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Drugs for Osteoporosis and Cancer Linked to Osteonecrosis

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Drugs for Osteoporosis and Cancer

Drugs for Osteoporosis and Cancer Linked to Osteonecrosis

November 02, 2006
By: Jean Johnson for Dental1

Osteonecrosis of the jaw bone is not a pretty picture. The teeth are long gone, and what’s left is exposed bone, darkened and rotted. While this problem used to occur only occasionally in cancer patients taking a specific class of drugs called bisphosphonates, it is becoming more common because women of all ages are taking bisphosphonate drugs for osteoporosis.
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Commonly prescribed bisphosphonates include:
  • Zometa
  • Aredia
  • Fosamax
  • Boniva
  • Actonel
  • Skelid
  • Bonefos
  • Didronal
  • Ostec

    Symptoms of osteonecrosis of the jaw are:
  • Pain, swelling, or infection of the gums or jaw
  • Gums that are not healing
  • Dramatic loss of gum tissue
  • Loose teeth
  • Numbness or a feeling of heaviness in the jaw
  • Drainage and exposed bone

  • It has been three years since Robert Marx, DDS, chief of oral and maxillofacial surgery at the University of Miami, published a paper in the Journal of Oral and Maxillofacial Surgery in which he called osteonecrosis of the jaw (ONJ) a “growing epidemic.”

    Marx stated that “painful bone exposure… unresponsive to surgical or medical treatments” was the fate that befell 36 cancer patients who had received intravenous bisphosphonates, drugs used not only for treating cancer, but also for osteoporosis.

    After 63 patients failed to heal normally after oral surgery and instead developed exposed, necrotic jaw bones, Salvatore Ruggiero, M.D., chief of oral and maxillofacial surgery at Long Island Jewish Medical Center, wrote another article on ONJ for the Journal of Oral and Maxillofacial Surgery in 2005.

    “We never saw this before in the jaw,” Ruggiero told USA Today. “It just never existed.”

    More Might Not Be Better

    Bisphosphonates make up the class of osteoporosis and cancer drugs that includes the popular Fosamax. As Marx observed, these drugs have been implicated in the extremely painful, disfiguring, and devastating jaw bone disease ONJ.

    Formerly, bisphosphonates were reserved for use in cancer patients and older women with osteoporosis. Because this group had most of their dental work behind them, they tended not to suffer the adverse consequences of younger patients.

    In response to widespread marketing campaigns, women in their 40s and 50s who are at risk for osteoporosis are asking for Fosamax, and others drugs like it, with greater frequency.

    The problems begin when patients taking these drugs, or who have taken them within 10 years, go to their dentists for a tooth extraction, root canal, or some other type of mouth surgery. Instead of normal healing, painful, disfiguring bone exposure can take place. As John Mathews, DDS, vice president of the Australian Dental Association told OpEdNews.com, “Normally you would treat a condition like this by performing surgery to remove the dead bone.” The problem is, as Mathews explained, that the bisphosphonate deposits throughout the bone, so that removal of the darkened, dead bone simply exposes more of the jaw to infection and there is further bone loss. In extreme cases, patients have had to take nourishment through a feeding tube because their oral cavity is compromised from ONJ.

    American Association of Oral and Maxillofacial Surgeons Take “Urgent” Request to Congress

    Clearly there is a reason the American Association of Oral and Maxillofacial Surgeons (AAOMS) placed research on bisphosphonate-related osteonecrosis of the jaw at the top of its list for 2007 funding from the House Subcommittee on Labor, Health and Human Services, Education and Related Agencies.

    According to written testimony by AAOMS President, Jay P. Malmquist, DMD, “Bisphosphonates, a primary treatment modality for certain types of cancer and for osteoporosis, may lead to a condition known as osteonecrosis of the jaws (ONJ), which can leave patients with large areas of exposed bone in their jaws.

    “The condition is extremely painful, infected, and difficult to treat. At present, an estimated 10 million people in the U.S. have osteoporosis, and their numbers are expected to increase as the population ages.

    “Research is urgently needed to establish the incidence of ONJ in patients being treated with bisphosphonates. We must understand the mechanism of the disease in order to identify risk factors for ONJ and to develop effective treatments.”

    Response from U.S. Food and Drug Administration (FDA) and the Drug Industry

    After the AAOMS brought the matter to the attention of the FDA in December 2005, the federal agency recommended that alerts to the medical community be heightened.

    “Alerts should include as much information as possible (e.g., available data or studies) that demonstrate the risk associated with using a drug or device. This information will allow providers to make informed decisions about using these drugs or devices.”

    Merck and Company – the manufacturer of the popular Fosamax – stated that it has as much as 10 years of data on controlled clinical trials involving more than 17,000 patients. The information indicates that ONJ problems are quite rare and often due to extenuating circumstances including poor oral hygiene and preexisting dental disease.

    Nonetheless, after receiving a request from the FDA in January 2005, Merck updated its labeling with cautionary statements designed to alert physicians, pharmacists, and patients to recent heightened concerns about ONJ and potential complications from Fosamax.

    Academy of General Dentistry Speaks Out with “Strong Recommendation”

    The Academy of General Dentistry (AGD) recognizes the problem as well and explains that bisphosphonates “can bond to bone surfaces and prevent osteoclasts (cells that break down bone) from doing their job.” In May 2006, the AGD also published at article on ONJ and bisphosphonates in its clinical, peer-reviewed journal, General Dentistry.

    “Healthy bones constantly rebuild themselves,” co-author of the report, Sally Jo Placa, DMD, MPA, said. “However, since the jawbones have rapid turnover, they can fail to heal properly in patients taking any of the bisphosphonate drugs. Patients need to be aware of the possibility of complications from dental surgery or extractions.”

    Placa and her co-authors Wellington S. Tsai, DMD, and Kayvon Haghighi, DDS, M.D., cited the case of a woman who received bisphosphonate therapy intravenously to treat metastatic breast cancer. Subsequently the patient had to have teeth extracted by her dentist and in the aftermath developed osteonecrosis in both her upper and lower jaws.

    “It is strongly recommended that patients scheduled to receive bisphosphonate therapy visit a dentist or an oral surgeon so problematic teeth can be treated prior to the start of therapy,” the authors wrote in the AGD article.

    Tsai added that “this type of osteonecrosis has been occurring since the advent of these drugs. At this time, osteonecrosis as a result of bisphosphonate therapy has no treatment.”

    Haghighi underscored that “by informing your dentist that you are taking a bisphosphonate, different avenues for treatment can be explored.”

    In Conclusion

    Placa pointed to the problem of increasing use of bisphosphonates in younger women at risk for osteoporosis. “Widespread use of bisphosphonates to prevent or treat early osteoporosis in relatively young women, and the likelihood of long-term use, is cause for concern,” Placa said. “How bisphosphonates interfere with healing after dental surgery is still unclear and further research will be needed.”

    Placa avoids sensational statements and speaks sensibly about the issue. Still, evidencing profound concern about trends that are under way, she adds a final caveat:

    “It is imperative that the public understands there is no present treatment or cure for this problem.”

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