The popular osteoporosis drug Fosamax (alendronate sodium, Merck) and other similar drugs may carry a risk for esophageal cancer, a Food and Drug Administration official said last week.
Diane Wysowski of the FDA’s division of drug risk assessment said researchers should check into potential links between so called bisphosphonate drugs and cancer, according to a press release.
In a letter in the New England Journal of Medicine, Wysowski said that since the initial marketing of Fosamax in 1995, the FDA has received 23 reports of patients who developed esophageal tumors after taking the drug. Typically, 2 years lapsed between the time patients started taking the drug and the onset of esophageal cancer. Eight patients died, according to her report.
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In Europe and Japan, physicians logged 21 cases involving esophageal cancer and Fosamax use, with another six instances where Procter & Gamble’s Actonel (risedronate) and Didronel (etidronate) and Roche’s Boniva (ibandronate) may have been involved. Six
of those patients died, according to the release.
Esophagitis — an inflammation of the lining of the esophagus — is one side effect of the drugs, which is why patients are instructed to remain upright for at least 30 minutes after taking them, she said.
In her letter, Wysowski also recommended that doctors should avoid prescribing the drugs to people with Barrett’s esophagus, which is a change in the lining that leads to the stomach. It is often found in people with acid reflux disease and itself increases the risk of cancer, according to the press release.
Also last week, researchers at the University of Southern California School of Dentistry released clinical data linking alendronate sodium to an increased incidence of jaw necrosis. The study is among the first to acknowledge that even short-term use of
common oral osteoporosis drugs may leave the jaw vulnerable to devastating necrosis, according to the report in the Jan. 1 issue of the Journal of the American Dental Association.
