PPIs, proton pump inhibitors, are a class of heartburn medications that includes Pilosec, Nexium, Prevacid, Protonix, and others. These medications are becoming increasingly common for controlling the frequency and intensity of heartburn during pregnancy. However, no real studies have been done to establish the safety of these medicines for use during pregnancy. Now, there is compelling information that these potentially dangerous drugs might be associated with an increased risk of cardiac birth defects.
In a poster abstract presented at the Digestive Disease Week Conference, researchers revealed preliminary results showing that PPIs double the risk of cardiac birth defects when used during the first trimester of pregnancy. Researchers reviewed data from nearly 209,000 pregnancies in the UK and examined the records of 2445 cases of cardiac birth defects, checking for PPI use. The data showed a doubled risk of cardiac birth defects, but was insufficiently powered to detect whether Prilosec, Nexium, Prevacid, or other PPIs were associated with higher risk than others.
Almost as if it had been sitting around, waiting to be published, a second study was released in November. This study, utilizing data from a Danish health registry, included nearly 841,000 pregnancies. The raw numbers at first seemed to hint that there may be a statistically significant increase in risk related to PPI use during pregnancy, but subsequent analysis seemed to dismiss this increase.
We don’t know whether PPI use during pregnancy is associated with an increased risk of cardiac birth defects, but we should. In several early trials of Prilosec, there seemed to be an increased incidence of ventricular septal defects, one of the more common cardiac birth defects associated with drug use. This showed up in a miniscule study of 113 women, and again in a small retrospective study of 955 pregnancies where the mother used Prilosec during pregnancy. The results, published in 2001, showed that five children were stillborn and overall there seemed to be an increased incidence of congenital heart defects. Oddly, the author concluded that “both effects may be random.” Apparently, this was considered to be the last word on the subject. Prilosec’s manufacturer, AstraZeneca, quoted this conclusion in its labeling for Prilosec, and there have not been sufficient follow-up studies to confirm or deny the association of Prilosec with cardiac birth defects. Other PPIs, such as Nexium, often just quote the data from Prilosec studies and refer to animal studies with the qualification that “animal reproduction studies are not always predictive of human response.”
With these hints, though, with thousands of prescriptions for the drugs being written for pregnant women every year, and, now, an over-the-counter version available, it seems criminal to simply ignore the question about whether these drugs can cause birth defects when used during pregnancy.
Drug companies have a responsibility to ensure their products are safe for use. If you used a PPI during pregnancy and your child suffered a birth defect, your pharmaceutical injury lawsuit can remind manufacturers of this responsibility. To learn more, please call or email Robert W. Kerpsack, CO, LPA today for a free initial consultation.