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# IR Opioid Label Changes Answer Purdue Petition
- URL: https://www.fdaweb.com/ir-opioid-label-changes-answer-purdue-petition/
- Published: 2016-03-22T12:00:00.000Z
- Updated: 2026-09-14T20:50:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135154

> At the same time that it [required](http://www.fdaweb.com/login.php?sa=v&aid=D5135153&cate=&stid=%241%247S%2F.CC5.%24n7rZJly57ZE8QntgufakN%2F) sweeping safety labeling changes for immediate-release opioid analgesics, FDA [granted](https://www.regulations.gov/contentStreamer?documentId=FDA-2014-P-0205-0006&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) in part a Purdue Pharma 1/17/15 petition calling for such changes, although not for the reasons cited by Purdue. The petition had called on the agency to:  
> promptly exercise its authority to seek and, if necessary, impose safety labeling changes on immediate-release opioid analgesics that parallel the final safety labeling changes started on 9/10/13 for extended-release and long-acting (ER/LA) opioid analgesics; and assure that the indications for use and other safety labeling information for immediate-release and extended-release/long-acting opioid analgesics convey the same Warnings and Precautions regarding the risks of opioid use and misuse.  
>  
> The agency letter says the petition is granted because most of the immediate-release opioid analgesic safety labeling changes will parallel those for extended-release/long-acting products. “However,” it says, “to the extent that certain aspects of the ER/LA opioid analgesic labels will not apply to IR opioid analgesics (e.g., certain limitations of use), or will not convey the ‘same warnings and precautions regarding the risks of opioid use and misuse,’ and to the extent that petitioner asks FDA to base IR opioid safety labeling changes on the data and arguments in the petition, those aspects of the petition are denied.”  
>  
> Purdue argued for its position that IR opioid analgesics are associated with the same potential adverse consequences as ER/LA products in two ways, FDA says. First, it presented data from several sources to support its conclusion that IR opioids have the same risks “with comparable or higher incidence” than ER/LA opioids. Its second argument criticized FDA’s determination that ER/LA opioids have disproportionate risks.  
>  
> “The agency does not agree with petitioner’s data analyses,” the FDA letter says. “FDA has concluded that the described studies are fundamentally deficient and cannot adequately address whether ER/LA opioid analgesics and IR opioid analgesics have similar abuse profiles. Further, the agency’s conclusion remains that ER/LA opioid analgesics, as a class of drugs, present disproportionate risks to users: many ER/LA opioid analgesic drugs contain more active ingredient than IR analgesics on a per-tablet basis, and the long-acting nature of ER/LA opioid analgesics means that ER/LA patients who suffer negative consequences from their use … are in danger for a longer period of time than IR patients because they will continue to have circulating levels of opioid for a much longer time, thereby increasing the likelihood of serious outcomes. Additionally, the available higher per dose strength makes ER/LA products more attractive to abusers, although the risks of misuse, abuse, addiction, overdose, and death are present for all opioids.”  
>  
> While Purdue did not successfully demonstrate that IR opioid analgesics have a comparable or higher incidence of risks than ER/LA opioids, the letter concludes, the agency agrees that IR opioids are associated with substantial and continued abuse in the community, and that the risks of the drugs present an important public health problem that needs to be addressed. For that reason, it is requiring safety labeling changes for IR opioids.