Proton Pump Inhibitors (PPIs) have been being linked to heart birth defects, when taken by women in the first trimester of pregnancy, according to a recent study. Popular PPIs include Aciphex (rabeprazole), Nexium (esomeprazole), Prevacid (lansoprazole), Prilosec (omeprazole), and Protonix (pantoprazole).
Researchers found that mothers’ use of PPIs to help pregnancy-related gastroesophageal reflux disorder (GERD) was associated with a two-fold risk of giving birth to babies born with heart malformations, said Andrew D. Rhim, MD, of the University of Pennsylvania, and colleagues, wrote MedPageToday. The same might apply for alternative antacids.
“We feel that our data … can have a large public health impact given the fact that GERD is so common during pregnancy,” Rhim said. Congenital heart malformations are considered rare, he noted, wrote MedPageToday. Findings were reported at a press conference at Digestive Disease Week last year.
Acid reflux is fairly common during pregnancy, with about half of all pregnant women experiencing GERD and physicians, more-and-more, prescribing popular PPIs, which, as a class, block stomach acid release, explained MedPageToday. Because the safety of PPIs when used during pregnancy was not established, the researchers conducted the large, population-based study to learn if PPI exposure during pregnancy is linked to increased cardiac birth defects in babies, said MedPageToday.
The team looked at information from The Health Improvement Network (THIN) database, which maintains data from general practitioners in the United Kingdom, explained MedPageToday. Data from 2000 to 2008 was collected and a “nested, case-control analysis,” which matched babies with heart defects and controls, was conducted, MedPageToday explained. Of 208,951 pregnancies, 2,445 babies were born with cardiac malformation; these cases were matched with 19,530 controls.
The team reviewed H2 receptor agonists, another class of anti-reflux drugs approved before PPIs, and learned that these medications increased risks for cardiac malformations in newborns, said MedPageToday. Medications include Tagamet (cimetidine), Pepcid (famotidine), Axid (nizatidine), and Zantac (Zantac) and block histamine receptors in the stomach’s acid-producing cells, said MedPageToday. According to Rhim, this finding, “complicates matters,” noting that so-called “conservative management,” such as consuming smaller meals, does not always help.
We’ve long noted that PPIs have been linked to fractures of the hip, spine and wrist; an increased risk of serious infections such as pneumonia and C. difficile diarrhea; and severe magnesium deficiency, which can cause life-threatening cardiac arrhythmias. While these and other serious side effects are listed in the fine print of the drugs’ labels, none are given prominence via a black box warning.
Recently, consumer watchdog, Public Citizen, petitioned the U.S. Food & Drug Administration (FDA) to require manufacturers list serious adverse reactions linked with PPIs in a prominent black box warning on their labels. According to the group, evidence shows that after using PPIs for a month or more, patients who stop taking the drug make even more stomach acid than before they started, a phenomenon known as rebound acid hypersecretion. This causes acid reflux symptoms to return even worse than before therapy, and patients begin taking the drugs again, leading to long-term dependency.