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Physician-scientist urges improved drug regulation to ensure heart safety of non-heart drugs
Date:12/28/2007

Recommendations by NewYork-Presbyterian/Weill Cornell's Dr. Jeffrey Borer Emphasize Need for Better Attention to Cardiovascular Effects, Beginning With Early Studies and Continuing Past Drug Approval

NEW YORK (Dec. 28, 2007) -- Current regulatory policies should be strengthened to ensure acceptable cardiovascular safety of drugs developed primarily for non-cardiovascular medical problems, according to a recent presentation made by Dr. Jeffrey Borer, an authority in cardiovascular medicine and surgery at NewYork-Presbyterian Hospital/Weill Cornell Medical Center in New York City.

His recommendations include earlier testing of all drugs' cardiovascular effects and giving regulatory bodies the authority to mandate continuing evaluation of drug effects, even after approval for marketing.

"The importance of evaluating the cardiovascular safety of new drugs has been highlighted by recent examples of drugs -- anti-arthritis drugs and others -- that were withdrawn from the market when unacceptable cardiovascular risks were discovered after regulatory approval," says Dr. Borer. "It is clear that drugs intended for non-cardiovascular problems must be more fully scrutinized than in the past in order to allow doctors and patients to be assured that risks are well defined and that they do not outweigh the benefits provided by the drugs for the individual patient. The primary strategy to achieve this goal is increasing formal observations in both pre- and post-approval studies."

Specific recommendations include:

  • Cardiovascular safety assessment should be incorporated in drug development beginning with animal studies of drug effects on cardiac physiology/pharmacology, even if the drug is not intended for cardiovascular problems. Similarly, evaluation of cardiovascular effects should begin in the earliest phases of drug testing in patients. The definitions of adverse cardiovascular events like heart attacks and strokes should
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Contact: Emily Berlanstein
eab2007@med.cornell.edu
212-821-0560
New York- Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell Medical College
Source:Eurekalert

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