FDA released a statement on Tuesday saying that all fast-acting opioid pain medicines will be required to have the strongest warning about their risks including the risk for abuse, addiction, overdose and possibly death. Immediate-release opioids are the most commonly prescribed, and make up 90 percent of the opioid market, the FDA said.
Advertisement
The labels for immediate-release opioids will now say that they should only be prescribed when there are no alternative treatments.
FDA Commissioner Robert Califf in a release described opioid addiction as one of the most “urgent and devastating public health crises facing our nation” and adding more warnings was just part of a layered strategy in addressing the concern on the heels of criticism for not taking enough initiative to counter the abuse.
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 dosing information also provides clearer instructions regarding patient monitoring and drug administration, including initial dosage, dosage changes during therapy and a warning not to abruptly stop treatment in a physically dependent patient.
The current relabeling action by the FDA is similar to the action taken by the agency in 2013 for extended release/long-acting (ER/LA) opioid analgesics.
The new rule requires opioids to be reserved for severe pain where non-opioids or opioid combination products are inadequate or not tolerated by patients.
During a call with reporters, Califf and Doug Throckmorton, a deputy director in the FDA’s Center for Drug Evaluation and Research, said the new warnings should help give doctors more information to better prescribe opioids.
Earlier this month, The Centers for Disease Control and Prevention (CDC) announced new voluntary guidelines for medical professionals about when and how much opioid medication is appropriate to prescribe for chronic pain. The FDA continues to increase the pressure on the prescription of opioids. It is also one of the many steps that FDA is planning to take this year as a part of the plan to reverse the epidemic.
“Today’s announced changes to the labels of opioid products will finally reflect what we have known about these drugs for decades-they are unsafe and addictive and can lead to dependency, overdose and death”, Markey said in a March 22 statement. “It has taken FDA far too long to address the grave risks of these drugs that have claimed the lives of thousands this year alone”.
And increasingly, people who develop a dependence on prescription medications, whether taken on doctor’s orders or obtained illicitly, turn to cheaper street heroin to forestall painful withdrawal symptoms.
Advertisement
The changes come as the FDA works to assess how it approaches the druga while fighting the opioid abuse epidemic and still giving patients access to quick pain relief medicines.
