Fosamax Side Effects May Increase Risk of Esophageal Tumors

According to an official from the FDA, Fosamax side effects may increase the risk of esophageal cancer. A number of cases have been reported involving individuals who developed esophageal tumors since the osteoporosis drug was first approved in 1995, including at least 8 deaths.

In a letter to the editor published in the current issue of the New England Journal of Medicine, the FDA’s Diane Wysowski indicates that at least 23 reports of Fosamax esophageal cancer have been received by the U.S. drug regulatory agency as of mid-May 2008. In addition, another 21 reports of esophageal tumors among users of Fosamax (known generically as alendronate) were filed in Europe and Japan.

Fosamax is a popular oral osteoporosis drug which is part of a class of drugs known as bisphosphonates, which have been used by millions of people to increase bone density and stregthen bones. However, Wysowski suggests that additional research should be done to evaluate the possible risk factors for esophageal cancer as a side effect of Fosamax and other oral bisphosphonates.

Esophageal cancer affects the tube between the throat and the stomach. As the tumors grow, symptoms may include difficulty swallowing, loss of weight and coughing blood.

An inflammation of the lining of the esophageal tube, known as esophagitis, is a known side effect of Fosamax and other oral bisphosphonates, which often occurs when the drugs are not taken according to directions.

“Physicians should avoid prescribing oral bisphosphonates to patients with Barrett’s esophagus,” wrote Wysowski in the letter published January 1, 2009. “Studies should include oral bisphophonates as possible risk factors for esophageal cancer.”

Out of the 23 reports of esophageal tumors among Fosamax users, 78% involved women, and the median age was 74 years old. Only 14 of the reports included dose information, but 8 of the patients had taken 10mg per day, 5 received 70 mg per week and 1 was taking the “once a week” version of the drug.

In a separate report published in the current issue of the Journal of the American Dental Association, Fosamax side effects have been linked to osteonecrosis of the jaw, a serious and potentially disfiguring condition where the jaw bone decays and dies. Merck & Co., the manufacturer of the drug, currently faces over 600 Fosamax lawsuits that have been filed by users who developed the jaw necrosis, alleging that Merck failed to adequately study their drug and warn about the jaw side effects.