Two studies published by Am BMJ today no links are found between prescription opioids or macrolide antibiotics taken during pregnancy and risk of major birth defects.
Both opioids (painkillers) and macrolides (antibiotics) are often prescribed during pregnancy. Some previous studies have reported links between exposure to opioids and macrolides and some birth defects, but results are inconsistent.
Two studies published today aimed to address this uncertainty.
The first study included data for more than 82,000 U.S. women who received two or more prescriptions for any opioid during early pregnancy (first trimester) from 2000 to 2015.
After taking into account other possible risk factors, the researchers found no clinical increase in the risk of major birth defects overall, or in the form of heart defects, deficiencies. club foot or neural tube.
They found a slightly higher risk for palate cleft (four to five additional cases of palate cleft per 10,000 pregnancies exposed to opioids in the first trimester) and say clinicians should advise patients about this risk.
But overall, they say these findings show that pharmaceutical opioids used early in pregnancy are not associated with a significant increase in risk for most patients. types of malformation assessed.
In the second study, researchers in Denmark compared data for nearly 1.2 million pregnancies from 1997 to 2016 and found no link between exposure to macrolides early in pregnancy and risk of major defects birth.
Babies born with major birth defects occurred in 35 per 1000 pregnancies exposed to macrolides compared with 37 per 1000 pregnancies exposed to penicillin and 33 per 1000 pregnancies not exposed.
The results were not altered after further analysis of individual macrolides and specific birth defects by organ systems, suggesting that the conclusions are robust.
Both studies are speculative, so they cannot establish a cause, and relied on women taking the drugs as prescribed. In addition, the researchers are unable to find out that they may have missed some birth defects.
However, these were large studies using reliable medical insurance and national registration data, respectively, and were able to describe a range of other risk factors that may have influenced the results.
Thus, both research teams say their findings provide reassurance about the risk of major birth defects when opioids or macrolide antibiotics require treatment during pregnancy.
They also help inform clinicians, patients, and drug regulatory authorities about choosing medications for pregnant women and women of childbearing age who may be pregnant. .
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Peer review? there is
Type of evidence: Observation
Topics: Pregnant women
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