FDA - Focus On Opioid Manufacturer REMS FDAAA

Updated September 15, 2016

The original post didn't age well (broken links).

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Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids (FDA.gov)

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If you're involved in or follow opioid manufacturing, you'll want to follow the FDA's focus on manufacturers of certain opioid drug products. FDA indicates that these drugs will be required to have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drugs continue to outweigh the risks. The affected opioid drugs include brand name and generic products and are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. The FDA has authority to require a REMS under the Food and Drug Administration Amendments Act of 2007 (FDAAA) when necessary to ensure that the benefits of a drug outweigh the risks. You can expect to hear more about this over the next several months from the FDA.

More FDA Information About This Topic:
Transcript for FDA's Media Briefing on the Safe Use of Opioids
February 9, 2009 [pdf 52 KF] Audio [5.09 MB MP3]
FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs

Previous Posts:
Opiates Can Kill Kids!

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Opiates Can Kill Kids!

Nobody wants to see kids hurt! So it's important that you read this NBC News article to avoid such a situation, "Prescription opiates and kids: One pill can kill - Glut of drugs fuels reports of poisonings among very young children." Oxycontin and other opiates can poison your kids. Here are some things you need to do . . .

1. Don't spill or drop pills, and if you do, it's critical that you pick them all up, so that they're not eaten by your children.
2. Be sure your painkillers are secure, because one pill is enough to harm or kill.

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Deadly Overdose At Home - Especially alcohol and opioid painkillers

Updated February 14, 2021

Links in the original post broke.

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The biggest risk seems to be mixing alcohol and opioid painkillers (e.g., codeine, morphine). This reflects the growing use of these kinds of painkillers in the home. This Bloomberg article frames the situation nicely, "Drug, Alcohol Mix Increases Medication Error Deaths (Update1). " If you want the research publication information, read this abstract, published in the Archives of Internal Medicine, "A Steep Increase in Domestic Fatal Medication Errors With Use of Alcohol and/or Street Drugs." Bottomline, "findings suggest that a shift in the location of medication consumption from clinical to domestic settings is linked to a steep increase in FMEs [fatal medication errors]. It may now be possible to reduce FMEs by focusing not only on clinical settings but also on domestic settings." 

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