Petition Filed to Require Warnings of Cancer Risk on Over-the-Counter GERD Drugs

Due to the potential for chronic acid reflux to lead to diseases like esophageal cancer, nonprofit organization Esophageal Cancer Action Network (ECAN) is petitioning the FDA to require new labels on over-the-counter reflux drugs. These labels would particularly spell out the potential link between  esophageal cancer and gastrointestinal reflux disease (GERD).

The proposed language on the label would read:

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.

ECAN’s concern stems from the fact that, with the prevalence of OTC acid reflux drugs like Prilosec and Nexium, individuals now have options to treat GERD without speaking with their doctor. Chronic GERD sufferers may be unaware of the potential for esophageal and throat cancers, for which early intervention is key. A doctor’s assessment necessary to catch cancerous or pre-cancer conditions, such as Barrett’s esophagus.

According to ECAN, though “up to 15 million Americans have daily heartburn,” many Americans are unaware that it can lead to a serious condition. Per the ECAN, only about 1 out of 7 Americans surveyed realized the optential connection between acid reflux esophageal cancer.

ECAN  urges individuals with chronic reflux to speak with their doctors, even when reflux is in remission due to OTC medications. According to ECAN’s press release, esophageal cancer can remain undetected in individuals who are treating it on their own, as opposed to seeking professional treatment.

The risk is that people who are self-medicating may wait until they experience complications from late stage cancer to see a doctor. These complications may include a cancerous tumor int he throat that interferes with swallowing. At that point, the ability to successfully treat the cancer may be severely limited. Indeed, ECAN points to the fact that only “one in five patients [diagnosed with esophageal cancer] survive 5 years after being diagnosed with esophageal cancer

.According to ECAN, mandating the warning label and alerting consumers to the potential cancer risk that GERD may entail will result in saved lives.

Reference: “FDA Petition for Cancer Warnings.”