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Sept. 18 — Sen. Edward J. Markey (D-Mass.) and a bipartisan group of senators Sept. 18 sent a letter to the FDA questioning the agency's approval of the opioid prescription painkiller OxyContin for children as young as 11 years old.
In August, the Food and Drug Administration approved Purdue Pharma LP's OxyContin (oxycodone) for use in pediatric patients 11 to 16 years old for pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
The senators said they are concerned about the approval and asked the FDA why it approved the pediatric indication of OxyContin without the benefit of an independent advisory committee review.
Also, the senators said it isn't clear whether the FDA sought any information about the potential for addiction and abuse by children. Children, whose brains aren't yet fully developed, are especially vulnerable to drug dependence and abuse, they said.
“The country is in the midst of an opioid abuse crisis, with more than 2 million Americans aged 12 or older abusing or dependent on opioids,” the letter said. “Opioid overdoses, once almost always due to heroin use, are now increasingly due to abuse of prescription painkillers like OxyContin. We recognize that, in serious cases, children may need appropriately approved and prescribed narcotics. But an increase in the availability of opioids like OxyContin to children—and the potential for abuse—poses a serious U.S. public-health issue.”
• an explanation of why the FDA decided to forgo an advisory committee meeting on the pediatric indication;
• information on any studies the FDA required Purdue Pharma to conduct before approving the pediatric indication;
• an explanation of whether, and if so, how the FDA considered the issues of abuse or addiction by children prescribed OxyContin before the agency approved the indication;
• information on whether the current black box warning for OxyContin is adequate for pediatric use;
• information on the types of medical conditions for which pediatric use of OxyContin is indicated, as well as those for which it isn't indicated;
• a description of how the agency plans to ensure that patients treated with opioids are managed by experienced care teams, and what efforts are under way to educate providers about the pediatric-specific risks associated with the use of opioids;
• a description of what information physicians are required to provide to parents of children receiving OxyContin, including information about potential abuse or dependency; and
• an explanation of how the FDA will be tracking abuse and dependency caused by pediatric use of OxyContin.
Sens. Kelly Ayotte (R-N.H.), Joe Manchin (D-W.Va.), Dianne Feinstein (D-Calif.), Tim Kaine (D-Va.), Angus King (I-Maine), Jeanne Shaheen (D-N.H.) and Dick Durbin (D-Ill.) also signed the letter.
On Sept. 9, Manchin sent a letter to the Senate Health, Education, Labor and Pensions Committee urging it to hold a hearing on the FDA's decision to approve the pediatric use of OxyContin. Manchin also wrote to the FDA in August to express his outrage over the approval decision.
In its approval letter to the manufacturer, the FDA said it will use all available tools to help prevent misuse and abuse of OxyContin. The agency also said it will require Purdue to conduct postmarketing studies aimed at assessing the safe use of the drug in children.
The approval aids prescribers by providing information on how to safely prescribe OxyContin for a certain population of pediatric patients, the FDA said. OxyContin joins Duragesic (fentanyl) as the only extended-release opioid products that are FDA-approved for pediatric use.
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