Researchers call for database to track drug safety

A diverse team of physicians and public-health researchers is urging the creation of a national database of widely prescribed drugs to help monitor the risks and benefits of medications. The hope is to prevent a redux of the 2004 Vioxx episode, which saw the hugely popular arthritis medication taken off the market after a study questioned whether the Cox-2 inhibitor didn't raise the risk of heart disease.

Writing in the Archives of Internal Medicine, researchers led by geriatrician Dr. Joseph S. Ross of Mount Sinai School of Medicine in New York, call for an electronic surveillance system to analyze the safety of prescription medications by aggregating data reported from clinical trials. "If we are to detect harms early and protect the public's health, while ensuring the availability of new, clinically effective therapeutics, a system must be established that makes full use of all existing evidence," they write.

"How could we be doing post-market surveillance in a better way?" Ross explains to the New York Times. "For drugs that we are concerned about, that are high risk, this could be a blueprint going forward."

For more information:
- read this New York Times story
- see the complete study in the Archives of Internal Medicine

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