Biphosphonates are they good for you?
2012
2011
2010
2009
Stontium
Biphosphonates 9/21
Hair loss after weight loss surgery! 5/18
Drug interactions with herbal remedies 5/4
Exercise habit
Pregnancy after duodenal switch 4/27
Calorie calculation 4/13
Cells found in bones 3/11
Calorie predictive relations in energy regulation by rats3/9
2/2
Am I going Bald
Trans Fatty Acids 1/7
2008
Olive oil 12/30
Bariatric surgery before pregnancy 12/5
Antioxidant effects of almonds 10/20
Moderate Exercise Yields Big Benefits 6/1
Cases of esophageal cancer
in patients who had been
taking oral bisphosphonate
drugs for osteoporosis have
been reported by an official
from the Food and Drug
Administration (FDA) in the January 1 issue of the New
England Journal of
Medicine.
Twenty-three cases (of
which 8 were fatal) have
been reported in the United
States, all of them in
association with alendronate
(Fosamax, Merck), which
was cited as the suspect
drug in 21 cases and as a
concomitant drug in 2 cases.
These reports were received
by the FDA in the 12-year
period between October
1995 (when alendronate was
launched in the United
States) and mid-May 2008.
No reports were received
about esophageal cancer and
any of the other oral
bisphosphonate products.
A further 31 cases (6 fatal) have reported in Europe and Japan, with lendronate as the suspected drug in 21 cases. Of the remainder, 6 cases were associated with risedronate (Actonel, Procter & Gamble/Sanofi- Aventis), ibandronate (Boniva, Roche/ GlaxoSmithKli ne), etidronate (Didronel, Procter & Gamble), or a combination of these, and 4 cases cited bisphosphonates as concomitant drugs.
Writing in a letter to the journal, Diane Wysowski, PhD, from the FDA, gives few further details but points out that 4 of the patients had Barrett's esophagus, which is a precursor of esophageal adenocarcinoma. "Physicians should avoid prescribing oral bisphosphonates to patients with Barrett's esophagus," she writes.
Dr. Wysowski also points
out that esophagitis has been
associated with oral
bisphosphonates, usually
when the drugs are not
taken according to
directions. "Crystalline
material similar to ground
alendronate tablets has been
found in patients with
erosive esophagitis, and
persistent mucosal
abnormalities have been
noted in some of these
patients, suggesting a potential for carcinogenic effects," she
writes.
Merck said in a statement that data from
its clinical trials and postmarketing reports
do not suggest any association between
alendronate and esophageal cancer. The
company pointed out that alendronate has
been marketed for 13 years, during which
time more than 150 million prescriptions
have been written in the United States
alone. Merck also noted that its clinical
database includes more than 17,000
patients, of whom about 3000 osteoporosis
patients took alendronate for 3 to 5 years
and about 800 patients took alendronate for
8 to 10 years.
N Engl J Med. 2009;1360:89
These drugs are usually prescribed to prevent or treat Osteoperosis, and also to long time steroid users (cancer patients) to prevent bone loss. It is also prescribed to patients suffering from Paget's Disease. Bisphosphonates are antiresorptive medications, which means they slow or stop the natural process that dissolves bone tissue. Fosamax, a member of this particular group of medications, has recently been linked to a condition called Osteocrenosis of the Jaw (ONJ). Individuals taking Bisphosphonates are also advised to avoid any unnecessary unvasive dental procedures (cleanings are OK).
Biphosphonates have been advocated
strongly for treatment or prevention of
osteoporosis. It has become evident that
there are significant risk associated with
this class of medication.
We strongly suggest that patients discuss these with the prescribing physician before taking this class of medication. When it comes to weight loss surgery and Biphosphonates, it is imperative that ha patient has a normal serum Ca, PTH, Alk. Phos, before starting on this class of medication.