Thursday, July 21, 2011

FDA Reviewing Oral Bisphosphonates for Esophageal Cancer Risk


As if leg fractures were not enough to consider in the September 9 meeting.

U.S. regulators are reviewing oral medicines to combat bone weakening from companies such as Merck & Co., Roche Holding AG (ROG) and Novartis AG (NOVN) for evidence they cause esophageal cancer and say patients should still take the drugs.

The Food and Drug Administration made the comments in a safety announcement today ahead of a meeting of agency advisers Sept. 9, where they will discuss the safety of the treatments for osteoporosis. The agency is reviewing conflicting studies based on U.K. data that found no increased risk and a doubling in the risk of the throat cancer.

More than 40 million people either have osteoporosis in the U.S. or are at high risk because of too low bone mass, according to the National Institutes of Health. The disease is a structural deterioration of tissue that leads to fragile bones and an increased risk for fractures.

“The benefits of oral bisphosphonate drugs in reducing the risk of serious fractures in people with osteoporosis continue to outweigh their potential risks,” the FDA said.

Differences in methodologies may account for discrepancies in findings, the agency said. The gastrointestinal side effects of bisphosphonates could increase a patient’s likelihood of undergoing an endoscopy that would lead to more cancer detection, the agency said.

The September 9 meeting of the FDA should be lively.

I am wondering if these drugs will persist with so many side effects and lawsuits?

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