TUESDAY, Sept. 10 (HealthDay News) — The U.S. Food and Drug Administration is requiring all extended-release, long-acting narcotic painkillers to carry revised warning labeling, the agency said Tuesday.
One warning restricts the use of these painkillers to those who need daily, around-the-clock, long-term pain management and for whom non-narcotic drugs haven’t worked. A second warning alerts pregnant women to the danger of narcotic withdrawal syndrome in their newborns.
“Today FDA is announcing a set of significant measures to enhance the safe and appropriate use of extended-release and long-acting opioid analgesics,” FDA commissioner Dr. Margaret Hamburg said in an afternoon press conference.
Oxycontin, Opana ER, Embeda, Palladone and MS Contin fall into this class of drugs. The medications contain narcotics such as oxycodone or morphine.
These “black box” warning changes will continue to ensure the benefits of these drugs outweigh their risks, Hamburg said. “However, FDA is extremely concerned about the inappropriate use of opioids, which has reached epidemic proportions in the United States,” she added.
Although much of the misuse is illegal, even prescribed use can lead to addiction, overdose and death, she said.
“In 2010, an estimated 16,651 people died because of abuse and misuse of opioid drugs,” Hamburg said. “There is an increase of more than 300 percent over the past decade. And for each death there is an additional 10 treatment admissions, 32 emergency department visits and 825 nonmedical users of these drugs.”
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