Federal regulators said Thursday that they had opened a safety investigation of two popular heartburn drugs -- Nexium, widely marketed as the “purple pill,” and Prilosec, its older chemical cousin -- after receiving clinical data that appeared to link them to serious heart problems.
But the Food and Drug Administration emphasized that it had found no firm evidence of such a connection, and advised doctors and patients not to change medication practices. The agency promised a more complete answer within three months.
“At this time, FDA’s preliminary conclusion is that collectively these data do not suggest an increased risk of heart problems,” said an agency statement. “Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of these products at this time.”
The data were supplied to the FDA and drug regulators in other countries by AstraZeneca, maker of both medications. In a statement, the company said that based on all data available, Prilosec and Nexium “are not associated with an increased risk of cardiac events.”
Nonetheless, the FDA said it was notifying the public of the safety review in keeping with efforts to foster greater openness at the agency, which has been criticized for keeping a lid on problems with painkillers, antidepressants and, most recently, the diabetes drug Avandia.
Nexium and Prilosec are part of a family of drugs that reduce production of stomach acid. Intended to relieve chronic heartburn and acid reflux disease, which can damage the esophagus, they are also widely taken for routine stomach upset.
The two drugs have been taken by more than 1 billion patients worldwide. Many doctors believe such medications are overused, according to Consumer Reports.
Nexium was the sixth-most commonly prescribed brand-name drug last year, according to Drug Topics, an Internet magazine.
Prilosec is available over the counter, by prescription and in generic formulations. Prilosec OTC, the nonprescription version, had more than $360 million in sales last year, accounting for about one-third of the market for antacid tablets, according to Information Resources Inc., a Chicago-based marketing services firm.
The data that raised a caution flag came from a long-term clinical study on Prilosec and an ongoing study on Nexium that compared the drugs’ effectiveness with that of surgery in controlling severe gastroesophageal reflux disease. In people with the condition, the ring of muscle between the esophagus and the stomach does not work well, allowing gastric acid into the esophagus, a tube-like organ that delivers food to the stomach.
A higher number of patients taking either one of the drugs suffered heart attacks, heart failure or sudden heart-related death, the FDA said. But the studies involved only a few hundred patients, a relatively small number, and larger research studies showed no indication of heart problems.
In the study involving Prilosec, 17 patients taking the medication had serious heart problems, compared with eight in the group that had surgery, AstraZeneca said. However, the Prilosec patients appeared to have been in poorer health to begin with. Six of the Prilosec patients had had previous heart attacks, compared with none in the group that had surgery.