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FDA Rallies For Osteoporosis Drug Label Changes


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FDA Rallies For Osteoporosis Drug Label Changes

Acknowledging the potential hazards of using osteoporosis drugs for extended periods, government agencies have announced new label changes for medication.

On Friday, September 9, the U.S. Food and Drug Administration voted 17-6 in favor of clarifying the language on osteoporosis labels, setting upper limits on how long patients should continue using the drugs. The report notes that bisphosphonate treatments can decline in efficiency if overused, which reduces their benefits - especially when compared to potential side effects.

"The panel voted to update the labeling but could not agree on maximum duration of use, noting that there was little data on efficacy and safety beyond the three- to five-year timeframe," Pharma Times reports.

As the news source notes, the new labels could have a severe impact on the bisphosphonates market, as most manufacturers of the drug rely on long-term maintenance dosing for profits.

Still, the FDA is adamant few patients use bisphosphonates for extended periods of time. According to a report from the agency, only 2 percent of patients use the drugs for more than five years.