Boniva is in a class of drugs called bisphosphonates and is commonly marketed to
help and prevent or treat bone loss in osteoporosis.
Bisphosphonates are commonly used in table form to prevent and treat
osteoporosis in post-menopausal women. Stronger forms of bisphosphonates are
commonly 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 cancer,
breast cancer, prostate cancer, multiple myeloma, and others. When
bisphosphonates are given in cancer chemotherapy, the drugs are given
intravenously and usually for longer periods of time.
In December of 2001, Roche and GlaxoSmithKline announced they would co-develop
and promote Boniva for the treatment and prevention of post-menopausal
osteoporosis. In May of 2003, the oral form of Boniva was approved by the FDA
for use once daily. In May of 2004, a supplemental NDA was filed with the FDA
for a once-monthly oral form of Boniva. In December of 2004, Roche and
GlaxoSmithKline announced submission for a new drug, a intravenous injection of
its bisphosphonate, Boniva, for treatment of post-menopausal osteoporosis.
There are over 36 million women who use medications like Boniva to prevent or
slow osteoporosis. Unfortunately, with women taking these drugs at an earlier
age and for much longer time spans, they are at an increased risk of developing
Osteonecrosis of the Jaw (ONJ).
Osteonecrosis of the Jaw (ONJ):
Osteonecrosis of the Jaw (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. Experts say that prevention and early treatment of patients using
bisphosphonates is extremely important in preserving the jawbone.
Death of a Jawbone
Dr. Salvatore Ruggero, in an article published by USA today in March of 2005,
indicated that out of 63 patients he had seen with osteonecrosis or bone death
of the jaw indicated that one patient had taken Actonel, six had taken Fosamax,
and the remaining 56 had been receiving IV bisphosphonates, Zometa or Aredia.
Some doctors have prescribed IV bisphosphonates "off label" for osteoporosis.
Roche and GlaxoSmithKline announced in December they are seeking FDA permission
to market an IV form of their oral bisphosphonate, Boniva, for osteoporosis.
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.
Boniva is in a class of drugs called bisphosphonates and is commonly marketed to
help and prevent or treat bone loss in osteoporosis.