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Old 14th September 2010, 01:50 PM
Pharma Newshound Pharma Newshound is offline
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Default Bone-Loss Drugs Linked to Increased Risk of Thigh Fracture - FDA May Act

Source: Bloomberg.com

[Also see "FDA considers label changes for bisphosphonates" and "What If, God Forbid, Sally Field Broke Her Leg?"]

Bone-Loss Drugs Linked to Thigh Break, Report Says

By Shannon Pettypiece

Sept. 14 (Bloomberg) -- Drugs to prevent bone loss, including Merck & Co.’s Fosamax, Roche Holding AG’s Boniva and Novartis AG’s Reclast, may be linked to an increased risk of fractures to the thigh bone, researchers said.

As many as 94 percent of 310 patients who had an uncommon type of fracture to the thigh bone were also taking one of the bone-loss drugs called bisphosphonates, according a report released today by the Journal of Bone and Mineral Research. Most had taken the medicine for more than five years.

The drugs are used to treat osteoporosis, which leaves bones weak and more likely to break. U.S. regulators should add an update on the potential link to the drugs’ prescribing information and study their long-term safety, the researchers said. Patients shouldn’t stop taking the drugs based on this finding because they prevent hip and spine fractures, which are more common than the thigh break, said the report’s lead author Elizabeth Shane.

“There is no evidence that this is a causal link, but there is an association so we need to have that information available saying there may be an increased risk,” said Shane, a professor of medicine at Columbia University, in a telephone interview. “For patients with osteoporosis who are at high risk of having a fracture, the benefits outweigh the risks.”

Merck shares rose 16 cents to $36.38 at 9:55 a.m. in New York Stock Exchange composite trading. Novartis rose 35 centimes to 55.5 francs in Zurich trading while Roche fell 1.9 francs to 141.7 francs.

Americans spent $2.16 billion on bone-strengthening drugs in the first half of 2010, according to Norwalk, Connecticut- based research firm IMS Health Inc.

$1.1 Billion for Merck

Fosamax, which is available generically, generated $1.1 billion in sales in 2009 for Whitehouse Station, New Jersey- based Merck, while Boniva brought $977 million in sales for Roche, based in Basel, Switzerland. Reclast produced $472 million for Novartis, also based in Basel. Warner Chilcott Plc’s similarly acting drug Actonel had $222 million in sales for the County Louth, Ireland-based company.

The report was conducted by a panel of scientists convened in 2009 by the Washington-based American Society of Bone and Mineral Research, a professional group representing more than 4,000 doctors and scientists.

‘Atypical Fractures’

Researchers looked at 310 cases of “atypical femur fractures,” which account for less than 1 percent of hip and thigh fractures, said the report. Most of the fractures occurred in patients who had been taking the drugs for more than five years. The review included published and unpublished data and interviews with pharmaceutical companies and U.S. regulators.

“In clinical studies involving more than 28,000 patients, Fosamax has not been associated with increased fracture risk at any skeletal site,” said Merck spokesman Ronald Rogers in an e- mail. “Since bisphosphonates were first approved for the treatment of osteoporosis in 1995, millions of people, primarily women, have been treated.”

Merck said that it updated Fosamax’s prescribing information in July 2009 to “ include references to these fractures.”

The U.S. Food and Drug Administration said in March that it hadn’t found a connection between the drugs and the fractures though it would continue to work with the panel of experts. The FDA asked drug manufacturers in June 2008 to submit information about the potential safety hazard. A December 2008 study found that bisphosphonates didn’t increase the risk of fractures.

Cancer Risk

Separate research released Sept. 3 found the drugs may increase the risk of contracting cancer of the esophagus, according to results published in the British Medical Journal. In that report, researchers found that patients who took bisphosphonates for five years or filled at least 10 prescriptions were twice as likely to be diagnosed with cancer as those who didn’t.

A study reported in the Journal of the American Medical Association last month found no connection between the drugs and the malignancies.

To contact the reporter responsible for this story: Shannon Pettypiece at spettypiece@bloomberg.net
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