Doctor Fights for Stronger Drug Labeling
Schneider pointed to a recent Canadian study published in the Journal of the American Medical Association stating that women who had been on biosphonates for more than five years had shown a risk of the atypical fractures.
The FDA acknowledges the bone-strengthening drugs must be reviewed. The committees noted that hearings were conducted "in light of recent safety events that appear to be potentially associated with long-term use of bisphosphonates." Drug makers say there shouldn't be a limit on the years the drugs are used.
Schneider is a plaintiff in a lawsuit against Merck, the maker of Fosamax. She insists that the suit is not motivating her efforts to change government policy. An estimated 1,000 lawsuits have been filed against Merck.
"These cases take so many years," Schneider says of her lawsuit. "They are being litigated one at a time; it isn't a class action thing. ""There are hundreds of cases and most of them may wind up in a courtroom run by the same judge. The chances of (mine) being litigated and resolved are very remote. I'll be dead before that happens," she aid.
The FDA may consider issuing a new label for the drugs in November. Schneider was disappointed in the advisory committee meetings, but she's ready to speak her mind. "Anytime there is an opportunity to talk to them, and keeping the issue fresh, that is still progress," she said.
Joe Cantlupe is a senior editor with HealthLeaders Media Online.
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