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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
Thank you VICKI BLACKBURN for sharing this information .
What are Biphosphonates?
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 the patient has a normal serum Ca, PTH, Alk. Phos, before starting on this class of medication.
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