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Published on 16 June 2010

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FDA to publish drug safety reviews

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Health regulators in the US are to start putting safety reviews online in a bid to keep doctors and patients up-to-date about risks associated with the latest drugs.

The Food and Drug Administration (FDA), which examines the safety of prescription drugs before they become available for sale, is to publish summaries of potential safety issues on recently-approved medicines. The policy has been introduced as some side effects of new products are only known after millions of patients have taken them, which can give rise to safety problems not spotted in the original research.

Dr Robert Boucher, director of the FDA’s office of drug surveillance, said: “That changes the whole game because you don’t know if the drug is effective in that population.”

The FDA usually only sends safety updates in the face of a serious medical issue.

As well as the subsequent side effects reported by doctors, hospitals and patients, the summary will also include the FDA’s own original findings on a drug. The group has previously released little information despite having decades of research in its archives.

Each new drug will receive a summary, as well as those which date back to September 2007, within two years of approval, FDA officials said. The agency plans to publish the summaries on a quarterly basis.

Copyright Press Association 2010
Food and Drug Administration

 



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