Exposure to mirtazapine during pregnancy: a prospective, comparative study of birth outcomes.

BACKGROUND: Mirtazapine is a novel piperazinoazepine antidepressant, unrelated to any known class of antidepressants. Currently, apart from a few case reports and case series in the literature, there are no studies evaluating the safety of this drug during pregnancy. OBJECTIVE: To determine whether mirtazapine increases the risk for major malformations in newborns when used by pregnant women. METHOD: The study design was prospective, with 2 comparison groups: disease-matched pregnant women diagnosed with depression taking other antidepressants and pregnant women exposed to nonteratogens. The primary outcome was major malformations in neonates; secondary endpoints included spontaneous abortions, therapeutic abortions, gestational age at birth, and mean birth weight. Women were recruited from 5 teratogen information services in Toronto, Canada; Farmington, Conn., U.S.A.; Jerusalem, Israel; Rome, Italy; Sydney, Australia; and from the Drug Safety Research Unit in Southampton, United Kingdom. Women were recruited into the study from June 2002 to August 2005. RESULTS: We were able to follow 104 pregnancy outcomes in each drug group. There were 77 live births, 1 stillbirth, 20 spontaneous abortions, 6 therapeutic abortions, and 2 major malformations in the mirtazapine group. The mean +/- SD birth weight was 3335 +/- 654 g and the mean +/- SD gestational age at delivery was 38.9 +/- 2.5 weeks. Most (95%) of the women took mirtazapine in the first trimester, but only 25% of the women took it throughout pregnancy. The differences among the 3 groups were in the rate of spontaneous abortions, which was higher in both antidepressant groups (19% in the mirtazapine group and 17% in the other antidepressant group) than in the nonteratogen group (11%), but none of the differences were statistically significant. The rate of preterm births (prior to 37 weeks' gestation) was also higher in the mirtazapine group (10%) and in the other antidepressant group (7%) than in the nonteratogen group (2%). The difference was statistically significant between the mirtazapine group and the nonteratogen group (p = .04). CONCLUSION: Mirtazapine does not appear to increase the baseline rate of major malformations of 1% to 3%. However, the higher number of spontaneous abortions in the antidepressant groups confirms the higher rates of spontaneous abortions in pregnant women taking antidepressant medications found in previous studies.

The attitude of physicians toward cold remedies for upper respiratory infection in infants and children: a questionnaire survey.

Over-the-counter cold remedies are widely used for symptomatic relief of upper respiratory tract infections. The safety of these drugs is not well established in infants and their efficacy is questionable. Our aim was to study the attitude of family physicians and pediatricians toward the use of cold remedies in infants and children. A questionnaire was sent to 400 family physicians and 100 pediatricians randomly selected across Ontario. The overall response rate was 53.2%. Sixteen percent of family physicians recommended cold remedies for infants 0 to 6 months of age compared to 4% of the pediatricians (P = 0.01). For infants 6 to 12 months of age, the difference between pediatricians and family physicians persisted (14% and 38% of, respectively; P < 0.001). Despite that cold remedies are not proven to be effective and some safety issues are associated with their use in the pediatric age group, physicians still recommend them. Continuing medical education programs should address the issue.

Pregnancy outcome following high doses of Vitamin E supplementation.

The recommended dose of Vitamin E in human pregnancy is 22-30 mg/day. High doses of Vitamin E (>or=400 IU/day) have been shown to attenuate or even prevent the damaging effect of ethanol and diabetes on the fetus in experimental animal models. The Motherisk program prospectively enrolled, and followed-up on, 82 pregnant women exposed to high doses (>or=400 IU/day) of Vitamin E during the first trimester of pregnancy. Pregnancy outcome was compared to a matched control group. The study group (n=82) was exposed to Vitamin E at doses ranging from 400-1200 IU/day. There was one pregnancy with major malformation (omphalocele) in study group. There was an apparent decrease in mean birth weight (3173+/-467 g) in Vitamin E group as compare to control (3417+/-565 g; P=0.0015); however, there were no significant differences in rates of live births, preterm deliveries, miscarriages and stillbirths. Therefore, it is concluded that consumption of high doses of Vitamin E during the first trimester of pregnancy does not appear to be associated with an increased risk for major malformations, but may be associated with decrease in birth weight.

Marijuana use and breastfeeding.

QUESTION: One of my breastfeeding patients is using marijuana to combat chronic pain. Is it safe for her to breastfeed? ANSWER: Lactating mothers should refrain from consuming cannabinoids. Advising mothers to discontinue breastfeeding if they cannot stop using cannabinoids must incorporate the known risks of formula feeding. Cannabinoid exposure through milk has not been shown to increase neonatal risk, but there are no appropriate studies of this. In every case, nursing babies should be closely monitored.