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