TERRE HAUTE — Dentists in Terre Haute are among those in the profession who are becoming more concerned about increasing cases of decaying jaw bones apparently linked to osteoporosis drugs such as Fosamax.
The technical name for dying jaw bone is osteonecrosis of the jaw , known as ONJ. Symptoms, which may take weeks or months to appear, include pain, loose teeth, exposed jaw bone in the mouth and drainage, according to the American Dental Association Web site.
The drugs being linked to the condition are known as bisphosphonates. They include Fosamax, Actonel and Boniva, which come in pill form, as well as other bone-strengthening medications given through IVs. The oral drugs are often prescribed for osteoporosis patients. The IV versions are more commonly prescribed for patients dealing with cancers that may attack their bones.
“This is a big topic with us right now,” said Terre Haute dentist Dr. Aaron Luttrell, president of the Western Indiana Dental Society.
The ADA is warning dentists to avoid “invasive dental procedures” in patients on IV bisphosphonates and is recommending a “conservative” approach to dental procedures for any patients using oral bisphosphonates. The organization also recommends anyone planning to begin taking bisphosphonate therapy have any dental procedures done before taking the drugs.
Some cases of ONJ have appeared after someone using bisphosphonates has had a tooth pulled or some other dental procedure, but other cases have appeared “spontaneously,” according to a recent article in Dental Economics.
“We’ve seen about five or six patients” with ONJ, said Dr. Michael Deady, a Terre Haute-based oral surgeon. All his patients were on oral bisphosphonates, mostly Fosamax, he said. Some of the cases appeared linked to previous dental procedures, others appeared “spontaneously,” he said.
“Experimental data is a little bit lacking,” on how exactly bisphosphonates are linked to ONJ, said Dr. Don-John Summerlin, a professor of oral and maxillofacial pathology at the IU Medical Center in Indianapolis. “There’s a lot we don’t know yet,” he said.
One prominent theory, however, holds that because bisphosphonates impede cells in the body that remove old bone tissue while allowing cells that add new bone tissue to continue to function as usual, a patient’s bones “become denser and denser,” Summerlin said.
And while this makes bones tougher to break, it may also make it more difficult for them to heal or naturally rebuild themselves, especially after a dental procedure such as a tooth extraction, according to James H. Foulkes, a Terre Haute dentist and former president of the Academy of General Dentistry.
Why the problem affects jaw bones and not so much other bones may be because of the “unique” quality of that bone, according to Luttrell. The jaw bone breaks down and rebuilds itself more than other bones, he said.
“As far as the dental profession is concerned, there is a definite link [between ONJ and bisphosphonates] and there is no question about that,” Foulkes said. “Our controversy is how to deal with it.”
Lawyers are seizing on the data linking Fosamax – a best selling osteoporosis drug – and other bisphosphonates to ONJ and are advertising to represent ONJ patients who have taken bisphosphonate drugs, whether orally or through an IV. Locally, at least one firm is advertising for such clients.
As of May of this year, Merck and Co. Inc., the pharmaceutical company that makes Fosamax, reported 15 ONJ-related lawsuits had been filed against it, according to CNNMoney.com. In one case, “seven figures” are being sought in damages, CNN reported.
Of the more than 20 million Americans using oral bisphosphonates, the number of reported cases of ONJ seems still to be in the hundreds or few thousands. As of May 2005, just 800 cases had been reported to the FDA, according to Medscape Medical News.
ONJ is “extremely rare,” said Merck spokesman Skip Irvine. “Merck estimates the worldwide cumulative reporting rate … is less than one [case] in 100,000 patient treatment years,” he said.
Merck did a 10-year clinical trial of Fosamax before winning FDA approval in 1995. In that trial, involving 17,000 patients, no cases of ONJ were reported, Irvine said.
But this does not have area dentists sleeping any easier.
“I don’t know how many people really know what’s going on,” Deady said when asked about the low number of reported cases. “If I’ve seen six cases … It’s pretty scary,” he said.
“We’re afraid it may be the tip of the iceberg,” Foulkes said. The fact that the population is aging and more and more people are using bisphosphonates to not only treat but sometimes to try and prevent osteoporosis, means it’s possible more cases may be just over the horizon, he said.
“Intuitively,” IU’s Summerlin said, he believes the risk of ONJ is increasing, but, he adds, he has no data to say that “factually.”
“I would say ‘don’t panic,’” Summerlin said. And, in the case of cancer patients using IV bisphosphonates, he believes the risk of some bone loss is probably greatly outweighed by the benefits of the drugs.
“I don’t think anyone can produce absolute data saying how significant the problem is. I think it is a minority of the patients that have this problem,” but even a small percentage of the millions using bisphosphonates “could be a large number of people,” he said.
For more on ONJ, visit the ADA Web site at www.ada.org.
Arthur Foulkes can be contacted at (812) 231-4232 or arthur.foulkes@tribstar.com.
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Dentists concerned about cases of decaying jaw bones
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