FDA News

FDA petitioned to require esophageal cancer warning labels on OTC reflux drugs

The national nonprofit Esophageal Cancer Action Network filed a citizen petition asking the FDA to require new labels on over-the-counter reflux drugs warning about the risk for esophageal cancer associated with persistent reflux or GERD.

The petition has requested that the labels warn that OTC reflux drugs “do not eliminate the risk of esophageal cancer and a person should see their physician if they experience persistent heartburn associated with reflux disease, acid indigestion or sour stomach due to the risk of esophageal cancer.”

ECAN believes these warning labels are needed because patients are unaware of the risk for Barrett’s esophagus and esophageal cancer associated with GERD, and because OTC reflux drugs are so effective that many patients will not inform health care providers about their persistent heartburn.

“Existing warnings on anti-reflux medications are not sufficient to alert patients to the risk of esophageal cancer associated with persistent heartburn resulting from reflux disease, acid indigestion or sour stomach,” David Rosen, an attorney representing ECAN in its petition, said in a press release. “The FDA should act swiftly to include a bold prominent and strong warning label to better inform patients of the risks associated with persistent heartburn and the need to see their physician due to the risk of esophageal cancer that can go undetected if the patient is getting symptomatic relief from the OTC drug products.”

Up to 15 million Americans have daily heartburn, and esophageal cancer caused by GERD is the fastest growing cancer among men in the U.S., according to the press release. Heartburn may be the only early warning patients have of their risk for esophageal cancer, and once they develop an esophageal tumor that makes swallowing difficult, “treatment is rarely successful,” with fewer than one in five patients surviving 5 years after being diagnosed with esophageal cancer.

“So many of our patients tell us that they took over-the-counter heartburn medications for years, but never knew they were at risk for cancer — until it was too late,” John Lipham, MD, chairman of the ECAN board of directors and chief of Upper GI and General Surgery at University of Southern California, Los Angeles, said in a press release. “We know we can save lives with increased awareness and early detection.”

ECAN argues that many patients are diagnosed at such a late stage because they are unaware that GERD can cause esophageal cancer. A market research survey commissioned by the organization showed that only 14% of more than 1,000 adults in the U.S. were aware that reflux can cause esophageal cancer, according to the press release.

“We aren’t surprised by the numbers, but we are motivated to change them,” Mindy Mintz Mordecai, president and CEO of ECAN, said in the press release. “Folks need to know that if they are experiencing reflux symptoms on a regular basis, they should see their doctors and get checked — that’s why we filed our petition.”

The petition, signed by Mordecai and Lipham, proposes the following language for the warning labels:

“Persistent heartburn can indicate increased risk of developing esophageal cancer. This medication will not eliminate that risk. Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. Stop use of the product and see your physician if your heartburn continues or worsens; or if you need to take this product for more than 14 days; or if you need to take more than 1 course of treatment every 4 months.”

Disclosures: Mordecai and Lipham are affiliated with ECAN.

The national nonprofit Esophageal Cancer Action Network filed a citizen petition asking the FDA to require new labels on over-the-counter reflux drugs warning about the risk for esophageal cancer associated with persistent reflux or GERD.

The petition has requested that the labels warn that OTC reflux drugs “do not eliminate the risk of esophageal cancer and a person should see their physician if they experience persistent heartburn associated with reflux disease, acid indigestion or sour stomach due to the risk of esophageal cancer.”

ECAN believes these warning labels are needed because patients are unaware of the risk for Barrett’s esophagus and esophageal cancer associated with GERD, and because OTC reflux drugs are so effective that many patients will not inform health care providers about their persistent heartburn.

“Existing warnings on anti-reflux medications are not sufficient to alert patients to the risk of esophageal cancer associated with persistent heartburn resulting from reflux disease, acid indigestion or sour stomach,” David Rosen, an attorney representing ECAN in its petition, said in a press release. “The FDA should act swiftly to include a bold prominent and strong warning label to better inform patients of the risks associated with persistent heartburn and the need to see their physician due to the risk of esophageal cancer that can go undetected if the patient is getting symptomatic relief from the OTC drug products.”

Up to 15 million Americans have daily heartburn, and esophageal cancer caused by GERD is the fastest growing cancer among men in the U.S., according to the press release. Heartburn may be the only early warning patients have of their risk for esophageal cancer, and once they develop an esophageal tumor that makes swallowing difficult, “treatment is rarely successful,” with fewer than one in five patients surviving 5 years after being diagnosed with esophageal cancer.

“So many of our patients tell us that they took over-the-counter heartburn medications for years, but never knew they were at risk for cancer — until it was too late,” John Lipham, MD, chairman of the ECAN board of directors and chief of Upper GI and General Surgery at University of Southern California, Los Angeles, said in a press release. “We know we can save lives with increased awareness and early detection.”

ECAN argues that many patients are diagnosed at such a late stage because they are unaware that GERD can cause esophageal cancer. A market research survey commissioned by the organization showed that only 14% of more than 1,000 adults in the U.S. were aware that reflux can cause esophageal cancer, according to the press release.

“We aren’t surprised by the numbers, but we are motivated to change them,” Mindy Mintz Mordecai, president and CEO of ECAN, said in the press release. “Folks need to know that if they are experiencing reflux symptoms on a regular basis, they should see their doctors and get checked — that’s why we filed our petition.”

The petition, signed by Mordecai and Lipham, proposes the following language for the warning labels:

“Persistent heartburn can indicate increased risk of developing esophageal cancer. This medication will not eliminate that risk. Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. Stop use of the product and see your physician if your heartburn continues or worsens; or if you need to take this product for more than 14 days; or if you need to take more than 1 course of treatment every 4 months.”

Disclosures: Mordecai and Lipham are affiliated with ECAN.

    Perspective

    The society, ECAN, is asking the FDA to put labeling on PPI medication for reflux disease. This is an absolutely brilliant move because medication can lull the patient into a false sense of security. Patients take medication that makes them feel better but it actually is not changing their disease.

    The etiology of reflux is due to a defective lower esophageal sphincter, which remains defective and the reflux continues. When patients take medication, there’s less of the acid that’s coming up. The medication alters the concentration or the composition of what is refluxing, but it doesn’t stop the disease. Since reflux is associated with an increased risk of conditions that are precancerous like Barrett’s esophagus, or cancer of the esophagus, it essentially lulls you into a false sense of security that you’re doing well when, in fact, your reflux continues and your risk remains unchanged.

    It would be important that people understand this risk and a great way to do that is to make sure there’s labeling on those types of medications. Patients can then be aware and informed that the medications make them feel better but do not change their disease or their risk at all.

    • Mark D. Noar, MD
    • GI Microsurgery Institute
      Howard County Hospital
      Johns Hopkins Medicine
      Townson, Maryland

    Disclosures: Noar reports consulting, speaking and teaching for Mederi Therapeutics.