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Tuesday February 9, 2010

Dangerous DrugsFor the consumer

First Fosamax Injury Trial Heads to Trial Today in NYC

Trial begins today in the case of a Florida woman who claims taking the osteoporosis drug Fosamax caused her to suffer severe dental and jaw problems.

Shirley Boles, 71, of Walton Beach, Fla., is the first of more than 1,000 former Fosamax users who have sued the drug’s maker, Merck, claiming injuries from the former blockbuster drug. About 1,280 plaintiff groups comprising nearly 900 cases have been filed against Merck relating to injuries allegedly caused by Fosamax, according to a Reuters Health report.

The trial on Boles’ suit is being heard before U.S. District Judge John Keenan of Manhattan Federal Court in New York City. Two other Fosamax lawsuits are also expected to go to trial later this year in federal court and Alabama state court, officials said.

Fosamax, approved by the Food and Drug in 1995, is a bisphosphonate drug similar to Actonel and Boniva. The class of drugs is designed to prevent broken bones in postmenopausal women by increasing bone mineral density.

However, reports of jaw and dental problems in users of Fosamax and other bisphosphonates started surfacing in about 2003.

Boles states in her lawsuit that she took Fosamax from 1997 to 2006 and developed problems with her teeth and jaw. Many people complained of jaw osteonecrosis, a condition involving the death of jawbone tissue that causes pain, swelling or infection of the gums and jaw, gums that don’t heal, and loose teeth.

For its part, Merck says other medical problems Boles had, not her use of Fosamax, caused her to develop jaw and dental complications.

Earlier this year, a study found that the use of Fosamax was linked to an increase in rates of esophageal cancer.

Intravenous and Pill Forms Linked to Problems

Bisphosphonates are administered either intravenously to treat cancer patients or given in pills to osteoporosis sufferers. In May 2005, the pill form was found to be responsible for causing jaw osteonecrosis in seven out of 63 bisphosphonate users in a study.

But a later review of the issue that appeared in the Journal of the American Dental Association last year reached a different conclusion than the 2005 study. The review concluded that oral treatments of Fosamax in fact reduced the risks of inflammatory deterioration associated with jaw in osteoporosis patients and that intravenous delivery of bisphosphonates increased the risks by 400 percent.

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