Dentists and oral surgeons first began noticing the link between jaw bone death and bisphosphonates 5 years ago, and at first thought that it was only the intravenous versions of the drugs administered to cancer patients that posed a risk. But over the past few years, they discovered that oral bisphosphonates also cause ONJ when taken over a long period of time.
In fact, in March 2006, the American Association of Endodontists issued a position statement recommending that oral surgeons check to see if patients are on bisphosphonates and consider those that are to be at risk for ONJ.
Endodontists specialize in root-canal surgery and warn that "until further information becomes available, the AAE recommends that all patients taking bisphosphonates be considered at some risk."
"While bisphosphonates support the buildup of bone in areas weakened by disease," the group says, "as a side effect of treatment, patients may experience the opposite in their lower and upper jawbones."
The debate over ONJ first gained momentum in 2003 when Dr Robert Marx, chief of oral and maxillofacial surgery at the University of Miami, wrote a paper in the Journal of Oral Maxillofacial Surgery and referred to osteonecrosis of the jaw as "a growing epidemic."
Dr Marx reporteded 36 patients who had experienced "painful bone exposure," and "were unresponsive to surgical or medical treatments."
The 36 patients had two things in common. They all had cancer and they were all treated with bisphosphonates.
A little over a year ago, on May 13, 2005, Dr Marx told USA Today that he was aware of at least 40 or 50 cases of ONJ nationwide in patients who had taken Fosamax.
Dr Salvatore Ruggiero, chief of oral surgery at the Long Island Jewish Medical Center in New York, quoted in the Wall Street Journal on April 14, 2006, said that of the 155 ONJ cases he had come across, 22 patients were taking Fosamax or another oral bisphosphonates. Some of these patients took Fosamax for seven or eight years, he said.
"With the oral drugs like Fosamax, exposure time is the key," Dr Ruggiero told the WSJ.
Dr Ruggiero says he first saw patients with breast cancer or multiple myeloma who arrived with exposed bone in their mouths. "It looks like a piece of ivory with little tiny holes in it," said he told Gina Kolata of the New York Times on June 2, 2006.
"The one drug they were all on was bisphosphonates," he added.
Dr Ruggiero said he tried scraping away the dead bone and letting it heal, but that only made things worse. "We were creating a larger bone wound that didn't heal," he said.
He told the Times that he called local cancer specialists, but "they said they did not have any experience with this kind of complication."
Attorneys say Merck is going to have a hard time trying to defend Fosamax cases by saying something else caused ONJ, as it has in Vioxx cases, because so few things cause the disease.
In a nutshell, the lawsuits against Merck allege that the company aggressively marketed Fosamax as safe, despite knowing about the potential and dangerous ONJ, without warning doctors and prospective patients about it.
In fact, in March 2006, the American Association of Endodontists issued a position statement recommending that oral surgeons check to see if patients are on bisphosphonates and consider those that are to be at risk for ONJ.
Endodontists specialize in root-canal surgery and warn that "until further information becomes available, the AAE recommends that all patients taking bisphosphonates be considered at some risk."
"While bisphosphonates support the buildup of bone in areas weakened by disease," the group says, "as a side effect of treatment, patients may experience the opposite in their lower and upper jawbones."
Dr Marx reporteded 36 patients who had experienced "painful bone exposure," and "were unresponsive to surgical or medical treatments."
The 36 patients had two things in common. They all had cancer and they were all treated with bisphosphonates.
A little over a year ago, on May 13, 2005, Dr Marx told USA Today that he was aware of at least 40 or 50 cases of ONJ nationwide in patients who had taken Fosamax.
Dr Salvatore Ruggiero, chief of oral surgery at the Long Island Jewish Medical Center in New York, quoted in the Wall Street Journal on April 14, 2006, said that of the 155 ONJ cases he had come across, 22 patients were taking Fosamax or another oral bisphosphonates. Some of these patients took Fosamax for seven or eight years, he said.
"With the oral drugs like Fosamax, exposure time is the key," Dr Ruggiero told the WSJ.
Dr Ruggiero says he first saw patients with breast cancer or multiple myeloma who arrived with exposed bone in their mouths. "It looks like a piece of ivory with little tiny holes in it," said he told Gina Kolata of the New York Times on June 2, 2006.
"The one drug they were all on was bisphosphonates," he added.
Dr Ruggiero said he tried scraping away the dead bone and letting it heal, but that only made things worse. "We were creating a larger bone wound that didn't heal," he said.
He told the Times that he called local cancer specialists, but "they said they did not have any experience with this kind of complication."
Attorneys say Merck is going to have a hard time trying to defend Fosamax cases by saying something else caused ONJ, as it has in Vioxx cases, because so few things cause the disease.
In a nutshell, the lawsuits against Merck allege that the company aggressively marketed Fosamax as safe, despite knowing about the potential and dangerous ONJ, without warning doctors and prospective patients about it.
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