Non-steroidal anti-inflammatory drugs (NSAIDs) are used to treat pain and inflammation in various disease states.
Although use of NSAIDs in pregnancy has been associated with an increased risk of miscarriage, malformation (including specific defects, such as cardiovascular defects, septal cardiac defects and orofacial clefts), preterm delivery and fetal growth impairment, the available evidence is often conflicting, is considered likely confounded, and may have also been influenced by methodological limitations. Causal relationships between NSAID use in pregnancy and these outcomes are therefore considered unproven.
The available data on NSAID use in pregnancy do not suggest an association with stillbirth or attention problems in the child.
Exposure to NSAIDs after 20 weeks of gestation has been associated with an increased risk of premature closure of the ductus arteriosus (DA) and oligohydramnios. These effects are thought to be mediated by the inhibitory effect of NSAIDs on prostaglandin production and fetal renal toxicity. There are conflicting findings regarding an increased risk of persistent pulmonary hypertension of the newborn (PPHN) following antenatal use of NSAIDs. Further evidence is therefore required. A potential class effect for these associations should be considered for all NSAIDs where published data concerning the fetal effects of gestational exposure to a specific NSAID are unavailable.
All NSAIDs should, where possible, be avoided after 20 weeks of pregnancy. In circumstances where the maternal clinical condition requires short-term treatment (such as acute short-lived pain: post-operative, dental, skeletal injury), this should be limited to the shortest duration possible whilst using the lowest effective dose. There is currently no evidence-based guidance about how long use should be restricted for, but pragmatic advice is to limit use to no longer than three days. Longer-term use, for example for treatment of chronic arthritis, or any use in the third trimester (28 weeks of gestation or beyond), should be avoided. As fetal urine production begins at approximately 10 weeks’ gestational age, referral to a Fetal Medicine Unit for monitoring of DA patency and oligohydramnios is recommended following prolonged NSAID use after the first trimester.
Other risk factors may also 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. Discussion with UKTIS is recommended for all cases of NSAID exposure in pregnancy.
For information on specific NSAIDs please refer to the appropriate monograph, where available.
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.