A study published on June 10th, 2015 in the journal PLOS One inspected the relationship between proton pump inhibitors such as Nexium, Prilosec, and Prevacid, and an increased risk of a myocardial infarction, more commonly known as a heart attack.
This study was a peer-reviewed study conducted by the Stanford Center for Biomedical Informatics. Proton pump inhibitors are typical taking by mouth to reduce the amount of stomach the glands in your stomach make, result in a decrease of heartburn symptoms. The results of this study found that proton pump inhibitors were correlated with an increased risk of a heart attack.
Data was collected from electronic records to create a sample representative of the general population. After analyzing this study, the researchers found that a 16 to 21 percent increase in risk of heart attack appears to associated with heartburn medication use.
Proton pump inhibitors, including Nexium, Prevacid, and Prilosec, are among the most popular prescription medications. According to this study, proton pump inhibitor prescriptions total approximately 113 million prescriptions each year. These drugs are also sold over the counter, and when combined with prescription sales, proton pump inhibitor sales total $13 billion annually.
Because proton pump inhibitors are so widely used, researchers feel there is reason to be concerned about the associated risks of using these drugs.
About Proton Pump Inhibitors
The most commonly prescribed proton pump inhibitors are:
- Nexium, which is the brand name for the generic drug esomeprazole
- Prilosec, which is the brand name for the generic drug omeprazole
- Prevacid, which is the brand name for the generic drug lansoprazole
Proton pump inhibitors are indicated by the FDA for gastroesophageal reflux treatment. This condition causes heartburn and occasionally damage to the esophagus because of too much stomach acid being produced by the glands in the stomach.
In 2014, sales of the top ten proton pump inhibitor prescription drugs make up $9.2 billion in U.S. prescription sales, according to IMS Health. This is a decrease in sales from 2010 by $12.3 billion. It is believed that the introduction of an over the counter Nexium product in 2014 explains this decrease since these numbers do not include over the counter sales.
According to IMS Health, proton pump inhibitors were third in sales when compared to other classes of medications:
Proton Pump Inhibitor Side Effects
There are a some minor side effects more commonly experienced when taking a proton pump inhibitor. These side effects include, nausea and vomiting, diarrhea, gas, and headache.
More serious side effects, which require medical attention, are less common and include:
- symptoms associated with an allergic reaction such as swelling, hives, rash, and troubled breathing.
- watery or bloody diarrhea and severe stomach pains
- kidney problems, which could be characterized by rapid weight gain, changes in frequency of urination, swelling, or blood in urine
- low magnesium levels which could be characterized by tremors, loss of muscle control, dizziness, irregular heart rate, coughing or choking feeling, or confusion
Proton Pump Inhibitors Increase Risk of Heart Attack
The Stanford Center for Biomedical Informatics published a study on June 10, 2015 stating a relationship was found between proton pump inhibitor use and an increase in myocardial infarction incidents.
Because an estimated 113 million proton pump inhibitor prescriptions are sold each year, in addition with the availability of proton pump inhibitor over the counter medications, this link is believed to be very concerning since these drugs are so widely available.
About the research method used for the study:
16 million electronic clinical documents where analyzed and data was collected on 2.19 million individuals. The data on these individuals was collected based on the fact that they had previously been treated for GERD between the years of 1994 and 2012.
A method called data-mining was used to obtain the results of this study. Data-mining is a method of searching and analyzing information stored in databases to create new information. One aspect of this study which is important, is and understanding of the differences data-mining has with an epidemiological study. Data-mining research was able to find a correlation, but not a cause due to an inability to control for other influencing factors and variables.
Epidemiological studies, however, are often able to find a causes because of the controls in place for influencing variables. In this study, this meant that researchers were able to see that a relationship between PPIs and an increased risk of heart attacks did appear to exists, but they couldn’t prove that PPIs caused heart attacks.
About the population of individuals studied:
All patients sampled were at least 18 years of age and had been treated with GERD in the past. The sample was divided into two groups, based on the type of treatment used. The first group had been treated with proton pump inhibitors, while the other group had been treated with H2-blockers, which are used to treat ulcers and heartburn.
Individuals prescribed proton pump inhibitors account for 45.9% of the individuals studied. This group was split according to the specific medication taken into the following percentages:
Within the group of individuals studied, 45.9% were taking a minimum of one type of proton pump inhibitor, and the percent of the population taking each individual medications (in generic form) is as follows:
|Percent of Sample|
18% of the group of patients had been prescribed H2-blockers as treatment for heartburn or ulcers. 6% of patients were also taking clopidogrel, a blood thinner used to prevent stroke, heart attacks, and other heart conditions. This groups was discluded from the results due the previous research which found that PPIs decrease the effectiveness of clopidogrel. This was done in order to get a clear look at the relationship between proton pump inhibitors and an increased risk of heart attacks.
Results of the Study
This study revealed an increased risk of heart attack by 16 to 21 percent to be associated with the use of PPIs such as Nexium, Prilosec, and Prevacid. However, in patients who were prescribed H2-Blockers, no increase in the risk of heart attacks was found.
Patients with age-related risks and those using clopidogrel were not included in this study and the results were achieved independently of these factors. Additionally, the added risk associated with elderly patients and acute coronary syndrome (ACS) did not influence the results of this study. ACS is a condition that causes an abrupt reduction of blood flow to the heart, increasing the risk of heart disease, according to the Mayo Clinic.
No variation was seen in the results of the study based on age, and the results did appear to be applicable to the general population. It isn’t clear what the exact cause of the increased risk of a heart attack is, but previous research suggests that an increase in ADMA levels, which can increase the risk of cardiovascular problem, may be occurring as a result of proton pump inhibitors.
Competing risk may have influenced the results of this study, according to the researchers. Another factor that was taken into consideration was that the patients selected may have been in poor risk, and may have already been at a higher risk for a myocardial infarction when compared to the general population.
This competing factors do not negate the need to be concerned about the possible side effects of proton pump inhibitors. Researchers strongly cautioned consumers concerning these risk factors and argued that additional research needed to be done in order to get a better understanding of these risks.
Other Risk Factors Associated with Proton Pump Inhibitors
The FDA has warned that, when proton pump inhibitors interaction with blood thinners such as clopidogrel, the effectiveness of clopidogrel in preventing stroke, heart attack, and other heart condition decreases. In 2011, and an advocacy group placed pressure on the FDA to include a black box warning on the packaged of PPIs. This was based on their belief that PPIs cause an increase in stomach acid production, causing GERD to become worse in the medication is discontinued.
Get Heartburn Medication Legal Help
Use the legal system to obtain fair compensation for your PPI damage claims and to obtain the justice you deserve. Consult us now to determine if you are eligible to either join an existing proton pump inhibitor lawsuit or file an individual lawsuit for damages due to use of PPI’s. You should not suffer physical harm, financial stress or other damage due to the negligent behavior of another person or company. We can Help!