The FDA has followed the lead of the CDC in cautioning doctors about prescribing opioid pain relievers. Short-acting narcotics will now come with boxed opioid warnings about misuse, abuse, addiction, overdose and death. Longer-acting narcotics already come with such boxed warnings.
Short acting or immediate-release opioids include drugs like codeine, hydrocodone (Dolagesic, Lorcet, Lortab, Norco, Vicodin) or oxycodone. These drugs are fast acting and ease pain for four to six hours.
Long acting narcotics include methadone, levorphanol and controlled-release formulations of oxycodone (OxyContin), oxymorphone (Opana ER), fentanyl (Duragesic), methadone (Dolophine) and morphine (Avinza). The effects can last from eight to 24 hours or even longer.
The FDA’s Boxed Opioid Warnings Will be Scary:
Expect something like this with short-acting opioids:
“Hydrocodone exposes patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death.”
Doctors will be discouraged from prescribing opioids unless they think the pain is really severe and for which “alternative treatment options are inadequate or not tolerated.”
In addition, the FDA will require that all narcotics carry a warning about drug interactions with certain other medications that could trigger something called serotonin syndrome. This condition can cause agitation, confusion, rapid heartbeat, elevated blood pressure, uncontrollable muscle contractions and elevated body temperature. Nausea, vomiting, incoordination and even hallucinations can also occur with serotonin syndrome, and severe cases can lead to unconsciousness and sometimes death.
The Impact of the FDA’s new Opioid Warnings:
We suspect that between the CDC’s recent Guideline about opioids and the new FDA warnings, many physicians will be reluctant to prescribe opioids at all, even when patients are in substantial pain. In addition, patients will be reluctant to take narcotics even if they are really hurting. There is already a great fear of addiction for many patients, and this is likely to scare them even more.
Will People in Pain Suffer Because of Opioid Warnings?
We recognize that there is a huge drug abuse problem in this country. It includes illicit drugs like cocaine and heroin as well as prescription opioids. Sadly, though, many people who are in severe pain may now have a much harder time accessing needed medicine. A veteran who has suffered grave injuries in Iraq or Afghanistan may find it harder to get pain relief. Someone who has had numerous surgeries and remains in pain could also suffer. And terminal cancer patients suffering severe pain may be afraid to take a narcotic for fear of “addiction.”
It will be interesting to see whether the new CDC Guideline and FDA warnings curtail abuse without causing people in severe pain to suffer.
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