Esophageal Cancer Risk Heightened with Osteoporosis Drugs
-TopNews
01/05/2009- A Food and Drug Administration official said Merck's popular osteoporosis drug Fosamax and other similar bisphosphonates could carry a risk for esophageal cancer and may have been related to at least 50 such cases since 1995.
Diane Wysowski of the Food and Drug Administration's (FDA) division of risk assessment in a letter to the New England Journal of Medicine said researchers should check any possible links between bisphosphonates and esophageal cancer. She said out of the 23 cases reported to the FDA, eight patients died and it typically took two years between the administration of the drug to the development of tumors in the esophagus.
Fosamax, known generically as alendronate has had 21 cases logged in Europe and Japan while Procter & Gamble's Actonel or risedronate and Didronel or etidronate, and Roche's Boniva (ibandronate) have been said to have been involved in six other cases. Six people have died as a result.
Esophagitis, an inflammation of the esophagus, is a known side effect of bisphosphonates and doctors have been warned about prescribing them to patients with Barrett's esophagus which in itself increases risk of esophageal cancer.
Bisphosphonates were given a clean chit by the FDA in November when they said that clinical trial data showed no overall risk of heart rhythm problems in patients taking these drugs.