Prilosec Heart Attack Injury Risk

The journal PLOS One published a study by the Stanford Center for Biomedical Informatics examining whether heartburn medications such as Prilosec are linked to an increased risk of heart attacks. Prilosec is a proton pump inhibitor, which is a type of medication that is used to  reduce the amount of acid the glands in the stomach produces, reducing heartburn as a result.

Data collected from electronic records found a 16 to 21 percent increase in the risk of myocardial infarction, more commonly known as a heart attack, in the general population.

Proton pump inhibitors have been an incredibly popular drug, among the top prescribed medications for over a decade. Proton pump inhibitors are among one of the most widely prescribed classes of medication, an estimated $14 million in sales are generated each year from sales. Prilosec can be obtained through a prescription and over the counter.

About Prilosec

Prilosec is also known by the generic name omeprazole. Prilosec OTC is manufactured by Procter & Gamble, a multinational company the produces a wide range of household and pharmaceutical products and boasts of quality as their main goal. The prescription version of Prilosec is manufactured by AstraZeneca, a biopharmaceutical company which has operations in over 100 countries.

The FDA indicates Prilosec for use as a treatment for gastroesophageal reflux, or GERD. Individuals with GERD experience heartburn and sometimes injury of the esophagus due to glands in the stomach producing too much acid. Prilosec is a once a day pill, taken at least an hour before a meal. See also Prevacid vs Prilosec vs Nexium Which Is Worst?

According to a report by CBS, sales of both Prilosec OTC and Prilosec are not what they once were. Over the counter heartburn medication is becoming a crowded market, and Prilosec has steadily dropped in sales since they peaked at $387 millien in 2006. Additionally, Nexium is more widely paid for by insurers, making it a the preferred prescription heartburn pill of Prilosec.

The following chart shows the decrease in Prilosec sales over the last three years, as outlined by the AstraZeneca 2013 Annual Report:

Prilosec Side Effects

There are some mild side effects commonly associated with Prilosec, these include nausea, gas, diarrhea, vomiting, stomach pain, and headache.

There are some less common side effects associated with Prilosec which are more severe. Individuals experiencing the following side effects should seek medical attention:

• signs of an allergic reaction such as swelling, hives, rash, and trouble breathing
• persistent diarrhea, watery or bloody diarrhea, or severe stomach pains
• seizures
• rapid weight gain, urinating more or less frequently, swelling, blood in urine or other symptoms. See kidney disease & failure lawsuits.
• tremors, loss of muscle control, dizziness, irregular heart rate, coughing or choking feeling, confusion, or other symptoms of low magnesium levels.

Prilosec Increases Risk of Heart Attack

An increased likelihood of heart attack was found in individuals taking proton pump inhibitors,such as Prilosec,  in a study performed by the Stanford Center for Biomedical Informatics. This study estimated that each year approximately 113 million proton pump inhibitor prescriptions are filled globally. One of the big concerns associated with PPIs is that they can be bought over the counter and without the oversight of a medical professional.

About the research method used for the study

2.9 million individuals were studied using information stored in two databases containing approximately 16 millions electronic clinical documents collectively. Data on individuals treated for GERD between the years 1994 and 2012 were pulled from these databases to compile the study. This method of searching and analyzing data stored electronically is called data-mining.

This study cannot be considered an epidemiological study due to some key differences between data-mining and an epidemiological study. Cause can be determined in an epidemiological study because researchers are able to control for different variables which could skew the results of the study. In contrast, data-mining can only achieve proving a correlation between two sets of data.

In this particular study, researchers used data-mining to discover a positive correlation between myocardial infarction incidents and proton pump inhibitor prescriptions. The main limitation of this study is that correlation does not prove PPIs as the cause of an increased risk of heart attacks in the studied patients.

About the population of individuals studied

Patients previously diagnosed and treated for GERD, who were at least 18 years old, were selected to create the population of this study. These individuals were then divided into two groups. These two groups were patients prescribed proton pump inhibitors and patients prescribed H2-blockers, a commonly prescribed class of medication used in the treatment of ulcers and heartburn.

Patients taking a proton pump inhibitor comprised 45.9% of the population, and can be broken down by specific medication as follows:

18% of the studied population was made up of patients prescribed H2-blockers as treatment for heartburn or ulcers. Clopidogrel, a blood thinner used to prevent stroke, heart attack, and other heart condition among an at risk population, made up 6% of the studied group.

Because of previous research which indicated that PPIs cause clopidogrel to become ineffective, this groups of individuals were excluded from the group. Researchers felt they could get the clearest understanding of how PPIs affect the risk of heart attack if they removed this at-risk population from their research.  The group of individuals prescribed an H2-blocker accounted for 18% of the entire population studied.

Results of the Study

An increased risk of a myocardial infarction, or heart attack, was found to be associated with taking proton pump inhibitors. Research performed in this study found that individuals prescribed drugs such as Prilosec saw an increase in risk by 16 to 21 percent.

However, in the group who had been prescribed H2 blockers, there was no found increased risk of heart attack. Research results were obtained aside from other risk factors, such as those related to age and acute coronary syndrome. Acute coronary syndrome, or ACS, causes an abrupt decrease of blood flow to heart, increasing the risk of heart attack, according to the Mayo Clinic As previously mentioned, the results of this study also excluded those prescribed clopidogrel.

Research results appear to be applicable to the general population, and do not vary with age. Researchers explained that previously performed researched seemed to point to PPIs increasing ADMA levels in the plasma, which causes an increase in risk of cardiovascular problems. Still, researchers admit that the cause of this increased risk is not actually clear and call for additional research in the future. See also The Latest Prilosec Recall News

Limitations of this study, according to the researchers, include the fact that there may have been competing factors and undocumented variables which influenced the data pulled from electronic records. Also, it may be true that the studied population could be considered to be unwell and already at greater risk for a myocardial infarction.

Even so, there is reason to be concerned about the effects of Prilosec on the general population. In order to get a better idea of the risks associated with PPIs, researchers hope to perform additional research. Meanwhile, the cautioned consumers about the suggested increase of risk factors found by their study.

Other Risk Factors Associated with Prilosec

Additional risk factors linked with Prilosec use, along with other proton pump inhibitors, have been previously researched. According to a warning by the FDA, patients prescribed clopidogrel should avoid taking PPIs because they are known to reduce the effectiveness of this medication which is taken to reduce the risk of stroke, heart attack, and other heart conditions.  Additionally, based on the belief that PPI users experience worsening heartburn symptoms after discontinuing use of the medication, an advocacy group tried to get the FDA to place a black box warning on proton pump inhibitors.

Consumer Warning

According to Nicholas Leeper, one of the authors of this study, consumers should be cautious about taking Prilosec and other proton pump inhibitors for heartburn relief. In an interview with the The New York Times he suggested that patient should weigh the benefits and risks associated with taking this medication. Patients looking for gastroesophageal reflux treatment options should consult with their doctor before beginning use of proton pump inhibitors. See also Prilosec Class Action Lawsuit