Important information about fosamax
Important Information about Fosamax
& Actonel Regarding Jaw Bone Damage
The Food and Drug Administration (FDA) advised dentists and cancer physicians
on May 5, 2005 that the professional product labeling, or package inserts, for the
inject-able 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 Nanover, 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 the treatment of patients with documented bone damage
metastase 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 either of these drugs should avoid invasive dental procedures
during treatment with these drugs. If a patient does develop osteonecrosis of the
jaw, 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 of 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 alendroate
(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 purples. For women at risk of
developing osteoporosis, alendronate and risdronate are also approved to
prevent osteoporosis from developing. The bottom line:
If you take the above-mentioned drugs to prevent osteoporosis, you may
be at risk of losing sections of your jawbone to osteonecrosis.
What you can do:
We know that chlorophyll and vitamin C are important in building bones. Omega
3 fats, raw bone meal supplements, weight bearing exercises and a diet
consisting of live phytonutrients will build strong bone and will also rebuild bone
ends—cartilage, tendons and ligaments.
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