FDA Reviews Esophageal Cancer Risk from Fosamax, Other Bone Drugs

Some oral osteoporosis drugs, known as bisphosponates, may increase the risk of esophageal cancer, according to a statement issued by the FDA. 

In a drug safety communication released Thursday, the federal drug regulators indicated that a review has been launched to examine the potential risk of esophageal cancer from Fosamax, Actonel and similar drugs.

Some data has suggested that use of oral bisphosphonate medications may double the risk of cancer of the esophagus, but the FDA notes that there is conflicting data from other researchers, making it unclear whether the throat cancer concerns are founded.

The drugs under review include Fosamax, Actonel, Boniva, Atelvia, Didronel and Skelid. All are orally taken drugs approved for use as a prevention measure against osteoporosis, which is a weakening of the bones. They are also often used to treat other bone diseases, like Paget’s disease.

Oral bisphosphonates are already known to cause irritation of the esophagus in some patients, which can lead to inflammation or esophageal ulcers, which sometimes bleed.

The study that found an increased throat cancer risk with bisphosphonates was an observational study using data from the U.K. General Practice Research Database. Researchers found that the risk of esophageal cancer doubled in patients who had taken Fosamax or another oral bisphosphonate for longer than three years, or who had been given 10 or more prescriptions of the drugs.

Other studies have found no risk and some findings have even suggested a reduced risk of cancer.

At this time, the FDA has not concluded that oral bisphosphonates increase the risk of esophageal cancer and is recommending that patients carefully follow the drugs’ directions for use and talk to their healthcare professional if they develop difficulty or pain swallowing, chest pain or new and worsening heartburn. All of those symptoms could be signs of a problem with the esophagus.

The review comes just weeks before an FDA advisory committee is scheduled to meet to evaluate the risks associated with long-term use of Fosamax, Actonel, Boniva and Reclast. On September 9, the committee will investigate whether the risk of jaw problems and bone fractures are due to long term use of the drugs and whether there should be a recommended duration for their use. While the committees recommendations are not binding on the FDA, the agency usually follows the guidance of their outside experts.

Long-term use of oral bisphosphonates has been linked to an increased risk of serious and debilitating jaw problems, known as osteonecrosis of the jaw. The condition causes the jaw bone to decay and rot, often resulting in the need for surgery to remove portions of the jaw.

Hundreds of Fosamax lawsuits over jaw problems have been filed against the drug’s maker, Merck. At least one case has resulted in a jury awarding $8 million last year, after finding that Merck failed to adequately research the potential Fosamax side effects or warn about the risk of jaw necrosis.

More recently, use of the medications, particularly Fosamax, has been linked to a growing number of reports involving spontaneous femur fractures, which often occur with little or no trauma at all. A growing number of Fosamax fracture lawsuits are now being filed against Merck, alleging that the drug maker also failed to adequately warn about this risk.