A critical review of the reproductive safety of Leflunomide.

Leflunomide, an inhibitor of pyrimidine synthesis, is used for the treatment of rheumatic diseases, which are prevalent in women of childbearing age. Due to the very long half-life of the active metabolite, its mechanism of action and the teratogenicity observed in animal studies at doses similar to or lower than human therapeutic doses on a weight basis, it is recommended that women stop the treatment before conception and a drug elimination procedure be performed. However, unintended gestational exposures may occur, posing challenges in risk assessment.

The new biologics in pregnancy.

Growing numbers of women of reproductive age are prescribed new biological agents. This is resulting in more pregnancies exposed to these drugs. What are the new biologics (also referred to as biologicals) and what are their indications? How are they currently used in pregnant women? What are the concerns when treating pregnant women with biologics? What do we know about the reproductive safety of these agents? Current and future research is discussed.

Safety of tacrolimus in pregnancy.

Question: I have a 30-year-old patient who had a kidney transplant 2 years ago. She is now planning a pregnancy. She has been treated with tacrolimus since her transplant.

Safety of the newer class of opioid antagonists in pregnancy.

Question: I have a patient recently confirmed to be 6 weeks pregnant. For the past 6 months she has been treated for an opioid addiction with buprenorphine-naloxone combination. Should I be concerned about her exposure to this drug combination up to this point of the pregnancy? Should I switch her medication to methadone now that she is pregnant?

Answer: The limited data on buprenorphine exposure during pregnancy show no increased risk of adverse outcomes in the newborn.

Pregnancy outcome after methotrexate treatment for rheumatic disease prior to or during early pregnancy: a prospective multicenter cohort study.

Objective: High-dose methotrexate (MTX) exposure during pregnancy is associated with embryopathy. The teratogenic potential of MTX at dosages typically used in the treatment of rheumatic diseases remains uncertain. The aim of this study was to evaluate the risk of spontaneous abortion, major birth defects, elective termination of pregnancy, shortened gestational age at delivery, and reduced birth weight in women exposed to MTX.

Update on antidepressant use during breastfeeding.

Question: Many of my patients who are diagnosed with postpartum depression want to continue breastfeeding. How safe are the newer antidepressant medications during breastfeeding?

Answer: The newer antidepressants transfer into breast milk in low amounts and have not been associated with serious adverse events. Therefore, the antidepressant most effective for the woman should be considered.

Tdap vaccination during pregnancy to reduce pertussis infection in young infants.

Question: What is the basis for the new recommendations to vaccinate pregnant women against pertussis after the first trimester?

Answer: There have been outbreaks of epidemic proportions of pertussis, mostly among young infants who have not received sufficient passive immunity from their mothers. This strategy of vaccination during pregnancy aims at stopping these life-threatening epidemics.

The fetal safety of fluoxetine: a systematic review and meta-analysis.

Objective: Fluoxetine is the selective serotonin reuptake inhibitor (SSRI) with the longest clinical use. Published reports regarding its fetal safety are contradictory. We aimed to establish the fetal safety of the drug.

Maternal cocaine use during breastfeeding.

Question: In my practice several patients have struggled with cocaine abuse during their pregnancies. One woman, now postpartum, wants to breastfeed her infant. Despite being abstinent for the final few months of her pregnancy, I am concerned about the potential adverse effects on her child if she happens to relapse.

Smoking cessation therapy during pregnancy.

Question: Despite being highly motivated to quit, many of my patients struggle with smoking cessation during pregnancy. Can you comment on the current treatment options and discuss their safety and efficacy during pregnancy?

Answer: Given the considerable and well-documented adverse effects of antenatal smoking on mother and fetus, pharmacotherapy for smoking cessation should be considered. Available medications include nicotine replacement therapy, sustained-release bupropion, and varenicline.

Safety of azathioprine use during pregnancy.

Question: Quite a few of my female patients with rheumatic diseases and inflammatory bowel disease are using azathioprine. They are afraid to take a "cancer drug" during pregnancy. What is known about the risks?

Answer: An increasing body of evidence from prospective cohort studies suggests that azathioprine is safe for the fetus during pregnancy.

Herpes zoster during pregnancy.

Question: One of my pregnant patients, a 32-year-old woman (gravida 2, para 1), has a flare up of herpes zoster (HZ) at the T11 to T12 dermatomes. This virus, the varicella-zoster virus, causes chickenpox, which can be teratogenic. Is this also true for HZ?

Answer: Herpes zoster, unlike chickenpox, is not associated with increased fetal risk.

Safety of infliximab use during pregnancy.

Infliximab is a chimeric IgG1 monoclonal antibody to tumor necrosis factor alpha (TNF)-α used in the treatment of inflammatory bowel disease and rheumatoid arthritis. Infliximab does not actively cross the placenta during the first trimester, but undergoes efficient placental transfer during the late second and third trimesters and is detectable in the infant's serum for several months after birth. This raises concerns about immunological risks of infection and response to vaccines.

Drug exposure in pregnancy and heart defects.

Being the most common group of congenital malformations, congenital heart defects have often been investigated to rule out teratogenic effects by medicinal drugs and chemicals. Yet, the use of rigorous epidemiological methods has rejected such claims in many cases. We critically evaluate drugs believed to be associated with an increased risk of causing congenital heart defects, highlighting the debate and the practical implications of such associations.