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The Food and Drug Administration recently announced changes in the protocol (the "label") for extended-release and long-acting versions of opioid drugs, including the often-abused Oxycontin.

Addiction, overdose, and death among users of pain-killing opioid drugs has become a major public health problem in the USA. On September 10 the Food and Drug Administration announced changes to its labeling policies for the most commonly problematic extended-release and long-acting versions of opioid drugs such as Vicodin and Oxycontin.

Which drugs are affected by the new rules?

The FDA is changing rules for prescribing codeine, fentanyl (sold under the brand names Fentora, Duragesic, and Actiq), hydrocodone (sold as Vicodin, Norco, Lortab, and Lorcet), hydromorphone (Exalgo, Dilaudid), meperidine (Demerol), methadone (Methadose, Dolophine), morphine (Ora-Morph SR, MS Contin, Kadian, and Avinza), and oxycodone (OxyContin, Percocet, and Roxicodone).

The new rules apply to all of the patch, extended release (ER), and long-acting (LA) versions of the drugs. The FDA is not changing rules for the fast-acting versions of these drugs.

Why is the FDA concerned about the use of these medications?

The extended-release and long-acting versions of these drugs keep a small amount of the drug in the user's system essentially all the time, greatly increasing the likelihood of becoming dependent on the drug, or needing an ever-increasing dosage of the drug to achieve pain relief. The FDA is creating the new regulations in hopes that fewer people will become addicted.

There are also increasing numbers of reports of liver damage, sometimes resulting in death or requiring a transplant, among users of medications that contain both an opioid drug and Tylenol (acetaminophen), such as Lorcet, Lortab, Norco, and Vicodin, which combine hydrocodone and Tylenol, and Percocet, which combines oxycodone and Tylenol.

Is the FDA banning these medications?

No. The FDA is only changing the rules about how these medications can be used. Doctors are no longer permitted to prescribe the extended-release and long-acting versions of these medications for "as needed" pain relief. They are now only to be used in cases in which the fast-acting versions of the medications are inadequate or ineffective.

The rules are likely to indicate that the doctor must recommend a non-steroidal anti-inflammatory drug, typically an over the counter medication like Tylenol, Ibuprofen, or even Aspirin first, then a fast-acting version of the opioid drug, and only as a last resort a long-acting version of these opioid drugs.

The FDA is also requiring drug companies to make further clinical testing of these medications to see whether they can cause hyperalgesia, super-sensitivity to pain, after long-term use, and to document addiction, overdose, and death among users of their products.

The FDA will place a "black box warning" on these medications warning of neonatal addiction syndrome. Pregnant women that their unborn babies can become addicted to the drugs if the mother takes the drug during pregnancy. Babies born addicted to opioid drugs may not show enough interest in feeding, tremble, breathe rapidly, or constantly cry in a high, shrill pitch.

But Isn't This What Doctors Do Now?

The new FDA rules won't really make a big difference in the way doctors prescribe these drugs, since most doctors avoid giving their patients extended-release meds for "as needed" use now, without regulations requiring them to do so.  The requirement that the drug companies run new trials to see if the prolonged use of these medications actually increases sensitivity to pain, however, may make a big difference in the actual use of these drugs in the future.

Opioid drugs offer effective pain relief, at least for a short time, for most of their users, but the potential for complications is high. Always work with your doctor to use these medications effectively, in the lowest doses and for the shortest times possible.

  • FDA, FDA announces safety labeling changes and postmarket study requirements for extended-release and long-acting opioid analgesics:New boxed warning to include neonatal opioid withdrawal syndrome. www.fda.gov, 10 September 2013, accessed 11 September 2013.
  • Photo courtesy of Rubin 110 on Flickr: www.flickr.com/photos/rubin110/1597526657