IOM: Some drugs need post-approval safety tests

Drugs authorized for sale in spite of bad or risky side effects need safety research after their approval, the Institute of Medicine (IOM) said Tuesday.

The IOM also recommended that the Food and Drug Administration (FDA) make a single, comprehensive record for each drug available to the public that documents safety concerns and regulatory alerts.

It cited the 2004 fiasco over Vioxx, a blockbuster pain reliever that was pulled from the market after it was linked to a concerning rate of heart attacks and strokes.

Two million Americans were taking the medication at the time it was withdrawn, according to USA Today.

A profile for each drug would provide "a more systematic and transparent process" for consumers to obtain information about the risks and benefits of a medication, according to the IOM. 

"Much of this information is already being gathered by FDA, but it is currently scattered across multiple records," a release stated.

"Putting the information into an accessible format in a single document would make FDA's commitment to the life-cycle approach concrete and improve its transparency by giving the public easier access to useful data."

The IOM also recommended that the FDA require additional post-approval research in the case of drugs whose "benefits or risks are particularly uncertain."

It stated that such cases could include " 'first in class' drugs that have been approved based on surrogate endpoints used previously for other drug classes" and those with side effects that pose serious questions about risk.

An example of such a drug would be a blood pressure pill that causes weight gain, the study said.

"We believe that the adoption of a life-cycle approach to drug approval and monitoring will ... increase public confidence in the agency's ability to protect public health," said Steven N. Goodman, a professor of medicine at Stanford University.

Goodman co-chaired the committee that authored the study, which examined "Ethical and Scientific Issues in Studying the Safety of Approved Drugs."

Such additional regulatory actions will "become increasingly important as FDA looks for ways to safely expedite the drug approval process," he said.