Popular Morning Sickness Drug Safe in Pregnancy: Study
Women taking metoclopramide can be reassured by the findings, expert says
The drug has FDA approval for use as a treatment for patients suffering heartburn and esophagitis due to acid reflux. It's also used to treat nausea caused by surgery or chemotherapy, and is often recommended as a treatment for morning sickness if other therapies have failed.
Pasternak said there aren't many alternatives for the treatment of nausea and vomiting in pregnancy. "There appears to be some degree of individual variation in response to drug treatment, so some women may be helped by one drug and others by another. Therefore, different treatment alternatives are needed," he said.
In this study, researchers reviewed more than 1.2 million pregnancies in Denmark from 1997 to 2011 and compared outcomes between women who used metoclopramide and those who did not.
The investigators compared 28,486 infants exposed to metoclopramide in the first trimester of pregnancy to 113,698 unexposed infants, and found no associations between the nausea drug and any major malformations.
The study also found no increased risk of miscarriage, stillbirth, preterm birth, low birth weight or fetal growth restriction associated with metoclopramide use in pregnancy.
Because birth defects are rare, it can be difficult to assess a drug's safety in small-scale studies, Dolan said. A study looking at tens of thousands of pregnancies is more likely to find patterns and associations between a medication and the risk of birth defects, if such risk exists.
"We can take from this some reassurance" of metoclopramide's safety, Dolan said. "What's powerful about a study like this is they looked at all the births in Denmark between 1997 and 2011. That's a lot of births."
Regardless, Dolan said further study into the safety of this and other medications used during pregnancy will always be needed.
"We need good data to have good understanding so women can be cared for, and their symptoms can be treated and they can have successful pregnancy outcomes," she said. "Women need to understand the risks of any medication they choose to take."