Oxycodone is a semisynthetic opioid analgesic administered orally, intramuscularly or intravenously for the treatment of moderate to severe pain.
There is no indication that maternal therapeutic use of oxycodone in early pregnancy increases overall congenital malformation rates in exposed offspring, but the available data are not sufficient to exclude an increase in risk. One small study assessed the risk of miscarriage and found no evidence of an association with maternal therapeutic oxycodone exposure. One study, with at least 2,000 exposed pregnancies assessed for each outcome, found that oxycodone exposure in the first and second, but not the third trimester, was associated with a small increased risk of preterm delivery (absolute risk ~10% vs. background risk ~7%). However, it is unclear whether residual data confounding may have contributed to this finding, particularly as later pregnancy exposures are generally thought more likely to influence preterm delivery risk. In the same study, exposure in any trimester was not associated with either stillbirth or SGA infants. No studies have assessed neurodevelopmental outcomes or rates of childhood cancer in the offspring following maternal use of oxycodone.
Use of any opioid during pregnancy, particularly around the time of delivery, confers a risk of neonatal respiratory depression and neonatal withdrawal, both of which have been described following in utero oxycodone exposure. Exposed infants should be delivered in a hospital setting and monitored for these effects.
Where oxycodone poisoning occurs in pregnancy, maternal toxicity is likely to be a major factor in determining any risk to the fetus. However, due to a lack of sufficient poisoning in pregnancy exposure data, an increased risk of adverse outcomes in the absence of maternal toxicity cannot currently be excluded. If use of an antidote (e.g. naloxone) is required in the management of maternal toxicity it should not be withheld on account of pregnancy.
Exposure to oxycodone at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments. Enhanced fetal monitoring may be warranted during instances of maternal toxicity
This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.
If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.
If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.