[PHNUTR-L] Popular Osteoporosis Drugs Linked to Jaw Bone Damage

[Kathrynne Holden, MS, RD]

Colleagues, the following is FYI and does not necessarily reflect my own
opinion. I have no further knowledge of the topic.
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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 
Maxillofacial Surgery.

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 
risedronate.

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.

http://www.worstpills.org/

-- 
Kathrynne Holden, MS, RD < fivestar at nutritionucanlivewith.com >
"Ask the Parkinson Dietitian"  http://www.parkinson.org/
"Eat well, stay well with Parkinson's disease"
"Parkinson's disease: Guidelines for Medical Nutrition Therapy"
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