Novartis
and FDA notified dental healthcare professionals in a "Dear Doctor" letter of
revisions to the prescribing information to describe the occurrence of
Osteonecrosis of the Jaw (ONJ) observed in cancer patients receiving treatment
with intravenous bisphosphonates, Zometa (generic: zoledronic acid).
The letter also said patients should avoid invasive dental procedures while on
the drug. Novartis first warned of the jaw problem last September and sent a
warning to dentists and doctors.
FDA officials, however, were concerned that many dentists and patients were not
aware of the potential for jaw problems. The issue was discussed at an FDA
advisory panel meeting in March. Novartis said it had started studies to see if
there’s a link between the jaw problems and patients taking Zometa.
As of March, Novartis officials said they had received 875 reports of
osteonecrosis of the jaw from December 2002 through February 2005. Zometa was
first put on the U. S. market in 2001 and had more than $1 billion in global
sales. Zometa is used in the treatment of hypocalcaemia of malignancy, the
treatment of patients with multiple myeloma and patients with documented bone
metastases from solid tumors, in conjunction with standard antineoplastic
therapy.
Osteonecrosis of the Jaw (ONJ):
Osteonecrosis of the jaw (ONJ) has been reported in patients with cancer
receiving treatment regimens including bisphosphonates. Many of these patients
were also receiving chemotherapy and corticosteroids. The majority of reported
cases have been associated with dental procedures such as tooth extraction. Many
had signs of local infection including osteomyelitis.
A dental examination with appropriate preventive dentistry should be considered
prior to treatment with bisphosphonates in patients with concomitant risk
factors (e.g. cancer, chemotherapy, cortisteroids, poor oral hygiene).
ONJ is a complex problem with multiple risk factors. Typical signs and symptoms
of ONJ 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. The seriousness of ONJ ranges
from a patient being asymptomatic to requiring sections of the jaw to be
removed.
Death of a Jawbone
In a recent article published on March 13, 2005, by USA today entitled "Death of
a Jawbone," Dr. Salvatore Ruggiero, Chief of Oral and Maxillofacial Surgery at
Long Island Jewish Medical Center, revealed a common thread with patients
undergoing oral surgery that had failed to heal. The thread was bisphosphonates.
Most were cancer patients who had received the intravenous bisphosphonates,
Aredia or Zometa, or both, for excessive calcium in their blood or bone tumors.
Bisphosphonates remain in bone indefinitely. In the article, Ruggiero speculates
the long-term use of bisphosphonates could upset the delicate balance between
cells that put calcium in bone and cells that take calcium away.
The FDA review concluded that all bisphosphonate labels should mention
osteonecrosis.
Novartis, maker of Aredia and Zometa, added a precaution about ONJ to their
package inserts in August, 2005, although the inserts note that cancer patients
have other osteonecrosis risk factors, such as their malignancies.
Interestingly, some doctors have prescribed IV bisphosphonates "off label" for
osteoporosis. Roche and GlaxoSmithKline announced in December that they are
seeking FDA permission to market an IV form of their oral bisphosphonate, Boniva,
for osteoporosis.
In May of 2004, a New York doctor indicated out of 63 patients with the jaw
condition treated from February 2001 to November 2003, 56 had received the IV
drugs, Aredia or Zometa.
Contact Us
Davis & Feder P.A. is now handling claims for individuals who have been diagnosed
with Osteonecrosis of the Jaw (ONJ). Davis & Feder P.A. is experienced in
pharmaceutical product liability cases and settlements. If you or a loved one
has suffered Osteonecrosis of the Jaw (ONJ), contact us at 1-866-857-8500.
Novartis
and FDA notified dental healthcare professionals in a "Dear Doctor" letter of
revisions to the prescribing information to describe the occurrence of
Osteonecrosis of the Jaw (ONJ) observed in cancer patients receiving treatment
with intravenous bisphosphonates, Zometa (generic: zoledronic acid).