December 2017

Is it safe to use lamotrigine during pregnancy? A prospective comparative observational study

Birth Def Res 109: 1196-1203 (2017)

Evaluation study of the rate of major anomalies after lamotrigine exposure during pregnancy compared with pregnancies of women counseled for nonteratogenic exposure using prospective follow-up of callers to the Israeli Teratology Information Service between 1997 and 2008. The rate of major congenital anomalies was similar between 218 lamotrigine exposed pregnancies (208 in the first trimester) and 865 NTE-pregnancies with no cases of oral cleft in the lamotrigine-exposed group.

Major Birth Defects after Vaccination Reported to the Vaccine Adverse Event Reporting System (VAERS), 1990 to 2014.

Birth Defects Res. 109:1057-1062 (2017)

Report of a postmarketing surveillance of the presence of major birth defects following vaccination to the spontaneous reporting Vaccine Adverse Event Reporting System from 1990 to 2014. We Birth defects from vaccines to HPV, varicella, measles/mumps/rubella, and anthrax vaccines were excluded.  Of 50 reports of major birth defects; in 28 reports, the vaccine was given during the first trimester. Birth defects accounted for 3.2% of pregnancy reports with no unusual clusters or specific birth defects.

The Ribavirin Pregnancy Registry: An Interim Analysis of Potential Teratogenicity at the Mid-Point of Enrollment. 

Drug Saf. 40:1205-1218 (2017)

Ribavirin is associated with significant teratogenic effects in all animal species and is contraindicated in women who are pregnant and male partners of pregnant women. Since 2003, the Ribavirin Pregnancy registry birth defect cases have been recorded for 7/85 directly exposed women (8.2%) and 4/95 indirectly exposed women (4.2%). With no consistent patterns. Thus, preliminary findings do not suggest a clear signal of human teratogenicity for ribavirin although current sample size is insufficient to change current guidelines.