New rules for opioid painkiller labeling announced by FDA.

Many of the nation’s most widely circulated papers, as well as several websites, covered the Food and Drug Administration’s Tuesday announcement altering opioid painkiller labeling requirements. All of these sources quote agency officials such as FDA commissioner Margaret Hamburg and Dr. Douglas Throckmorton, deputy director for regulatory programs at the FDA Center for Drug Evaluation and Research. The Washington Post(9/10, Dennis, 4.39M) reports that on Tuesday, FDA detailed its new tougher warning label requirements for opioid painkillers “as part of an effort to combat the rampant addiction and misuse that lead to thousands of deaths each year.” The stricter requirements apply to all opioid painkillers, both long-acting and extended-release varieties. Speaking with reporters on Tuesday, Hamburg said, the “FDA is extremely concerned about the inappropriate use of opioids, which has reached epidemic proportions in the United States and has become a major public health challenge,” but she added that the medical benefit the drugs provide patients in pain cannot be ignored. Hamburg said that a balance must be struck “between their benefit in treating patients with pain and the risks associated with misuse, abuse, addiction, overdose and death.”

        The heart of the changes are “a modification of the language on what kind of pain the drugs are supposed to be prescribed for,” the New York Times (9/11, Tavernise, Subscription Publication, 9.44M) reports. Currently, labels indicate “the drugs should be used for moderate to severe pain,” which Dr. Throckmorton said was not right. According to Throckmorton, “What is moderate to me could be severe to you,” and the labeling change “will say that the drugs should be reserved for use in patients who do not have other treatment options, and be used for management of pain that is ‘severe enough’ to require round-the-clock treatment.”

        The Los Angeles Times (9/11, Girion, Healy, 3.07M) adds that Hamburg said that “drug manufacturers will also have to conduct new research aimed at identifying what doses and modes of use are most likely to harm patients.” The FDA is hoping to change the practice of prescribing the opioids to patients for use on an “as needed” basis. The new guidelines are not formal prescribing restrictions on physicians, but agency “leaders made clear they wanted to discourage physicians from prescribing the medications for anything other than ongoing, intractable pain,” encouraging physicians and patients to not only focus on subjective pain levels, “but on how long pain persists and on other treatment options” as well. The Times notes that physicians will retain “broad latitude to prescribe the drugs ‘off-label’ where they” believe it’s medically warranted.

        New boxed warnings on the risks surrounding taking the drugs while pregnant will also be included, reports the Wall Street Journal (9/11, Catan, Martin, Subscription Publication, 5.33M). The FDA has taken action, Hamburg said, “to combat the crisis of misuse, abuse, addiction, overdose and death from these potent drugs that have harmed too many patients and devastated too many families and communities.” The new warnings do not affect immediate-release painkillers.

        Bloomberg News (9/11, Edney, 1.41M) includes data from the Centers for Disease Control and Prevention that notes the involvement of prescription painkillers in “14,800 overdose deaths in 2008, more than cocaine and heroin combined.” Drug manufacturers will also be required “to conduct new post-market studies on the abuse potential of their drugs and on the possibility that users develop an increased sensitivity to pain.” One year ago the agency started “requiring risk mitigation strategies of extended-release and long-acting opioids.”

        The AP (9/11, Perrone) notes that in a statement, Throckmorton said the changes describe “the risks and safety concerns associated with `extended release and long-acting’ opioids” more clearly, and they “will encourage better, more appropriate, prescribing, monitoring and patient counseling practices.” Also reporting on the FDA announcement are the CBS News (9/11, Castillo, 5.42M) website, CNN (9/10, Kounang, 11.58M), the NPR (9/11, Stein, 405K) “Shots” blog, Time (9/10, Szalavitz, 13.36M), CQ (9/11, Adams, Subscription Publication, 530), HealthDay (9/11, Reinberg, 2K), MedPage Today (9/11, Fiore, 185K), Medscape (9/11, Lowes, 187K), and the Fayetteville (NC) Observer (9/10, Ramsey, 141K).