Fosamax News

An effective treatment for Osteoporosis, Fosamax and other bisphosphonates are now linked to jaw necrosis and ONJ in those taking cancer medications.

When Fosamax was first introduced 20 years ago by the pharmaceutical company Merck, it was considered to be almost a miracle drug for the treatment of osteoporosis. Osteoporosis is a common condition of post-menopausal women and others who experience a decrease in bone mass and density. It causes bones to become fragile and to fracture easily. Fosamax (generic name is alendronate), is very effective in building up bone mass and preventing further breakdown of the bone. It is now the thirteenth most frequently prescribed drug in the United States with over 22 million prescriptions filled each year.

Fosamax is a type of bisphosphonate that affects the two main cell groups in the bone. These are called osteoblasts, which make bone material, and osteoclasts, which break down the bone. It is believed bisphosphonates shorten the lifespan of the cells that break down bones, while reinforcing the bone-making osteoblasts. While this results in a very positive outcome for preventing common fractures such as in the spine and hip, for some reason it appears to disrupt the delicate balance between osteoclasts and osteoblasts in the jaw. Bisphosphonates can inhibit new vessel formation here that impairs healing.

After an invasive dental procedure such as having a tooth pulled or dental implants an increasing number of people who take Fosamax are experiencing a rare condition known as osteonecrosis of the jaw (ONJ), also known as jaw death. These patients have severe infections with facial numbness, gum swelling, drainage and little or no gum healing, leaving the jaw bone exposed. This is turn can cause tooth loss and other disfigurement. And because Fosamax has a half life of over 10 years, it remains in the body after treatment is stopped and the dental patient is still at increased risk for osteonecrosis.

A similar condition, osteochemonecrosis or "phossy jaw" is also attributed to the taking of bisphosphonates. It is a painful, potentially disfiguring jaw condition and appears to involve a bacterial infection in the jaw rather than a decreased amount of blood flow as in osteonecrosis. The end result of Fosamax necrosis is the same and the pain levels are also relative.

To make matters worse, ONJ and osteochemonecrosis are very resistant to treatment, with some of the few options being long-term antibiotic use or surgical reduction of the jaw bone. But many dentists believe that once jaw death begins there is very little that can be done to reverse it. If additional surgery is attempted to correct the problem, it appears to only make it worse. Antibiotics only treat the secondary infection.

Researchers thus far have been unable to determine why the jawbone and not other bones in the body are affected by bisphosphonates. Some believe that jaws have a greater blood supply than other bones and a faster bone turnover rate. This is related to daily activities such as chewing, and also the presence of teeth. This causes daily bone remodeling around the periodontal ligament and therefore bisphosphonates become highly concentrated in the jaw. It is not clear why some dental patients taking bisphosphonates are affected by ONJ while others are not.

Jaw death resulting from taking bisphosphonates is relatively uncommon, with about 1,500 cases reported since 2003. Most were diagnosed after having teeth pulled. Less invasive dental procedures such as filling cavities and placing crowns do not appear to trigger ONJ.

Professors of Oral and Maxillofacial Surgery at the University of Miami published a research study in 2005 entitled "Bisphosphonate-Induced Exposed Bone (Osteonecrosis/Osteopetrosis) of the Jaws: Risk Factors, Recognition, Prevention and Treatment." Their conclusion was that "pre-therapy dental care can reduce the incidence of bisphosphonate-related jaw bone exposure and non-surgical dental procedures can prevent new cases." But if patients do not know they are at risk, it will not occur to them to have invasive dental procedures done before starting a regimen of Fosamax, and to avoid such procedures after they have started taking it.

The authors of this study are very concerned about the small number of ONJ cases related to alendronate use (such as Fosamax) that have been studied thus far. "Given that it has a half life of more than 10 years, the current widespread use of alendronate to prevent or treat early osteoporosis in relatively young women and the likelihood of long term use as well as the ubiquitous presence of dental disease in our society gives us cause for concern." Shouldn't wealthy pharmaceutical companies such as Merck be funding such research studies or carrying out research of their own?

Merck's own statistics indicate that over 10 million individuals have or are at risk of osteoporosis, with 80% of them women. Almost 34 million more have low bone mass, which puts them at an increased risk of osteoporosis. "Yet only a relatively small number of men and women with osteoporosis have been diagnosed or treated." These numbers also demonstrate the increased potential for jaw death if patients are not warned ahead of time of the risks.

Warnings to Doctors, Dentists, and Patients
A quick look on Fosamax's official Web site, www.fosamax.com, shows no warnings about the potential for jaw death. There are warnings to stop taking Fosamax if you experience symptoms such as heartburn; difficult or painful swallowing; chest pain; bone, joint or muscle pain or if you have a known disorder of the esophagus. No mention of jaw bone decay is made in television or print ads.

A prescription filled in May, 2006 came with a written notice to "check with your doctor as soon as possible if you experience pain or swelling in the gums, loosening of teeth, or numbness or feeling of heaviness in the jaw." This is a lot different than saying "avoid invasive dental surgery while taking Fosamax and for at least 10 years after to reduce the risk of osteonecrosis." By the time pain and swelling are experienced the damage may already have been done.

The main avenue for dentists to hear about the risk of certain dental procedures while taking Fosamax appears to be by presentations heard at conferences or research articles published in journals. Since the FDA issued a warning in 2005, doctors who prescribe Fosamax have been notified, but dentists have not since they don't write the prescriptions.

Dr. Nishan Odabashian, an endodontist in Las Vegas, NV, believes "drug companies like Merck have to do a much better job of alerting the medical community and the public about what their drugs can do when it comes to dental procedures. I have received nothing from them about what bisphosphonates can do and I don't think much of the medical community is aware of this situation." Dr. Ken Hargreaves, a Texas researcher who published a study of bisphosphonates and dentistry in the Journal of Endodontics, reports that "a growing epidemic is underway and the medical community must be proactive." If more dentists and medical doctors were aware of the risks, they could counsel their patients to have a complete dental exam with X-rays before beginning treatment with Fosamax. That way teeth extractions or other major dental work could be taken care of beforehand.

The Federal Food and Drug Administration posted warnings about intravenous bisphosphonates used in cancer treatments in 2004. In 2005 it was expanded to include bisphosphonates such Fosamax that are taken orally. However, the FDA noted that "causality can not be determined" at this time.

Merck has included a possible link to ONJ on Page 13 of a brochure given to medical doctors in July, 2005. "Patients who develop osteonecrosis of the jaw (ONJ) while on bisphosphonates therapy should receive care by an oral surgeon. Dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuance of bisphosphonate treatment reduces the risk for ONJ."

Compare the reaction of Merck to that of Novartis, which markets bisphosphonates called Zometa and Aredia that are taken intravenously by cancer patients. Labeling on these drugs was updated in 2004 to include precautions about ONJ. The warning states that a dental exam and preventative dentistry should be considered prior to treatment with bisphosphonates. The company brought together two advisory boards on the issue, and the boards produced a white paper that Novartis distributed at the American Society of Clinical Oncology's annual meeting in June 2004. They will publish the white paper recommendations for diagnosis, prevention and treatment of ONJ in peer-reviewed oncology and dental journals. Novartis will also undertake a review of cancer patients treated with intravenous bisphosphonates in the last 10 years, which is being conducted at the M.D. Anderson Cancer Center. This effort will ultimately include a review of over 4,000 patients.

Since Merck has known the risk of jaw death as a result of taking Fosamax since 2003 and has failed to provide warnings on the Fosamax label, dental patients with ONJ who have taken Fosamax appear to have a case for a lawsuit. There are numerous law firms that can be found on the Internet who specialize in this area and can help you get the compensation you deserve.