There is no evidence so far that two popular heartburn drugs Prilosec (omeprazole) and Nexium (esomeprazole) can cause cardiovascular risks like heart attacks, heart failure, and heart-related sudden death, the US Food and Drug Administration has revealed. 

In a sudden and surprise announcement, the FDA said it had received data from AstraZeneca, the manufacturer of Prilosec (omeprazole) and Nexium (esomeprazole). This data pointed to two small studies in patients with severe gastroesophageal reflux disease (GERD). Preliminary findings appeared to point to increased risk of heart attacks and heart failure in patients who took these drugs rather than opt for surgery.

"After initial review and analysis of all the available data from the studies, the FDA's preliminary conclusion is that, collectively, these data do not suggest an increased risk of heart problems for patients treated with Prilosec or Nexium. Therefore, health care providers or patients should not change either their prescribing practices or their use of these products at this time", FDA said in a statement.

Prilosec and Nexium are members of a class of drugs called proton pump inhibitors (PPIs). These drugs work by reducing the acid secretion in the stomach, which is the main cause of GERD or heartburn. Nearly one billion people worldwide have made the drugs as a part of their treatment.

According to the National Institutes of Health, "Gastroesophageal reflux disease (GERD) is a more serious form of gastroesophageal reflux (GER), which is common. GER occurs when the lower esophageal sphincter (LES) opens spontaneously, for varying periods of time, or does not close properly and stomach contents rise up into the esophagus."

"The main symptom of GERD in adults is frequent heartburn, also called acid indigestion—burning-type pain in the lower part of the mid-chest, behind the breast bone, and in the mid-abdomen."

Drugs called proton pump inhibitors or heartburn drugs are usually taken to relieve the problem. Proton pump inhibitors are favored over other drugs such as H2 blockers since they are able to completely heal the esophageal lining as well as provide relief from burning-type symptoms associated with GERD.

The FDA had carried out efficacy study of different drugs used in the treatment of GERD. The data acquired during the study pointed out to a possible long term cardiac risks which included heart-related sudden death, in patients who were consuming either Prilosec (omeprazole) or Nexium (esomeprazole).

The associate director of Office of Safety Policy and Communication at the Center for Drug Evaluation and Research, Dr Paul Seligman revealed that the agency had carried out a series of internal meetings when the first reports surfaced that the drugs could increase long term cardiac risk.

British pharmaceutical company AstraZeneca, who is the manufacturer of both the drugs, the released a detailed data to the FDA which included a 14-year long study that compared the drug with a placebo. FDA found that patients taking Prilosec had a lower risk of heart failure compared to those who were on a placebo. It also revealed that there was no increased risk among patients who consumed Nexium compared to those patients who underwent surgery.

However FDA agreed that even though the study had collected safety data during the period of the trial, there was no clear definition of heart related problems, such as heart attacks, thus making it difficult for the agency to evaluate the information. Dr Seligman revealed that while the agency will continue to conduct a detailed study of the drugs, it released the preliminary information so as to keep up with FDA's policy of informing the public of possible safety issues to their health.

Some of the important points to be known about GERD (Source: NIH)
*Frequent heartburn, also called acid indigestion, is the most common symptom of GERD in adults. Anyone experiencing heartburn twice a week or more may have GERD.

*You can have GERD without having heartburn. Your symptoms could include a dry cough, asthma symptoms, or trouble swallowing.

*If you have been using antacids for more than 2 weeks, it is time to see your health care provider. Most doctors can treat GERD. Your health care provider may refer you to a gastroenterologist, a doctor who treats diseases of the stomach and intestines.

*Health care providers usually recommend lifestyle and dietary changes to relieve symptoms of GERD. Many people with GERD also need medication. Surgery may be considered as a treatment option.

*Most infants with GER are healthy even though they may frequently spit up or vomit. Most infants outgrow GER by their first birthday. Reflux that continues past 1 year of age may be GERD.

*The persistence of GER along with other symptoms—arching and irritability in infants, or abdominal and chest pain in older children—is GERD. GERD is the outcome of frequent and persistent GER in infants and children and may cause repeated vomiting, coughing, and respiratory problems.