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Source: North Shore-Long Island Jewish Health System
     Date: 2004-12-30
     URL: http://www.sciencedaily.com/releases/2004/12/041220005619.htm

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Doctors Link Common Chemotherapy Drug To Jawbone Necrosis
NEW HYDE PARK, NY -- Doctors at Long Island Jewish (LIJ) Medical Center
recently discovered a link between a common chemotherapy drug and a serious
bone disease called osteonecrosis of the jaw (ONJ). The discovery, published
in the Journal of Oral and Maxillofacial Surgeons, prompted both the US Food
and Drug Administration (FDA) and Novartis, the manufacturer of
bisphosphonates used in cancer chemotherapy, to issue warnings earlier this
fall to physicians and dentists about the risk for this potential adverse
effect. ONJ is a condition in which the bone tissue in the jaw fails to heal
after minor trauma such as a tooth extraction, causing the bone to be
exposed. The exposure can eventually lead to infection and fracture and may
require long-term antibiotic therapy or surgery to remove the dying bone
tissue.

The chief of the Division of Oral and Maxillofacial Surgery at LIJ,
Salvatore Ruggiero, DMD, MD, and his staff reported that they were struck by
a cluster of cancer patients with necrotic lesions in the jaw -- a condition
they rarely saw, in only about one to two patients a year. When they
launched a study of patients' charts, they found that 63 patients diagnosed
with this condition over a three-year period shared only one common clinical
feature: they had all received long-term bisphosphonate therapy.

Bisphosphonates are commonly used in tablet form to prevent and treat
osteoporosis in post-menopausal women. Stronger forms are widely used in the
management of advanced cancers that have metastasized to the bone, where the
disease often causes bone pain and possibly even fractures. Several cancers
can involve or metastasize to the bone, including lung, breast, prostate,
multiple myeloma and others. In cancer chemotherapy, the drugs are given
intravenously, and usually for long periods of time.

In their study, Dr. Ruggiero and his staff teamed up with Bhoomi Mehrotra,
MD, in the Division of Hematology-Oncology at LIJ, and doctors in the
Oral-Maxillofacial Surgery Division at the University of Maryland Medical
Center. Of the 63 patients diagnosed with ONJ between February 2001 and
November 2003 at their centers, 56 were cancer patients who had received
infusions of bisphosphonates for at least a year and seven were non-cancer
patients who had been receiving long-term oral therapy for osteoporosis. The
patients developed ONJ after normal bone trauma, such as a tooth extraction,
while receiving bisphosphonate therapy. Rather than healing, the bone began
to die, and the majority of patients required surgery to remove the diseased
bone.

In the FDA MedWatch and Novartis alerts issued in late September,
oncologists and dentists were advised of the addition of osteonecrosis of
the jaw to the "Precautions" and "Adverse Reactions" sections on the
labeling of injectable bisphosphonates, describing the spontaneous reports
of the condition being found mostly in cancer patients. The alerts also
recommend a dental examination with appropriate preventive dentistry in
patients with risk factors such as cancer, chemotherapy, corticosteroids and
poor oral hygiene prior to initiating treatment with bisphosphonates.

"Monitoring the dental health of patients on bisphosphonates is key because
an early diagnosis may reduce the complications resulting from advanced
destruction of the jaw bone," said Dr. Ruggiero. "Since our paper was
published and dentists became aware of the connection, many more patients
with the condition have been identified, even in our own center. Prevention
and early detection are so important to preserving the jaw bone in these
individuals." Individuals should attempt to avoid tooth extractions and
other major dental work while on the drugs.

Bisphosphonates block the work of bone cells called osteoclasts, one of two
important types of bone cells that are involved in the continuous process of
bone remodeling in a delicate balancing act. During this process,
osteoblasts -- "the good guys"-- put calcium in the matrix of the bone and
make bone stronger, and osteoclasts -- "the bad guys" -- take calcium away,
diminishing the internal strength of the bone. Bone remodeling is like a
necessary game of tug-of-war between the goods guys and the bad. Bone mass
and mineral content constantly adjust throughout the life cycle to support
the places on the skeleton where the most outside force occurs.

Novartis's Aredia? (pamidronate disodium) and Zometa? (zoledronic acid)
injections are the two intravenous bisphophosphonates used in chemotherapy
regimens. Novartis changed their labeling in August. Merck's Fosamax?
(alendronate) and Procter and Gamble Pharmaceuticals's Actonel? (risedronate
sodium) are the most commonly used oral bisphosphonates, which are only
indicated for osteoporosis. Labeling for the oral forms has not been
changed. "The oral form is much less potent than the intravenous form and
appears to be substantially less likely to cause the problem," said Dr.
Ruggiero.