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Proton Pump Inhibitor Birth Defect Lawsuit
Proton-pump inhibitors (PPI) are a group of drugs that reduce gastric acid production. They are available by prescription and over-the-counter. They are very similar in action and there is no evidence that one is more effective than another. The effects of some PPIs are may last longer, and therefore, be taken less frequently. The Food and Drug Administration advises that no more than three 14-day treatment courses should be used in one year. PPIs are used in the treatment of conditions, such as:
• Peptic ulcer disease
• Gastroesophageal reflux disease (GERD)
• Barrett’s esophagus
• Eosinophilic esophagitis
• Stress gastritis prevention
• Laryngopharyngeal reflux
More than half of pregnant women experience heartburn. Heartburn occurs when the valve between the stomach and the esophagus are unable to keep the stomach acids from passing back into the esophagus. During pregnancy, the hormone progesterone causes the valve to relax, which allows the stomach acids to pass back into the esophagus and irritate the linings. Physicians usually try to use diet and behavior modification to treat the symptoms of GERD, however, these methods are often ineffective, causing physicians to increasingly prescribe PPIs. Some of the drugs suggested or prescribed to relieve the symptoms include:
They are among the most widely sold drugs in the world, and are generally considered effective, although not much was known about their safety during pregnancy. Because heartburn can be severe and damaging to the quality of life, Penn researchers stress that patients and physicians need to weigh the benefits and possible risks of PPIs on a case-by-case basis. They also suggest that H2 receptor antagonist anti-reflux medications be considered first during pregnancy to minimize potential risks.
Some of the adverse effects are the elevated risk of developing food allergies, developing drug hypersensitivity, and the development of asthma in children whose mother was exposed to acid-suppressive drugs during pregnancy. Unfortunately, childhood asthma is not the only illness pregnant women should be concerned about. According to Andrew D. Rhim, MD, of the University of Pennsylvania and his colleges, maternal use of PPI’s to relieve symptoms of pregnancy-related gastroesophageal reflux disorder (GERD) was tied to a two-fold risk of babies being born with heart malformations. This is particularly concerning to women who take PPIs in the four weeks leading up to pregnancy and during the critical first trimester, when the fetus’s heart tube is forming and the heart beats for the first time. There are numerous birth defects that may be associated with PPIs, including:
• Atrial septal defects
• Ebstein’s Anomaly
• Hypoplastic right heart sysndrome
• Truncus Arteriosus
• Hypoplastic left heart syndrome
• Total Anomalous Pulmonary Venous Return
• Tetralogy of Fallot
• Conotruncal Heart Defect
• Coarctation of the aorta
In 2001, a study of 995 women who used Prilosec during their pregnancy revealed that five infants born to mothers in the sample group were stillborn, and that overall, there was a possible increase in birth defects.
In 2010, although neither could conclusively prove that the drugs caused birth defects; two studies did raise concerns about the use of PPIs in expectant mothers. Of all the PPIs researched looked at, omeprazole was associated with the greatest increase in the risks for having a baby with a cardiac defect. In several early trials of Prilosec, there was an increased incidence of ventricular septal defects.
The NEJM study is the largest to date and included more than 840,000 births in Denmark between 1996 and 2008. The study showed that 3.4% of the women who took the proton pump inhibitors had infants who had major birth defects. In the women who didn’t take the drugs, 2.6% had infants who had birth defects.
Despite early signs that PPIs may be dangerous to take during pregnancy, no pharmaceutical company has designed a study to follow up on the potential risks, even though half of all women experience chronic heartburn during pregnancy and many are prescribed PPIs.
Having a baby should be a joyous occasion; a time to celebrate the beginning of a new life. Unfortunately, some parents’ moments of joy turn to times of sorrow due to birth defects caused by medications taken during pregnancy. Birth defects can cause premature death, or physical and/or mental impairment. This is a fate some parents have to struggle through due to PPIs taken during pregnancy.
Although some birth defects are not avoidable, some are. In situations such as these, it is important to protect the legal rights of the baby and the parents. If you were pregnant and took a PPI under the guidance of a physician, you may have a claim against the drug manufacturer. There have been numerous suits taken against the manufacturers of the drugs: Takeda (Prilosec), TAP Pharmaceuticals (Prevacid), AstraZeneca (Nexium), Wyeth (Potonix), and the manufacturers of the generic versions of Aciphex.