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Proton Pump Inhibitor Lawsuit
Doctors have used proton pump inhibitors (PPIs) for many years to treat stomach ulcers, gastro esophageal reflux disease (GERD) and heartburn. This category of drugs is very common and each year doctors write more than 113 million prescriptions just to treat this condition. However, studies have shown that when used for long period of time, the drugs can lead to an increase in the risk of fractures or birth defects.
What are the Drugs in this Class?
There are various drugs in this class that are prescribed by doctors, or sold over the counter. They include:
• Nexium: the generic name is esomeprazole magnesium. The FDA approved it in 2001 and it is manufactured by Astra Zeneca.
• Prevacid: This is a drug whose generic name is lansoprazole. It was approved by FDA in the year 2000 and is manufactured by Tap Pharmaceuticals.
• Prilosec: The FDA approved this in 2003. It is manufactured by Astra Zeneca.
• Protonix: This was approved by FDA in 2000 and is manufactured by Wyeth-Ayerst.
Other drugs include aciphex, dexilant and zegerid.
These drugs have been linked to an increased risk of fractures of the hip, wrist and spine as well as congenital malformation for children born of pregnant mothers who have used the drugs before.
We believe that thousands of people might have suffered broken bones while thousands of children have been born with birth defects as a result of these drugs. We also know that most victims of PPI- related side effects have no idea that these drugs played a role in their present situation.
If you broke your hip, wrist or spine after taking one of these drugs, we would like to hear from you. Additionally if you have a kid born with birth defects and you know that you used the drugs in the past, you also need to call us. This is because you might be entitled to compensations for your medical bills, lost wages, pain and suffering from the manufacturer of the drug. We are a team of lawyers who are ready to make sure you are compensated.
How do PPIs cause Fractures?
PPIs work by blocking the buildup of acid in the stomach. As they do this, it has been found that they also block the absorption of calcium, which may lead to a number of adverse side effects.
Bones require the body to absorb calcium for them to be strong. Lack of this means that the bones can easily break under a little pressure. This is why you find that fractures of the hip, wrist and spine is common in people who have taken PPIs for a long time.
PPIs and Birth Defects
PPIs are prescribed pregnant women to treat heartburn. This is a condition that affects 25 percent of all pregnant women. Despite the growing use of PPIs, the safety of these drugs in pregnancy has never been assured.
In 2001, a retrospective study was performed on 955 pregnant mothers whereby the mothers who used prilosec during pregnancy resulted in five stillborn children with a high risk of congenital birth defects.
The cardiac birth defects that are associated with PPIs include:
• Atrial septal defect (ASD): This is where a hole develops in the upper chambers of the baby’s heart.
• Coarctation of the aorta: This is where there is narrowing of the aorta, which prevents blood flow.
• Outflow tract defect.
• Ebstein’s anomaly: Here, the tricuspid valve, which is found between the right chambers of the heart, fails to form properly.
• Hypoplastic heart syndrome: This can occur on the left side of the heart or the right side. This is whereby the atrium or the ventricles on a particular side of the heart fail to develop completely. This results in one part of the heart not functioning properly.
• Tetralogy of Fallot: This combines four cardiac birth defects that occur at once. It consists of ventriculoseptal defect, overriding aorta, pulmonary stenosis and hypertrophy of the right hypertrophy.
• Total anomalous pulmonary venous return, here all the four pulmonary veins connect to the left atrium.
• Ventricle septal defect: There is poor development of one or more walls that separates the right and left ventricles of the heart.
• Truncus arteriosus: the baby is born with a large vessel instead of two that normally lead out of the heart.
What has the FDA said about these Risks?
The FDA approved all these drugs for use to treat GERD and other stomach disorders. However, this agency acknowledges the fact that prolonged use of PPIs can come at a price.
According to an FDA drug safety communication published in May 2010, people especially women over 50 years old are at high risk of PPIs if they had PPIs over a year.
According to this communication, six studies reported an increased risk of fractures of the wrist, spine and the hips for people who have taken PPIs for six months or longer.
The risk of PPIs was noted due to higher doses taken by the subject or longer duration of use. Due to this, the FDA announced that it was revising the safety levels for both prescription and over the counter PPIs to reflect this risk.
The FDA has also advised health care professionals and consumers to weigh the known benefits of PPIs against the potential risks when determining if these medications are appropriate for treatment.