Will Side Effect Reports Scare Fosamax Patients?
Jan. 1, 2009— -- The end of 2008 was not kind to the osteoporosis drug Fosamax.
The first blow to the medication came Wednesday evening, with the release of a letter in the New England Journal of Medicine, citing a finding by the U.S. Food and Drug Administration that 23 cases of esophageal cancer, possibly linked to the use of the drug, have been seen since Fosamax's 1995 market debut.
The second came just seven hours later with the release of a study in the Journal of the American Dental Association suggesting that a condition known as osteonecrosis of the jaw -- in which the bone in the jaw dies off -- may be more common than thought in people taking osteoporosis drugs in the same class as Fosamax.
Now, as drugmaker Merck & Co. defends its product against this one-two punch, the effect on Fosamax's reputation remains to be seen.
"I couldn't possibly speculate on how these two publications will affect public opinion [on Fosamax]," Merck spokesman Ronald Rogers told ABCNews.com. "What I would hope is that if the public has concerns, they speak with their physician."
Some doctors already speculate that the new report, out of the University of Southern California School of Dentistry in Los Angeles, may affect public acceptance of the drug.
"The link between osteonecrosis of the jaw and bisphosphonates -- especially Fosamax -- has already had some negative impact," said Dr. Donna Shoupe, a professor of obstetrics and gynecology at the Keck School of Medicine at USC who has experience treating women with osteoporosis. "I think this new publication, especially if the media reports it on the national news programs, may again have significant impact."
And it's a situation that has some physicians worried that patients who truly benefit from the drug may be getting the wrong idea about the drug's risks.
"For elderly women with fractures on these drugs, benefits likely still outweigh any theoretic risks," said ABC News contributor Dr. Marie Savard.
Still, she added, "The jawbone damage is troubling to me, since we may just be seeing the tip of the iceberg. After all, the drugs do change bone structure and growth."
