NEWS - Esophageal cancer in patients on oral bisphosphonates

[Guest guest]

Esophageal Cancer in Patients on Oral Bisphosphonates

December 31, 2008 — 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

alendronate as the suspected drug in 21 cases. Of the remainder, 6

cases were associated with risedronate (Actonel, Procter &

Gamble/Sanofi-Aventis), ibandronate (Boniva, Roche/GlaxoKline),

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;1360:89-90.

http://www.medscape.com/viewarticle/586127

Not an MD

[Guest guest]

My father passed away in 2002 from complications of Non-Barrett's

Esophagael Cancer. Its a nasty, fast moving cancer. He was diagnosed

in November 2001 and was gone by June 2002. While he was not on any

Bisphophonates, my prayer is that pharmaceutical companies continue to

review the potential serious side effects of these drugs so that

people don't suffer unnecessary complications.....Doreen

>

> Esophageal Cancer in Patients on Oral Bisphosphonates

>

>

> December 31, 2008 — 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

> alendronate as the suspected drug in 21 cases. Of the remainder, 6

> cases were associated with risedronate (Actonel, Procter &

> Gamble/Sanofi-Aventis), ibandronate (Boniva, Roche/GlaxoKline),

> 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;1360:89-90.

>

> http://www.medscape.com/viewarticle/586127

>

>

>

> Not an MD

>