OSTEOPOROSIS DRUGS AND ESOPHAGUS CANCER
OSTEOPOROSIS DRUGS AND ESOPHAGUS CANCER
OSTEOPOROSIS DRUGS AND ESOPHAGUS CANCER
What is Esophagus Cancer ?
In the study, the researchers reported that the reasons behind the increase in the level of cancer cells are still unknown.
The esophagus is a hollow tube that carries food and liquids from our throat to the stomach. Early esophageal cancer usually does not cause symptoms. However, as the cancer grows, symptoms may include painful or difficult swallowing, weight loss and coughing up blood.
Risk factors for developing esophageal cancer include
1.Smoking
2.Heavy drinking
. 3. Damage from acid reflux.
In Great Britain scientists found by research that esophageal cancer may be more common after all in patients taking oral bisphosphonate drugs, a type of drug used to treat osteoporosis, for long periods.
In an analysis involving some 80,000 patients tracked for more than seven years on average, individuals diagnosed with esophageal cancer were 1.93 times as likely to have received at least 10 prescriptions for oral bisphosphonates compared with controls not having cancer, which is reported Dr. Jane Green of the University of Oxford in England and colleagues online in BMJ.
While previous research has not found such a connection between osteoporosis drugs and cancer, this most recent study tracked patients for long periods of time, suggesting that long-term use of these medications may be linked to cancer development.
Green and colleagues asserted "Our study ... had the potential to include people with longer durations of bisphosphonate use and also had greater statistical power".
An accompanying editorial by Diane Wysowski, an epidemiologist with the U.S. Food and Drug Administration, noted that links between bisphosphonates and esophageal cancer have been proposed for more than 15 years -- though the editorial made clear that this is not necessarily reflective of the agency's position on the matter.
The FDA has collected a total of 68 case reports of esophageal cancer in patients taking bisphosphonates -- half in the United States and the rest in Europe and Japan -- but has not ordered label warnings. Prescribing information for oral bisphosphonates does include information on risks of other esophageal effects, such as, erosions and strictures, and dosing instructions are geared toward speeding the drugs through the esophagus.
The suggestion of a connection between these agents and esophageal cancer has prompted efforts at systematic research, including the new study.
Green and colleagues examined records of 2,954 patients with esophageal cancer, 2,018 patients with stomach cancer, and 10,641 with colon cancer, along with five controls for each of these cases matched for age, sex, observation time prior to diagnosis, and practice location.
About 3.1 percent of the esophageal cancer patients had received at least one bisphosphonate prescription before diagnosis, compared with 2.4 percent of the controls over a similar period.
Rates of bisphosphonate use were similar in the stomach and colon cancer patients relative to controls, the researchers found.
In the esophageal cancer patients, the relationship with bisphosphonate use appeared to strengthen with the number of prescriptions and with the estimated duration of use.
But the researchers stopped short of concluding that bisphosphonate treatment contributes to esophageal cancer, noting that they could not "rule out the possibility that the associations observed reflect other, unknown, factors that are linked to prolonged use of bisphosphonates and that also increase the risk of esophageal cancer."
The researchers' limitations included the lack of data on the extent to which patients used drugs prescribed to them or on prescriptions received before entry into the database.
The recent report, written by U.S. Food and Drug Administration official Diane Wysowski and published in the current New England Journal of Medicine, shows that the FDA received 23 reports of esophageal cancer possibly linked to the drug between its October 1995 debut and May 2008. Of these patients, eight have died so far, according to the report.
This report also said that "no similar U.S. reports for other oral bisphosphonates were retrieved from the FDA's database for adverse-event reporting" - a statement that seems to spare other drugs in the same class, such as Boniva, Actonel or Didronel, from similar condemnation. Wysowski, however, expresses that she remains unconvinced that the rest of this class of drugs is definitely not linked to esophageal cancer.
In one of the case reports, a patient had Barrett's esophagus before taking the drug a condition that is often a precursor to esophageal cancer. On the basis of these reports, Wysowski urges in her report that physicians may "avoid prescribing oral bisphosphonates to patients with Barrett's esophagus," and concludes that "studies should include oral bisphosphonates as possible risk factors for esophageal cancer.
"It is uncertain if the drugs can cause esophageal cancer," Wysowski said. "However, use of oral bisphosphonates has been linked to inflammation of the esophagus, also called esophagitis, primarily in patients who have not used them according to directions."
"This irritation", she says, may set the esophagus up for cancer later on.
Time to Worry for Fosamax Patients?
Some experts believe this report is concerning enough to warrant a change in doctors' habit of prescribing oral bisphosphonates.
Dr.Donna Shoupe, a professor of obstetrics and gynecology at the Keck School of Medicine at USC says that she is very concerned with using bisphosphonates to patients.
However, most experts said that the incidence of esophageal cancer in patients taking ,Fosamax might not be high enough to warrant concern.
There could be some worrying news for the tens of millions of Americans currently taking Fosamax.
A brief report from the FDA says that the osteoporosis drug Fosamax may be linked to 23 cases of esophageal cancer.
J. Edward Puzas, a professor of orthopaedics at the University of Rochester School of Medicine and Dentistry, added that the data on this particular side effect of Fosamax is incomplete.
"It is premature to make any conclusions about this side effect of the drug," Puzas said.
Merck & Co., the maker of Fosamax, also denied the possible link between the drug and esophageal cancer.
"Data from Merck's clinical trials of Fosamax and from post-marketing reports do not suggest any association between [the drug] and esophageal cancer," Merck spokesman Ronald Rogers said.
According to the National Institutes of Health, osteoporosis affects nearly 10 million Americans, with an additional 34 million at risk for developing the disease. About half of all women and a quarter of men older than 50 will break a bone because of osteoporosis.
Although there is currently no cure for the disease, many of those suffering from osteoporosis find relief in the use of oral bisphosphonates such as Fosamax. These drugs are normally one of the first-line treatments for most osteoporosis patients, as they effectively reduce the risk of fracture and increase bone density.
Currently, more 30 million Americans are taking oral bisphosphonates - either for osteoporosis or another condition, such as a certain type of bone cancer. Before Merck's patent on Fosamax expired earlier this year, it was the most popularly prescribed drug in this class.
Some doctors said that they fear this report could cause unwarranted fear among patients who are currently taking this osteoporosis medication.
""I fear patients will conclude that bisphosphonates cause esophageal cancer and there is not enough evidence here to show that," said Dr. Conrad Johnston, a professor in the Department of Medicine at Indiana University.
This is not the first time that a study has dealt a blow to the reputation of Fosamax and other oral bisphosphonates.
A study published in April,2010, in the Archives of Internal Medicine found that patients taking Fosamax had about an 86 percent increased risk for developing an irregular heartbeat. The study received a huge amount of media attention, despite the fact that much larger studies largely exonerated Fosamax with regard to this side effect.
OSTEOPOROSIS DRUGS AND ESOPHAGUS CANCER
By: Alamgir Mohammad
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