti – epileptic drugs in pregnancy. Read on for more information.

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    THE STUDY

    Recently the results of a very large study were published in the journal JAMA Neurology. This was a study conducted on pregnant women who are on anti-epileptic drugs – to identify what effects they had on the motor skills of the babies born.

    This study was conducted in Norway, and included women in the 13th – 17th week of pregnancy who were on one or more anti – epileptic drug, in the period 1999 – 2009.

    This is an extremely good study because a large number of participants were included, and the study was PROSPECTIVE in design – which means that participants entered the trial at the beginning and were then followed for a pre – decided length of time (as opposed to a RETROSPECTIVE study, in which analysis is done after the study period is over. In a Retrospective study, considerable observer bias is expected).

    Since the period also was long – a full decade, this classifies as a LONGITUDINAL study – which is again one of the best designs for a study.

    The mothers were on one or more than one anti – epileptic drugs, and the infants were examined at 6 months (n = 78 744), 18 months (n = 61 351), and 36 months (n = 44 147) after birth. They were examined for motor and social skills, language, and behavior using items from standardized screening tools.

    The mothers also provided detailed information on breastfeeding during the first year.

    FINDINGS:

    The study authors found that the risk of impaired fine motor skill at 6 months in infants of mothers on anti – epileptic drugs was 11.5 % compared to 4.8 % in the reference group, who were not on anti – epileptic drugs.

    At 18 months, the risk was 25% vs 4.8%; at 36 months, the risk was 22.5% vs 10.2%.

    Breast – feeding did not impose any additional risk; which means that a mother who is on anti – epileptic drug can safely breast – feed her baby without worrying about impaired fine motor skills.

     

    CONCLUSIONS:

    The authors conclude that the use of anti – epileptic drugs is associated with impaired fine motor skills in infants seen as early as 6 months after birth, and this is especially more if the mother is on more than one anti – epileptic drugs. They also found that breast – feeding while on anti – epileptic drug does not impose any additional risk, and recommend that all mothers on anti – epileptic drugs should be encouraged to breast – feed their babies.

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