Actonel
(generic name risedronate), manufactured by Procter & Gamble, was granted FDA
approval on March 27, 1998. Actonel is prescribed to treat postmenopausal
osteoporosis. Actonel is a type of drug known as bisphosphonates, the same
family of drugs as Fosamax, Aredia, Zometa and Boniva. Individuals using Actonel
or other bisphosphonates should avoid tooth extractions and other major dental
work while on the drugs.
A connection between Actonel (and other bisphosphonates) and a serious bone
disease called Osteonecrosis of the Jaw (ONJ) was found. Osteonecrosis of the
Jaw (ONJ) is also known as Dead Jaw. This finding was published in the Journal
of Oral and Maxillofacial Surgeons, and it prompted the US Food and Drug
Administration (FDA) and the manufacturer of Actonel to issue a warning to
health care professionals on September 24, 2004.
Bisphosphonates are commonly used in tablet form to prevent and treat
osteporosis in post-menopausal women. Strongers forms if 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.
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, such as Actonel, is extremely important in preserving the
jawbone.
Death of a Jawbone
Dr. Salvatore Ruggiero, 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, 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.
Actonel
(generic name risedronate), manufactured by Procter & Gamble, was granted FDA
approval on March 27, 1998. Actonel is prescribed to treat postmenopausal
osteoporosis. Actonel is a type of drug known as bisphosphonates, the same
family of drugs as Fosamax, Aredia, Zometa and Boniva. Individuals using Actonel
or other bisphosphonates should avoid tooth extractions and other major dental
work while on the drugs.