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FDA begins active monitoring of drug safety

BMJ 2008; 336 doi: https://doi.org/10.1136/bmj.a211 (Published 29 May 2008) Cite this as: BMJ 2008;336:1211
  1. Bob Roehr
  1. 1Washington, DC

    After growing fears in recent years over the safety of drugs, the US Food and Drug Administration has announced the start of a surveillance programme to actively monitor drugs for problems.

    The first phase of the Sentinel Initiative will tap into Medicare’s Part D prescription claims database, which serves 25 million Americans aged 65 years or older. Its participants have, on average, 28 prescriptions a year, while those in poor health have about 45. This compares with the US average of about 13 prescriptions a year.

    Under the initiative FDA computers will be able to ask questions of the database and seek out associations between drug …

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