FDA Reviewing Osteoporosis Drugs for Esophageal Cancer Risk
U.S. regulators are reviewing oral medicines to combat bone weakening from companies such as Merck & Co. and Roche Holding AG (ROG) for evidence they cause esophageal cancer and say patients should still take the drugs.
The Food and Drug Administration made the comments in an announcement today ahead of a meeting of agency advisers Sept. 9, where they will discuss the safety of the osteoporosis treatments. 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.
Merck shares rose 59 cents, or 1.7 percent, to $36.18, at 4:15 p.m. in New York Stock Market trading. Roche shares rose 1.8 Swiss francs, or 1.3 percent, to 141.5 francs at the close of Zurich trading.
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.
Bisphosphonate drugs include Whitehouse Station, New Jersey-based Merck’s Fosamax and Basel, Switzerland-based Roche’s Boniva. The FDA urged those taking the treatment to follow directions carefully, and to take the drug first thing in the morning with a full glass of water.
To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net
To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net.
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