Fosamax
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Fosamax is a drug used for the treatment and
prevention of osteoporosis. It is manufactured by Merck and was
approved by the U.S. Food and Drug Administration (FDA) in 1995.
Fosamax is in a class of drugs known as bisphosphonates. Bisphosphonates
are used to increase bone mass and reduce bone fractures. Typically,
bisphosphonates are prescribed in tablet form such as Fosamax
(generic name – Alendronate Sodium). Intravenous bisphosphonates
such as Zometa and Aredia are used to manage advanced cancers
that have metastasized to the bone, causing bone pain and possibly
fractures.
Bisphosphonates, like Fosamax, have been linked to a serious
bone disease called osteonecrosis, also called “bone death”.
This link was discovered by doctors at Long Island Jewish Medical
Center (LIJ) in New York, in December of 2004 and published in
the Journal of Oral and Maxillofacial Surgeons.
In the study, a review of patient records revealed that all
63 patients diagnosed with osteonecrosis over a three-year period,
had received long-term bisphosphonate therapy. Most of these
(57) were cancer patients who had received the intravenous bisphosphonates
Zomenta and Aredia. About 10% were osteoporosis patients who
had taken an oral bisphosphonate, mainly Fosamax. Doctors reported
that each patient had developed osteonecrosis of the jaw (ONJ)
after normal bone trauma, such as a tooth extraction. The bone
tissue refuses to heal and begins to die. This condition may
result in serious infection and fractures. Most patients require
surgery to remove the diseased bone. The American Association
of Endodontists has released a position statement on the problem. “Until
further information is available, it would appear prudent to
consider ALL patients taking bisphosphonates to be at some risk”
Experts believe that just a fraction of the adverse conditions
linked to bisphosphonates are reported to the FDA. Salvatore
Ruggiero, chief of oral and maxillofacial surgery at LIJ, reports
that as of March 2005 he has seen 13 cases of ONJ in patients
treated with an oral bisphosphonate. Robert Marx, chairman of
the division of oral and maxillofacial surgery at Florida’s
University of Miami reports he is aware of 40 to 50 cases of
ONJ, in the United States, in patients using Fosamax.
The discovery of the connection between osteonecrosis and Fosamax
prompted the U.S. Food and Drug Administration, in March 2005,
to conclude that the labels of all bisphosphonates should include
information about osteonecrosis. Merck has not complied, as of
May 2006.
If you believe that you or a loved one has become ill due to
the use of Fosamax, you need a law firm that is experienced in
handling these cases. If our firm is not qualified to handle
your particular case we will be happy to use our experience and
know-how to help you find a lawyer that can provide you with
the legal representation and dedication you deserve. Remember,
we never charge you any fees or expenses, unless your case is
successful.
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