Oral Osteoporosis Drugs (bisphosphonates): Potential Risk of Esophageal Cancer

The FDA informs Geriatrics, Family Practice and Internal Medicine healthcare professionals that it is evaluating data on oral osteoporosis drugs (bisphosphonates) and the potentially increased risk of esophageal cancer.

Background of Oral Osteoporosis Drugs (bisphosphonates)

Oral Osteoporosis Drugs (bisphosphonates) are used to prevent and treat osteoporosis and to treat bone diseases like Paget’s disease.

FDA Alert on Oral Osteoporosis Drugs (bisphosphonates)

FDA’s reason for the drug safety communication is that there have been conflicting findings from studies evaluating the risk of esophageal cancer from the use of oral bisphosphonates.

Reports of esophagitis and other esophageal events have been recorded and the Agency will continue to evaluate the data.

This safety communication involves the following oral osteoporosis drugs (bisphosphonates):

• Actonel (risedronate),
• Atelvia (risedronate delayed release),
• Boniva (ibandronate),
• Didronel (etidronate),
• Fosamax (alendronate), and
• Skelid (tiludronate)

Recommendation on Oral Osteoporosis Drugs (bisphosphonates)

“Patients should talk with their healthcare professional about the benefits and risks of taking oral bisphosphonates and how long they should expect to take them. Patients should talk with their healthcare professional if they develop swallowing difficulties, chest pain, new or worsening heartburn, or have trouble or pain when swallowing. Patients should be instructed to carefully follow the directions for use of the oral bisphosphonate drug they are prescribed.”

Contacting the FDA to report cases with Oral Osteoporosis Drugs (bisphosphonates)

In case of detection of adverse events or side effects related to the use of Oral Osteoporosis Drugs (bisphosphonates), healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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