Advocacy group petitions FDA to require cancer risk warnings on acid reflux medications

The Esophageal Cancer Action Network filed a citizen’s petition with the FDA, asking the agency to require labels on over-the-counter reflux medications to warn consumers about the association between persistent heartburn and esophageal cancer.

The advocacy group also wants labels to explain that over-the-counter reflux medications do not eliminate esophageal cancer risk.

“We know that millions of Americans are self-medicating when they experience heartburn and other symptoms of reflux,” Mindy Mordecai, CEO and founder of Esophageal Cancer Action Network (ECAN), told HemOnc Today. “The medications can be very effective at temporarily relieving those symptoms. Unfortunately, we also know that very few of those who experience these symptoms understand that reflux can cause cancer.”

Lack of awareness

Approximately 15 million Americans experience daily heartburn.

Persistent heartburn can be a symptom of gastroesophageal reflux disease, a condition in which stomach contents splash into the esophagus and produce cellular changes that can lead to cancer.

Only 14% of U.S. adults understand that acid reflux can cause cancer, according to an ECAN–commissioned market research survey of 1,000 Americans.

“This is of particular concern because the kind of cancer caused by reflux disease is the fastest-increasing cancer among men in the United States,” Mordecai said.

Approximately 3 million Americans have Barrett’s esophagus, a precancerous condition that can result in an approximate 125-fold increase in a person’s risk for esophageal cancer. However, more than half of those patients are unaware they have the condition because it causes no symptoms.

Incidence of esophageal adenocarcinoma, among the deadliest of cancers, has increased more than 600% since the 1970s. Only 18% of those diagnosed with esophageal cancer will survive 5 years because the disease typically is discovered at late stages, when treatment rarely is effective.

“The only early warning sign that many of those at risk for esophageal cancer will get are those symptoms of reflux disease,” Mordecai said. “Without awareness that they are at risk, no alarm goes off and patients take no action until it is too late. By the time they have a tumor large enough to block their esophagus, it is usually too late to do anything to save their lives.”

Warning label

Labels on over-the-counter reflux medications warn against long-term use. They also urge patients to seek physician recommendations before taking the medication for an extended period because “persistent heartburn may be a sign of a more serious condition.”

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However, there is no mention of cancer risk.

“The term ‘more serious condition’ does not give patients a full understanding of their risk,” Mordecai said. “[Patients] should be fully informed of the risk so that they can make the choice to see their doctor for more information. We would hope that would prompt them to seek an endoscopic examination of the esophagus to determine if they have esophageal cancer or its precursor, Barrett’s esophagus.”

The petition states that “warnings should include a stronger, bold and prominent statement that persistent heartburn can be a sign of increased risk of esophageal cancer and explain that drug products do not eliminate that risk.”

The petition proposed the warning labels:

Specify that persistent heartburn can indicate increased risk for esophageal cancer, and that over-the-counter medications will not eliminate that risk;
Urge individuals who have had heartburn for more than 3 months to ask their doctor before using these products; and
Encourage people to stop using these products and see their physician if heartburn continues or worsens, if they need to take the product for more than 14 days, or if they need to take more than one course of treatment every 4 months.

What’s next

The FDA is reviewing the petition and will respond directly to the petitioner, a representative of the FDA’s Center for Drug Evaluation and Research Trade Press told HemOnc Today.

“If the petition is approved, ECAN intends to ensure the warning label is properly implemented and that the public is made aware of the fact that the labels have been placed on these medications and why,” Mordecai said. It will be another opportunity for us to reach out to organizations and media across the country about the importance of awareness that reflux can cause cancer.”

Meanwhile, physicians can take a variety of actions.

“Helping patients understand that reflux can cause cancer is a huge first step,” Mordecai said. “The second step is helping patients — and even some medical professionals — become aware that reflux can cause symptoms other than heartburn, like a hoarse voice, persistent cough or sore throat, [or] choking upon laying down at night. We would also hope that they will be especially vigilant with patients who have a family history of Barrett’s esophagus or esophageal cancer, given the research that has confirmed a familial links in some cases.” – by Kristie L. Kahl

For more information:

Mindy Mordecai can be reached at Esophageal Cancer Action Network, P.O. Box 243, Stevenson, MD 21153.