Over the last several years, there have been concerns that the bone-strengthening drugs used by millions of post-menopausal women could have reverse impacts for some who may take the medication for years. The Food and Drug Administration is considering whether there should be more stringent warnings after reports of inexplicable fractures suffered by users who took the drugs for five years or more.
Jennifer P. Schneider, MD, a 69-year-old physician from Tucson, AZ, says the FDA isn't tough on controlling the drugs, generically known as bisphosphonates. Schneider speaks from experience. A decade ago, as she stood in a New York subway car, Schneider collapsed under a fractured femur. She had been taking Fosamax for seven years. Other bisphosphonates include Actonel and Bonivan.
This month, Schneider attended a hearing of two FDA advisory committees, and testified that she conducted a study of 111 patients and found problems among those who had taken the medication for 5 years or more. Their bones "were as fragile as when China dishes fall," she says. Like her, those patients had taken the drugs for osteopenia, a pre-osteoporosis condition. Now she is leading efforts to improve warnings for people who take bisphosphonates.
The FDA issued advisories last Friday about the medication, but has yet to rule on drug labeling language. Schneider believes the agency should impose tougher restrictions, such as so called "black box" warnings that she says would reduce the number of people taking the medication for several years. The agency states that only about 1% of patients take the drugs for longer than five years.
Black box warnings refer to serious complications related to a drug or life-threatening impacts.
The advisory panels that heard Schneider and others testify agreed that there should be enhanced "cautionary language" on the product, but they didn't say what that language should be, or whether there should be a limit in the length of time the drug is used, according to The New York Times, which estimates that 11 % of women 55 and older take the drugs to prevent bone fractures.
Over the years, the drugs have been shown to slow bone loss, increase bone density and cut fracture rates in women with osteoporosis.
But there have been reports linking the drugs to osteonecrosis of the jaw and the femur fractures. The fractures sometimes occurred in both femurs and recovery period was lengthy, Schneider says. The FDA last year issued a safety announcement requiring warnings to physicians and patients about the potential complications of the drugs. Schneider insists those warnings aren't effective.
"Most doctors won't read a 40-page insert (safety announcement). You need to catch a doctors' attention," Schneider says. "The advisory was a good first step, but I'm hoping for the black box warning." Schneider leads a support group of women, and some men, who suffered similar bone-fracture experiences to hers. "We are constantly educating doctors because it's amazing how many doctors don't see the warnings," and lack of awareness of potential complications, she says.
Schneider, an internist who has specialized in addiction, has spent a career working on pain management issues. Now, as a part-time physician, she has doggedly sought changes in government policy related to the bone issue.
"I think they are totally waffling," Schneider says, referring to the FDA. Interestingly, FDA's staff has suggested that benefits of the drug have not been proven longer than three to five years. The FDA's advisory committees weren't quite so definitive. While the agency often listens to its advisory committees, it doesn't have to, Schneider notes.
Schneider has written extensively on the subject, interviewing other patients who related horror stories like hers. In 2009, she wrote a report in Geriatrics, referring to patients who developed "spontaneous" stress fractures after they had taken the drug for several years.
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.
