Merck - no, not Vioxx! This time it's Fosamax

This growing issue for Merck has been reported on PharmaGossip previously.

Go here for a great primer.

Now the LA Times have got their teeth into it:

"As Merck defends itself against a deluge of litigation involving its pain reliever Vioxx, the pharmaceutical giant also is fielding the first of what could be another wave of lawsuits involving Fosamax, its second-biggest seller.

The emerging litigation targeting the osteoporosis drug, still in its early stages, illustrates how quickly lawyers can organize themselves and assemble prospective plaintiffs after reports of adverse drug effects — even when those problems appear to be relatively rare.

Reports in the last few years have linked Fosamax and similar drugs, known as bisphosphonates, to a serious side effect in which the jawbone partially crumbles and dies. Researchers agree that the incidence of this problem, called osteonecrosis, is quite small.

But trial lawyers are advertising on the Internet and in newspapers for patients who have taken Fosamax or the other drugs, and they are finding potential clients.

"We're getting people calling every day," said Gary Wilson, a lawyer in the Minneapolis office of Robins, Kaplan, Miller & Ciresi.Wilson said his firm had enlisted medical and dental experts to thoroughly review the records of potential plaintiffs who have taken one of the drugs, adding that he would probably file about 20 cases in the coming months.

"It's too early to tell whether these cases will be successful," said Edward Weltman, a San Francisco defense lawyer who represents drug makers. "But as soon as there is publicity about any kind of possible problems with a medication, the plaintiffs get geared up."

Merck spokesman Skip Irvine says that Fosamax is safe and effective in treating osteoporosis and that the company "will vigorously defend ourselves against these suits.""Osteonecrosis is very rare and not well understood," Irvine said, noting that in controlled clinical trials involving more than 17,000 patients, there had been no reports of the malady.

Ethel Siris, a professor of medicine at Columbia University College of Physicians and Surgeons who has also consulted for Merck, said new research studies were underway to understand what triggers the onset of this jaw problem. In the meantime, she said, she tells her osteoporosis patients that the benefits of the bisphosphonate drugs greatly outweigh their risks. Fosamax is probably the best-known brand-name drug for preventing hip fractures and deteriorating bones that often destroy the quality of life for older women.

Millions of women have taken the drug since it was first marketed in 1995.

Fosamax generated $3.2 billion in sales last year, outstripping the other major oral osteoporosis remedies, Actonel, produced by Procter & Gamble Co. and Sanofi-Aventis, and Boniva, made by Roche Laboratories. Scientific reports of jaw problems have generated a wave of newspaper articles that in turn have sown panic among users of the drugs. Many have turned to their doctors or dentists for advice on how to prevent jaw decay and the best treatment options.

Last month, the American Dental Assn. released a set of treatment guidelines. "

And how are a post Vioxx - Merck playing this issue?

One lawyer characterized Merck's posture as "significantly more quiet about the relationship between Fosamax and osteonecrosis of the jaw than they were in disputing the relationship between Vioxx and heart attacks."

"They were very defensive on Vioxx," he said, "and I think they've learned from that and are playing things closer to the chest on Fosamax."

Source: LA Times