Study: U.S. Needs Better Drug Safety Tracking
A new study suggests that the U.S. Food and Drug Administration (FDA) should continually review drugs for as long as they are on the market to identify any new problems with safety.
The Institute of Medicine says that the FDA should craft a document that is available to the public and outlines the risks that emerge throughout the “lifecycle” of a drug. The FDA has been criticized for slowly responding to dangerous side effects that become clearer once the medication hits the market. Such was the case with Vioxx, which was pulled off the market for its link to strokes and heart attacks, according to Reuters.
The agency is only required to check for new safety problems after the drug has been on the market for 18 months or after 10,000 patients have used it. It depends on reports submitted by the drug manufacturer, patients or doctors.
FDA spokeswoman Sandy Walsh says, “We support the general concept of enabling the public to be able to clearly monitor relevant safety issues for all drugs. However, we feel it would be very challenging to implement this recommendation within our current resources without seriously compromising other critical regulatory activities."
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