Drug for Bone Disease Linked to 'Jaw Death'
Researchers Report Cases of Osteonecrosis of Jaw in Patients Who Had Teeth Pulled
Dental Extraction and Jaw Death
Drug maker Novartis AG, which markets Aredia and Zometa, also recommends that cancer patients have dental problems corrected before they begin taking either of the drugs. Novartis is a WebMD sponsor.
Yet the researchers also write that a significant number of cases of reported osteonecrosis of the jaw have occurred spontaneously.
In response to an inquiry by WebMD, a company spokeswoman said approximately 1,500 cases of osteonecrosis of the jaw had been reported among patients taking the drugs as of August of this year.
More than 2.8 million cancer patients have been treated with Aredia or Zometa to reduce the risk of cancer-related bone fractures.
In a review of 4,000 patients taking either Aredia or Zometa, 33 patients, or less than 1%, developed the jaw disease.
The study confirmed that having teeth removed put patients at risk for the condition. It was funded by Novartis and conducted by researchers at Houston's University of Texas M.D. Anderson Cancer Center. The findings were reported late last month at the annual meeting of the American Society of Bone and Mineral Research.
"Based on previous findings and the recent M.D. Anderson Cancer Center report, Novartis strongly believes that improving dental care needs to be a priority for cancer patients," states a company news release.
Oral Bisphosphonates and Osteonecrosis
The risks associated with taking bisphosphonates in pill form, like Fosamax, are not well understood.
In a study of 63 patients who developed the jaw condition following oral surgery, about 10% had been taking Fosamax to prevent osteoporosis.
Researchers concluded that bisphosphonates in pill form do not appear to be as likely to cause jaw death as the intravenous versions of the drug. Considering the large number of patients around the world using bisphosphonates for prevention or treatment of osteoporosis, dentists may be dealing with a significant potential complication, they add.
But the FDA has called on the manufacturers of all bisphosphonates to include a warning on their labeling about the risk of osteonecrosis of the jaw, which Fosamax manufacturer Merck did earlier this year. Merck is a WebMD sponsor.
In its label change, the drugmaker noted that it is not clear if patients taking bisphosphonates can lower their risk by stopping treatment prior to having teeth pulled or other dental procedures.
But these medications are metabolized slowly and remain in the bone for many years. It is widely believed that stopping treatment does little good. And once jaw death occurs there is little that can be done to reverse the condition, Hargreaves says.
"The best thing we can do is prevent this from occurring by helping patients reduce their risk," Hargreaves says. "That means saving teeth instead of pulling them."