Safety of medication use during pregnancy and breastfeeding

Preko dvije trećine žena konzumira lijekove tijekom trudnoće, a otprilike polovina trudnica nije planirala trudnoću pa se u ranom i najosjetljivijem razdoblju fetalnog razvoja nerijetko javlja izloženost brojnim lijekovima. Proizvođači lijekova ne ispituju lijekove na trudnicama jer se to smatra neetičnim pa se procjena potencijalnih rizika primjene lijeka za majku i nerođeno dijete temelji na studijama provedenim na životinjama, muškarcima te ženama koje nisu trudne, na djelovanju drugih lijekova sa sličnim farmakokinetskim osobinama koji imaju poznate nuspojave, na podacima o primjeni lijekova od strane trudnica dok još nisu znale da su trudne ili su imale indikaciju za primjenu lijeka unatoč riziku te na registrima trudnoća i urođenih mana. Prema navedenim podacima, FDA je još 1979. godine razvila klasifikaciju rizika primjene određenih lijekova u trudnoći, a 2015. godine su kategorije zamijenjene narativnim opisima koji se odnose na rizike u trudnoći, porodu, dojenju te rizike za reproduktivni sustav muškaraca i žena. Dojam da posteljica čini nepropusnu barijeru lijekovima, danas se naširoko smatra zabludom. Pokazalo se da gotovo svi lijekovi koji se daju u trudnoći u određenoj mjeri ulaze u cirkulaciju fetusa. Negativni učinci izloženosti lijeku u trudnoći mogu se manifestirati kao gubitak trudnoće, teratogenost, fetotoksičnost, nuspojave u novorođenčeta te odgođene nuspojave u djeteta u razvoju. Najčešće korišteni lijekovi u dojilja relativno su sigurni za dojenčad. Doza lijeka koju dojenče prima preko majčinog mlijeka općenito je mala i puno manja od poznatih sigurnih doza koje se inače daju novorođenčadi i dojenčadi. Štetni učinci nakon izlaganja lijekovima iz majčinog mlijeka uglavnom su neposredni, poput sedacije i iritacije dojenčeta te gastrointenstinalnih tegoba. Preko 50% žena tijekom trudnoće koristi analgetike, 50-80% trudnica pati od mučnine, oko 50% i od povraćanja, a gotovo četvrtina žena prima antibiotike u trudnoći stoga je farmakološka terapija često neizostavan dio u trudnoći i dojenju.ver two-thirds of women consume drugs during pregnancy, and approximately half of pregnant women did not plan to become pregnant, so in the early and most sensitive period of fetal development exposure to numerous drugs often occurs. Drug manufacturers do not test drugs on pregnant women because it is considered unethical, so the assessment of the potential risks of using the drug for the mother and the unborn child is based on studies conducted on animals, men and women who are not pregnant, on the effects of other drugs with similar pharmacokinetic properties that have known side effect, on the data on the use of drugs by pregnant women before they knew they were pregnant or had an indication for the use of the drug despite the risk, and on the registries of pregnancies and birth defects. According to the above data, the FDA developed a classification of the risks of using certain drugs during pregnancy as early as 1979, and in 2015 the categories were replaced by narrative descriptions related to risks in pregnancy, childbirth, breastfeeding and risks to the reproductive system of men and women. The impression that the placenta forms an impermeable barrier to drugs is now widely considered a misconception. It has been shown that almost all drugs administered during pregnancy enter the fetal circulation to some extent. Negative effects of drug exposure during pregnancy can manifest as pregnancy loss, teratogenicity, fetotoxicity, side effects in the newborn and delayed side effects in the developing child. The most commonly used drugs in nursing mothers are relatively safe for infants. The dose of the drug received by the infant through breast milk is generally small and much lower than the known safe doses normally given to newborns and infants. Harmful effects after exposure to drugs from breast milk are mostly immediate, such as sedation and irritation of the infant and gastrointestinal complaints. Over 50% of women use analgesics during pregnancy, 50-80% of pregnant women suffer from nausea, about 50% also from vomiting, and almost a quarter of women receive antibiotics during pregnancy therefore, pharmacological therapy is often an indispensable part of pregnancy and breastfeeding