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Published on 10 July 2007

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Noncardiac drug risk framework call

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Recommendations for rethinking regulatory policies on the cardiovascular risk of noncardiac drugs have been developed by a group of scientists and regulators, according to an article in the European Heart Journal.

The suggestions were originally developed at a December 2005 meeting of cardiovascular clinical trialists, biostatisticians, FDA and EMEA regulators, representatives of the US National Institutes of Health (NIH), and drug-industry scientists. They outline strategies to enable reasonably certain exclusion of unacceptable risks.

The authors note that several non-cardiac drugs (eg rofecoxib) have recently ceased marketing due to cardiovascular risk. They state: “Pharmacological actions of a single drug can differ among functionally different organ systems; benefit for non-cardiovascular targets may be associated with cardiovascular adversity.

“However, cardiovascular testing is not a major focus of evaluation and development of non-cardiovascular drugs. Consequently, at approval, the relation between non-cardiovascular benefit and cardiovascular risk may not be adequately defined”.

European Heart Journal, published online ahead of print 5/7/2007

 



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