[PHNUTR-L] Popular Osteoporosis Drugs Linked to Jaw Bone Damage
Kathrynne Holden, MS, RD
fivestar at nutritionucanlivewith.com
Mon Aug 1 06:27:40 PDT 2005
Colleagues, the following is FYI and does not necessarily reflect my own
opinion. I have no further knowledge of the topic.
Zoledronic Acid (ZOMETA) And Pamidronate (AREDIA) Linked to Jaw Bone
Damage: Popular Osteoporosis Drugs Also Evaluated
Worst Pills Best Pills Newsletter article August, 2005
The Food and Drug Administration (FDA) advised dentists and cancer
physicians on May 5, 2005that the professional product labeling, or
package inserts, for the injectable drugs zoledronic acid (ZOMETA) and
pamidronate (AREDIA) had been revised to warn about the possibility of
osteonecrosis of the jaw with the use of these drugs. Osteonecrosis
literally means “bone death.”
Both zoledronic acid and pamidronate are produced by Novartis
Pharmaceuticals Corporation of East Hanover, NJ.
Zoledronic acid is approved by the FDA to treat high blood levels of
calcium in cancer patients (hypercalcemia of malignancy), the treatment
of patients with multiple myeloma, and patients with documented bone
metastases from their cancers in conjunction with standard cancer
treatment. Pamidronate is approved for the treatment of Paget’s disease,
bone metastases of breast cancer, and multiple myeloma.
Cancer patients receiving treatment with zoledronic acid and pamidronate
have experienced osteonecrosis of the jaw. The revised package inserts
for these drugs now recommend that cancer patients receive a dental
examination prior to beginning treatment with either of these drugs. The
inserts also advise that patients using zoledronic acid or pamidronate
should avoid invasive dental procedures during treatment with these
drugs. If a patient does develop osteonecrosis of the jaw while using
one of these drugs, dental surgery may make the condition worse.
The typical signs and symptoms of osteonecrosis of the jaw include, but
are not limited to: pain, swelling, or infection of the gums; loosening
of the teeth; poor healing of the gums; numbness or a feeling of
heaviness in the jaw; drainage and exposed bone. Patients with the least
serious form of this condition may remain asymptomatic; in the most
serious cases, some may require the removal of sections of the jaw.
Zoledronic acid and pamidronate belong to the family of drugs known as
bisphosphonates. Other members of this family include the oral drugs
alendronate (FOSAMAX) and risedronate (ACTONEL). These two drugs are
approved by the FDA to treat osteoporosis in both men and postmenopausal
women and to treat Paget’s disease. They are also approved to treat
osteoporosis caused by corticosteroids, but should not be used for this
purpose. For women at risk of developing osteoporosis, alendronate and
risedronate are also approved to prevent osteoporosis from developing.
There have also been reports of osteonecrosis of the jaw associated with
the use of oral bisphosphonates in the medical literature. Staff from
the Division of Oral and Maxillofacial Surgery, Long Island Jewish
Medical Center published a report on cases of osteonecrosis observed in
their oral surgery clinic in the May 2004 Journal of Oral and
The researchers reviewed the medical records of all patients who were
seen in their clinic between February 2001 and November 2003 who had
both a diagnosis of jaw infection and a history of chronic
bisphosphonate treatment. They identified 63 cases. Of these 63 cases,
56 had received an injectable bisphosphonate (such as zoledronic acid or
pamidronate) for at least one year. Seven patients had been on chronic
oral bisphosphonate therapy with alendronate and risedronate.
The FDA convened its Oncologic Drugs Advisory Committee on March 4, 2005
to discuss safety concerns specifically associated with the use of
zoledronic acid and pamidronate. They also reviewed the cases repoted in
the study described above, including the cases involving alendronate and
In a memo reviewing all of the cases received by FDA, the agency’s
Office of Drug Safety reported that osteonecrosis of the jaw was related
to alendronate use in 12 cases and to risedronate in one case. The
Office of Drug Safety recommended that the professional product labeling
for alendronate and risedronate also be revised to warn of the
possibility of osteonecrosis of the jaw. At this time, the FDA has not
taken such action.
What You Can Do
You should inform your dentist, in addition to your physician and
pharmacist, about all drugs that you are taking.
Kathrynne Holden, MS, RD < fivestar at nutritionucanlivewith.com >
"Ask the Parkinson Dietitian" http://www.parkinson.org/
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