Popular osteoporosis drug from Merck, Fosamax and similar drugs may carry the risk of esophageal cancer, said an official of the Food and Drug Administration.
Diane Wysowski of the Division of Drug Risk Evaluation of the FDA said investigators should examine the possible relationship between drug called bisphophonate and cancer.
In a letter in the New England Journal of Medicine on Thursday, said that since the first marketing Wysowski Fosamax, known generically as alendronate, in 1995, the FDA has received 23 reports which claimed many patients with tumors of the esophagus.
In particular, two years passed between the onset of drug use and the development of esophageal cancer. Eight patients died, said Wysowski.
In Europe and Japan, 21 cases of Fosamax has been filed and six alleged circumstances involving the drug Actonel or risedronate and etidronate or artificial Didronel, Procter & Gamble and Roche's Boniva, or ibandronate buat. Six people died.
"Esophagitis, an inflammation of the tube that carries food to the stomach, known as the effect of the drug, which makes the patient is instructed to stand for half an hour after taking the drug.
In addition, Wysowski said, physicians should avoid prescribing these drugs to people who have "Barrett's esophagus, which is a change in the route leading to the stomach. It is often found in people who suffer from acid reflux disease - defined as chronic symptoms or mucosal membrane damage due to reverse flow abnormalities in the esophagus - and by itself increases the risk of cancer.
In November, the FDA indicates the clinical trial data do not show all the risk of heart problems in patients taking bisphosphonates.
However, the FDA also said the agency knows that there are conflicting results in other studies and is exploring the possibility of conducting further studies to investigate the risk that may exist.
The drug aims to treat osteoporosis, the weakening of the bones, increasing bone mass. As many as 10 million Americans, mostly women, suffer from osteoporosis.
Diane Wysowski of the Division of Drug Risk Evaluation of the FDA said investigators should examine the possible relationship between drug called bisphophonate and cancer.
In a letter in the New England Journal of Medicine on Thursday, said that since the first marketing Wysowski Fosamax, known generically as alendronate, in 1995, the FDA has received 23 reports which claimed many patients with tumors of the esophagus.
In particular, two years passed between the onset of drug use and the development of esophageal cancer. Eight patients died, said Wysowski.
In Europe and Japan, 21 cases of Fosamax has been filed and six alleged circumstances involving the drug Actonel or risedronate and etidronate or artificial Didronel, Procter & Gamble and Roche's Boniva, or ibandronate buat. Six people died.
"Esophagitis, an inflammation of the tube that carries food to the stomach, known as the effect of the drug, which makes the patient is instructed to stand for half an hour after taking the drug.
In addition, Wysowski said, physicians should avoid prescribing these drugs to people who have "Barrett's esophagus, which is a change in the route leading to the stomach. It is often found in people who suffer from acid reflux disease - defined as chronic symptoms or mucosal membrane damage due to reverse flow abnormalities in the esophagus - and by itself increases the risk of cancer.
In November, the FDA indicates the clinical trial data do not show all the risk of heart problems in patients taking bisphosphonates.
However, the FDA also said the agency knows that there are conflicting results in other studies and is exploring the possibility of conducting further studies to investigate the risk that may exist.
The drug aims to treat osteoporosis, the weakening of the bones, increasing bone mass. As many as 10 million Americans, mostly women, suffer from osteoporosis.
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