Remember Vioxx, the drug that eased the pain of millions of arthritic Americans—until it was suddenly pulled from the market in 2004, after it was determined that it also caused heart attacks and strokes? Vioxx manufacturer Merck shelled out $4.85 billion in 2007 to settle up with 140,000 Vioxx heart attack victims.
Looks like it might be déjà vu all over again for Merck, as over 600 lawsuits have been filed against the Pharma giant by women alleging that their use of Fosamax caused ONJ (osteonecrosis of the jaw), a painful and potentially debilitating condition characterized by loose teeth, gum infections and, in severe cases, exposure of the jaw bone within the mouth. The first case is due to come to trial next August.
Merck, which posted sales of about $3 billion a year from Fosamax till its patent expiration in February 2008 cut that amount in half, cites studies that show the incidence of ONJ while on Fosamax is negligible: .7 per 100,000, or less than one person in 100,000.
But if the data is true, why are there 600 women claiming Fosamax caused them serious jaw problems? At .7 per 100,000, that would have to work out to over 85 billion Fosamax users. Not.
And last week, the Journal of the American Dental Association featured a study linking Fosamax with ONJ. Lead author Dr. Parish Sedghizadeh, assistant professor of clinical dentistry at the University of Southern California School of Dentistry, said that by searching the school’s medical records database, he and his co-authors found that nine of 208 patients taking Fosamax developed active ONJ after having had a tooth extracted, or suffering trauma in the mouth—about 4%, or about 4,000 per 100,000, far above previous studies’ .7 per 100,000.
In addition, the study offered that of the additional 4,384 patient records examined, all of whom had had a tooth extraction or mouth trauma—but none of whom were on Fosamax—not a single case of ONJ was noted.
Merck took another hit Dec. 31, when a U.S. Food and Drug Administration official said that Fosamax and other bisphosphonates may carry a risk for esophageal cancer. The FDA’s Diane Wysowski, in the Jan. 1 edition of the New England Journal of Medicine, noted that since 1995, 23 patients on Fosamax have developed esophageal tumors; and eight of those patients have died. In Europe, 21 cases of esophageal cancer have been identified, as well as six cases involving other bisphosphonates; six of those patients have died.
Meanwhile, millions of us continue to take Fosamax, the most-prescribed osteoporosis drug, and the 21st most-prescribed American drug overall.
Should we worry about putting ourselves at risk?
Right now, the data, though scary, indicates we should continue to take Fosamax and other bisphosphonates to slow or stop osteoporosis. After all, the risk of fracture if we DON’T take a bisphosphonate is greater than the risk of those drugs’ most dangerous known side effects: ONJ, and cancer.
Or so it appears. At least for now.
Why does Vioxx keep popping into my head?
Published On: January 14, 2009