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Doctor Fights for Stronger Drug Labeling

Joe Cantlupe, for HealthLeaders Media, September 15, 2011

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.

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