From the Guidelines
Motilium (Domperidone) should be avoided during the first trimester of pregnancy due to limited safety data and the availability of alternative medications with better established safety profiles. The provided evidence does not directly address the safety of domperidone during pregnancy, but it discusses the safety of other medications used to treat nausea and vomiting, such as metoclopramide and ondansetron 1. While metoclopramide has been shown to not significantly increase the risk of major congenital defects, the evidence for domperidone is lacking. In the absence of clear evidence, it is prudent to exercise caution and recommend alternative treatments.
Some key points to consider when evaluating the safety of medications during pregnancy include:
- The potential risks of congenital defects associated with certain medications, such as ondansetron, which has been linked to a marginal relative increase in cleft palate and cardiovascular malformations 1
- The importance of using medications with established safety profiles, such as metoclopramide, which has been shown to not significantly increase the risk of major congenital defects 1
- The need to weigh the benefits and risks of medication use during pregnancy, particularly during the first trimester when organ formation occurs
In the case of domperidone, the lack of clear evidence regarding its safety during pregnancy, combined with the availability of alternative treatments, suggests that it should be avoided during the first trimester. If treatment for nausea and vomiting is necessary during this time, other medications with better established safety profiles should be considered as first-line options. Healthcare providers should carefully evaluate the potential benefits and risks of domperidone use during pregnancy and discuss these with their patients. Any woman who has taken Motilium during early pregnancy should discuss this with her healthcare provider, but should not panic as no clear evidence of harm exists 1.
From the Research
Safety of Motilium (Domperidone) During Pregnancy
- The safety of Motilium (Domperidone) during the first trimester of pregnancy is a concern for many pregnant women and their healthcare providers.
- According to a study published in 2013 2, domperidone does not appear to be a major human teratogen, and fetal outcomes were similar in women taking domperidone and those not exposed to any potential teratogenic agent.
- The study found that there were three babies born with malformations in each group, with an odds ratio (OR) of 0.6 (95% CI 0.1,2.8), suggesting that domperidone may not increase the risk of congenital malformations.
- However, the study notes that the findings require further confirmation in larger studies.
Comparison with Other Medications
- A study published in 2017 3 found that metamizole (dipyrone) exposure in the first trimester does not seem to bear a substantial teratogenic risk, with a similar rate of major birth defects in the exposed and comparison cohorts.
- Another study published in 2009 4 found that exposure to folic acid antagonists during the first trimester of pregnancy is associated with an increased risk of congenital malformations, particularly neural tube and cardiovascular defects.
- A study published in 2013 5 found that there are critical gaps in information about fetal risk for many medications commonly used during pregnancy, including domperidone.
Limitations of Current Evidence
- The current evidence on the safety of Motilium (Domperidone) during pregnancy is limited, and more studies are needed to fully characterize the fetal risk.
- The study published in 2013 2 had a small sample size and requires further confirmation in larger studies.
- The studies published in 2017 3 and 2009 4 provide some insight into the safety of other medications during pregnancy, but the findings may not be directly applicable to domperidone.