Merck readies for first Fosamax trial

posted on:
August 12, 2009

author:
Ransdell Pierson

NEW YORK (Reuters) – Merck & Co (MRK.N) on Tuesday is slated to fight the first of numerous U.S. lawsuits brought by patients who claim they suffered jaw damage from the company’s widely used Fosamax treatment for osteoporosis.

Some 1280 plaintiff groups, involving almost 900 cases, have alleged jaw problems due to Fosamax, a one-time blockbuster product that recently began facing generic competition in the United States.

U.S. District Judge John Keenan of Manhattan Federal Court will hear arguments from attorneys for Shirley Boles, a 71-year-old plaintiff from Walton Beach, Florida, who claims to have suffered dental and jaw problems as a consequence of taking Fosamax from 1997 to 2006.

“Unfortunately, Ms. Boles had medical problems that cause people to develop jaw problems, regardless of whether they were taking Fosamax,” Merck said in a statement late Monday.

Fosamax, approved in the United States in 1995, belongs to the bisphosphonate family of osteoporosis drugs that include Procter & Gamble’s (PG.N) Actonel and Roche Holding AG’s (ROG.VX) Boniva. The pills prevent bone fractures — particularly in postmenopausal women — by helping to increase bone mineral density.

In 2003, reports first surfaced linking intravenous bisphosphonate treatments with jaw osteonecrosis, meaning death of jawbone tissue that can include symptoms such as pain, swelling or infection of the gums and jaw, gums that don’t heal, and loose teeth.

Intravenous bisphosphonates, which are not made by Merck, involve higher concentrations of medication that are typically used to treat patients with cancer that has spread to the bones.

Oral versions of the class of drugs were initially thought to be safe until a report came out in May 2005 showing that 7 of 63 bisphosphonate users who developed the condition had been using oral forms.

But an informal review in the Journal of the American Dental Association in early 2008 suggested that oral treatments instead reduced risk of inflammatory deterioration of the jaw in patients with osteoporosis. By contrast, the report suggested a 4-fold increase in such risk among patients taking intravenous bisphosphonates.

Merck said two other Fosamax lawsuits are slated to go to trial later this year, one in federal court and another in a state court in Alabama. The outcomes of those cases, and the Boles case, could give a clearer picture of how well Merck will be able to withstand the hundreds of other lawsuits waiting in the wings.

The drugmaker is better known for controversy over its Vioxx arthritis drug, having withdrawn the blockbuster medicine from the market in 2004 after it was linked to heart attacks.

Merck has resolved claims from most of the thousands of U.S. patients who said they were harmed by Vioxx, with a $4.85 billion settlement.

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