US FDA Says That Prescription Painkillers Must Include Warnings About Health Risks

A major category of prescription painkillers will now come with a “black box warning” that alerts consumers to the possible adverse health consequences that come with use of the drugs.

The warnings are being issued by the U.S. Food and Drug Administration (FDA), which is taking drastic measures in response to a frightening rise in prescription drug abuse and prescription drug overdose deaths. Since 1999, the total number of prescription drug OD deaths has quadrupled, resulting in more annual deaths than car accident fatalities, according to the Centers for Disease Control and Prevention (CDC). This alarming trend coincides with a massive rise in the number of prescriptions that have been issued for painkillers and opioids.

Now the federal government is taking action to try to ensure that people are at least aware of the possible risks of using prescription painkillers. A black box warning like the one attached to labels of immediate release opioids is considered the absolutely strongest warning that can be issued by the FDA.

The intent behind the FDA’s issuance of a black box warning is to make sure that doctors are aware of the potential health risks and other dangers posed by certain medications before they prescribe the drugs to patients. In addition to making sure that doctors know about the possible negative health consequences of certain painkillers, the now-mandatory black box warning will also require pharmacists to carry a medication guide for instant-release opioids. The FDA encourages pharmacists to provide consumers with the guide when filling prescriptions for the dangerous category of painkillers.

For additional information about the FDA’s black box warning requirement, read the CNN.com article, “FDA Requires ‘Black Box’ Warning on Painkillers.”

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