Heya crazies,

I just got this Dear Healthcare Professional Letter:

(this is just a summary since I can't figure how to scan it in)

(Also I didn't know where to post this so move it if somewhere else makes more sense)

GSK and Health Canada would like to inform you of important new safety information concerning the antiepileptic, LAMICTAL ® (lamotrigine).

Emerging datea from the North American Antiepileptic Drug (NAAED) Pregnancy Registry suggest an association between lamotrigine and an increased risk of non-syndromic oral clefts over the reference population for the registry (ie. Active Malformations Surveillance Program at Brigham and Women's Hospital in Boston, USA).

Recently published data from the Registry report three cases of isolated, non-syndromic cleft palate and two cases of isolated, no-syndromic cleft lip without cleft palate in infants from 564 first-trimester lamotrigine monotherapy exposures, giving a rate of 8.9 per 1000, as compared to 0.37 per 1000 in the reference population for that registry.

The prevalence of oral clefts noted in the NAAED registry is also higher than the backgrround prevalence of non-syndromic oral clefts reported in the literature, including studies from the United States, Australia and Europe. While different studies have differing results due to geographic and case ascertainment variations, the reported range is 0.50 to 2.16 per 1000.

To assist with the assessment of risk, analysis of data from additional pregnancy registries, with approximately 2200 additional lamotrigine monotherapy first-trimester exposures has been conducted, and 4 additional non-syndromic cases of oral cleft have been identified. Follow-up information will be provided via the appropriate channels when available.

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Non-syndromic oral cleft refers to a kid having cleft lip +- cleft palate, with no other malformations.

Five cases in 564 pregnancies doesn't sound like much, and extrapolating this to the population is tricky. But it looks real on the face of it.

Something to add in to our already complicated risk-benefit anlysis anytime one of us thinks about pregnancy, MI, and drugs.

BTW.

Lamotrigine Pregnancy Registry: 1-800-336-2176
NAAED Pregnancy Registry: 1-888-233-2334
(that one's for all the antiepileptic drugs)