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In an effort to stem the epidemic of prescription drug abuse, the Food and Drug Administration will require its strongest warning on immediate-release opioid painkillers. The "black box" warning will alert users to the "serious risks of misuse, abuse, addiction, overdose and death" involved with taking opioids, a class of painkillers that includes morphine, Vicodin and Percocet. The warnings will appear on immediate-release painkillers, which are taken every four to six hours. (Szabo, 3/22)

Federal health regulators will add their strongest warning labels to the most widely prescribed painkillers, part of a multi-pronged government campaign to stem an epidemic of abuse and death tied to drugs like Vicodin and Percocet. The Food and Drug Administration announced Tuesday plans to add a boxed warning — the most serious type — to all immediate-release opioid painkillers, including some 175 branded and generic drugs. (3/22)

In a briefing for reporters, FDA Commissioner Robert Califf called opioid addiction one of the most "urgent and devastating public health crises facing our nation" and said the new labels were just part of the government's larger strategy for addressing it. But Sen Edward Markey (D-Mass.), who delayed Califf's confirmation while he demanded that the FDA overhaul its approval process for opioid medications, issued a statement saying that "the labels given by the FDA have done little to prevent opioid addiction. Unfortunately, it has taken the FDA far too long to address the grave risks of these drugs that have claimed the lives of thousands this year alone." (Bernstein, 3/22)

The actions follow separate FDA requirements unveiled last month, including that any new opioid go before an outside committee of experts unless the product has abuse-deterrent properties. In 2013, the agency mandated labeling changes for extended-release and long-acting opioids, which generally pack a larger load of medicine and tend to be favorite choices of addicts. But the immediate-release versions make up about 90% of the market, said FDA officials. The new rules—expected to go into effect by the end of the year, following comment—clarify that immediate-release opioids should be reserved for severe pain with inadequate treatment alternatives, the agency said. (Beilfuss and Burton, 3/22)

Califf said the FDA wants to warn doctors and patients about the dangers of the drugs while ensuring they remain available for patients who need them to alleviate pain. However, Califf stressed the drugs should be reserved for severe pain for which no alternatives are available. In addition to the risks of addiction and overdose from opioids, the new labels will also warn that chronic use of the drugs by pregnant women could lead their newborns to suffer from neonatal opioid withdrawal syndrome. (Stein, 3/22)

“Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids,” Dr. Robert Califf, the FDA’s new commissioner, said in a statement. (Scott, 3/22)