With hundreds of people across the country charging that an osteoporosis drug led to jawbone ailments, doctors are in a heated debate about how to best treat thinning bones–a common malady of the elderly, particularly women.
In lawsuits across the U.S. nearly 1,400 plaintiffs claim that Fosamax, a drug made by Merck, caused debilitating jawbone deterioration, according to The New York Times.
The litigation sets the stage for a broader issue: Whether women who have not yet developed osteoporosis should take Fosamax and similar bone-strengthening medications known as oral bisphosphonates.
Last month, the Food and Drug Administration issued a warning that bisphosphonates had been linked to certain rare conditions, including thigh fractures. Although the FDA said it was not clear whether the class of drugs causes bone fractures, it said the safety of the medications for long-term use had not been established.
The FDA will now require that labels on Fosamax and similar drugs disclose that the optimal period for using the drugs is unknown.
Yet, for postmenopausal women with osteoporosis, bisphosphonates have been shown to be remarkably successful in reducing fractures. And doctors have often prescribed the drugs to women who have not yet developed osteoporosis but are beginning to show signs of the disease. Now that practice is being questioned.
“We are moving much more to targeting people later in the development of osteoporosis when they are at high risk of fracture, since we’re not entirely clear yet how long is the most appropriate length of time to treat a person,” Dr. Elizabeth Shane told the Times.
In one of several bellwether cases, the lawsuit of Judith Graves, 67, is currently in trial in Manhattan. Her lawsuit claims that Fosamax caused the rare condition known as jawbone death, requiring her to undergo five major surgeries.
Merck argues that Fosamax does not cause the condition. According to The Times, the company won an earlier case, but the jury in another ordered Merck to pay $8 million in damages. A judge proposed to reduce the award to $1.5 million, and both sides plan to appeal.
