Fosamax Now Linked to Cancer of the Esophagus
The FDA has reported a link between osteoporosis drugs and cancer of the esophagus. The findings are published January 1 in the New England Journal of Medicine.
Eight fatal cases of cancer of the esophagus occurred out of twenty-three reported incidences, associated with Fosamax. In Europe, and Japan six deaths have occurred, linked to Fosamax, out of thirty-one reported incidences. Twenty-one of those deaths are suspected to be related to Fosamax. Actonel, Boniva and Didronel, alone or in combination were linked to six cases, and in four cases, the osteoporosis drugs were used in combination with other drugs..
Diane Wysowski, PhD, from the FDA wrote to the New England Journal of Medicine, pointing out that four patients had a condition known as Barrett's esophagus, which may have contributed to the development of cancer of the esophagus.
Wysowski also writes, "Crystalline material similar to ground alendronate tablets has been found in patients with erosive esophagitis, and persistent mucosal abnormalities have been noted in some of these patients, suggesting a potential for carcinogenic effects," though Merck denies any association between Fosamax and esophageal cancer, citing their database of patients who have taken the drug for long periods.
Wysowski also explains that inflammation of the esophagus, or esophagitis can occur if the osteoporosis drugs are not taken according to directions. Esophagitis is a known precursor to cancer of the esophagus.
The reports to the FDA were received between October1995 and May 2008.
According to Merck, over 150 million prescriptions have been written for Foxamax in the United States alone. The osteoporosis drug has been marketed for thirteen years. Nothing in clinical trials is documented linking Fosamax to esophageal cancer.
N Engl J Med. 2009; 1360:89-90.