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DrugSafety 4thLd-Writethru 05-22

Feds to study drug use safety

Federal health officials will begin monitoring prescription drug usage by millions of Medicare participants in an effort to identify potential safety problems.

The Food and Drug Administration has been under increasing pressure to develop a comprehensive drug surveillance system since the painkiller Vioxx was pulled from the market in 2004 after it was linked to increased risk of stroke and heart attack.

New regulations announced Thursday by the Health and Human Services Department will enable the FDA, states and academic researchers to screen the Medicare claims data. Under the regulation, the Medicare data can be made available in 30 days.

Medicare beneficiaries use an average of 28 prescriptions a year, and those who consider themselves in poor health have an average of 45 prescriptions annually, giving investigators a huge database of health records to tap into.

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Officials said they no longer would have to wait years to see how a drug or medical device affects millions of people.

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