Shaken by the discovery of serious safety problems with Vioxx and a number of antidepressant drugs approved for marketing in the United States, the FDA announced a series of new steps designed to identify risks associated with prescription medicines currently on the nation's pharmacy shelves.
The measures include a new FDA-sponsored study by the Institute of Medicine to examine the effectiveness of the nation's new drug approval system, and a series of workshops and Advisory Committee meetings that will explore "emerging concerns" about medications already on the market.
The FDA also plans to implement a new program for adjudicating differences of professional opinion concerning possible safety risks posed by approved drugs. Because these scientific "disagreements can have a potentially significant public health impact," the new system will employ an independent "ad hoc panel" of experts to review and resolve disputes, a representative from the agency said.
One study linked multiple pregnancies to an increased risk of developing atrial fibrillation later in life, and another investigated the association between premature delivery and cardiovascular disease.
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