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Drugs that once seemed safe for patients with cancer or osteoporosis have recently been linked to a rare bone disease that has doctors perplexed and patients worried.
Osteonecrosis of the jaw (ONJ) is a serious, sometimes disfiguring, condition that causes bone tissue to decay and appeared in a number of patients who have received therapies for various bone diseases.
Dr. Robert E. Marx, chief of oral and maxillofacial surgery at the University of Miami, discovered the potential link in 2003 after noticing the condition in 36 patients who had undergone bisphosphonate therapy.
“The common denominator was that they all had cancer. Then we started looking at their treatment. The one common thread was bisphosphonates,” he said.
Bisphosphonates are a class of drugs used to treat debilitating bone diseases such as osteoporosis and Paget''s disease. Doctors have also found the drugs useful for treatment in cancer patients whose disease has spread to their bones.
The drugs, which can be taken orally or intravenously, include Merck''s Fosamax , Novartis''s Zometa and Aredia, and others.
The risk for developing ONJ seems to increase in patients who are taking these drugs and then undergo an invasive dental procedure such as tooth extraction.
The Food and Drug Administration has required the makers of these drugs to disclose the heightened risk for ONJ on a warning label. Despite the risks, however, millions of Americans are dependent on this class of drugs.
According to doctors, bisphosphonates such as Fosamax and others help prevent excruciating bone pain. Patients who rely on the drugs to alleviate their pain are alarmed in light of the recent evidence. Doctors have been besieged by patients wanting more information.
Research efforts are ongoing as the most fundamental questions have yet to be answered. No one knows exactly how great the risk is nor how long the risk persists after bisphosphonate treatment is stopped.
What doctors do know thus far, however, is that the onset of ONJ seems to be triggered by invasive dental procedures.
An article published in The Annals of Internal Medicine recently reviewed a number of reports on ONJ, including one conducted by Dr. Salvatore Ruggerio of Long Island Jewish Hospital.
The collective evidence revealed a 6 to 10 percent increased risk in patients taking the drug intravenously, usually cancer patients. Dr. Ruggerio''s report showed that those taking bisphosphonates orally also faced an increased risk.
Doctors believe that the risk for developing ONJ increases with dosage. However, data is still needed to determine the precise risk.
Dr. Catherine H. Van Poznak at the University of Michigan said that trying to obtain data to identify the risks is frustrating, especially since not all cases are published or reported.
“We''ve seen about 20 patients at Columbia. But it''s so impossible to get a handle on what the incidence is. You just don''t know,” said Dr. Regina Landesberg, a maxillofacial surgeon.
The one question that seems to hang over the entire medical community is should patients stop taking the drugs?
“The pharmaceutical industry has every desire that a patient who starts on a bisphosphonate would take it for life,” said Dr. Robert Gagel of the M.D. Anderson Cancer Center in Houston. “The bone community, of which I am a member, has always been a bit suspicious of that.”
Lawsuits have already been filed against a number of pharmaceutical companies that manufacturer these drugs. Merck, the maker of Fosamax, said that 15 lawsuits have been filed against it. And two suits have been filed against Proctor & Gamble, the maker of Actonel and Didronel.
If you have developed ONJ as a result of taking Fosamax or other bisphosphonate drug, contact us to speak with an experience attorney who can help you understand your rights .
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