Last month we wrote about the mounting problems associated with the popular osteoporosis drug Fosamax. Since that time it has become most apparent that the problems are widespread. As a result, the Fosamax litigation scene will be very active. Osteonecrosis of the jaw (ONJ), a disfiguring condition that leads to the breakdown of the jawbone and loss of teeth, is clearly a most serious matter. Fosamax has been taken by a tremendous number of women for stronger bones. Unfortunately, they were never warned by Merck & Co. of the risks associated with Fosamax. It is now abundantly clear that Merck knew about the risks. The FDA had actually asked the drug company to warn about ONJ. Obviously, Merck had a duty to inform doctors and patients. For years, doctors and dentists have known about the increased risk of ONJ caused by chemotherapy. But, the medical community had little, if any, knowledge connecting Fosamax use and ONJ.
In January 2005, the FDA recommended that Merck change Fosamax’s label to include ONJ warnings. As a result, the company revised its packaging information in July of last year. As we stated last month, this drug is one of Merck’s best sellers, with $3.2 billion in sales and 22.4 million prescriptions written in 2005. The company says on its website that most reported cases of bisphosphonate-associated osteonecrosis have been in cancer patients treated with the drugs intravenously. The statement says:
ONJ is not well understood and may occur for a number of reasons. . . . In controlled clinical trials involving more than 17,000 patients, contributing as much as 10 years’ data with alendronate [the technical name for Fosamax] there have been no reports of ONJ.
At its 2006 annual meeting, the American Association of Endodontists said that until further information becomes available, all patients taking bisphosphonates should be considered at some risk for ONJ. Patients were told to inform their dental care providers and other specialists that they are on the medications. It has been reported that some dentists actually turn away patients who tell them that they are on bisphosphonates. Others ask those patients to quit the medication until their dental treatment is finished.
Perhaps it would be helpful to set out exactly what osteoporosis is all about and how Fosamax comes into the picture. First, let’s take a look at osteoporosis.
• Osteoporosis is thinning and weakening of the bones.
• It affects mostly women after menopause.
• In both men and women, osteoporosis may also be caused by certain medicines called corticosteroids, used to treat some leukemias and also to suppress rejection after bone marrow and organ transplants.
• Osteoporosis can cause fractures, which may happen during everyday activities, such as lifting, or from a minor injury that would normally not cause bones to break.
Fosamax, which is being taken by a tremendous number of women, is made by Merck & Co. As advertised and promoted by Merck, Fosamax is said to be for:
• The treatment or prevention of osteoporosis in women after menopause.
• Treatment to increase bone mass in men with osteoporosis.
• The treatment of osteoporosis in people taking corticosteroids.
Our firm continues to investigate potential claims for women who have taken Fosamax and who have suffered severe injuries and disability as a result. Any person who is now taking Fosamax should contact their personal doctor and discuss whether they should remain on the drug. If you need additional information on the ongoing litigation over the drug, you can either go to our website, BeasleyAllen.com, or contact either Jerry Taylor or Chad Cook directly at our office (800-898-2034).
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