FDA to Study Fosamax Side Effects

Washington, DCThe US Food and Drug Administration (FDA) has announced it is investigating Fosamax side effects and the side effects of other drugs in the same class as Fosamax. Although lawsuits allege patients suffered from Fosamax osteonecrosis of the jaw, the FDA is studying a potential link to cancer. In addition to Fosamax ONJ, some studies suggest a link between use of Fosamax and femur fractures.

Now, the FDA announced it is looking into a potential link between the use of bisphosphonates—a class of drug that includes Fosamax—and the development of throat cancer. The announcement comes after published studies found conflicting results on the issue. The FDA said it will conduct an extensive review into the possibility of a link between esophageal cancer and bisphosphonates.

According to the FDA, two large-scale studies, reviewed by the FDA, obtained opposite results. One study found no increase in the risk of esophageal cancer while a second found double the risk of esophageal cancer in patients who had either 10 or more bisphosphonate prescriptions or had taken the drugs for over three years.

In making its announcement, the FDA said it has not concluded that use of bisphosphonates causes an increased risk of esophageal cancer and currently believes the benefits of oral bisphosphonates outweigh the risks. The agency further noted that esophageal cancer is rare.

The FDA's action will involve reviewing data from published studies to determine whether the use of oral bisphosphonates, including Fosamax, carry an increased risk of cancer of the esophagus.

Patients are advised, however, to discuss the benefits and risks of taking bisphosphonates with their health care professionals and to pay attention to directions so they can minimize the chances of adverse effects. Failure to follow directions can result in an increased risk of inflammation of the esophagus and esophageal bleeding.

Bisphosphonates are used to treat osteoporosis but have been found to cause inflammation of the patient's esophagus, which could potentially increase the risk of throat cancer.

In 2010, the FDA issued a warning that long-term use of bisphosphonates could be linked to an increased risk of fractures of the thighbone. At the time, the FDA announced that the warning label for the drugs would be changed to reflect the possibility that bisphosphonates are linked to a rare but serious fracture of the femur.