The FDA has followed the lead of the CDC in cautioning doctors about prescribing opioid pain relievers. Short-acting narcotics now come with boxed opioid warnings about misuse, abuse, addiction, drug interactions, overdose and death. Longer-acting narcotics also come with such boxed warnings. When acetaminophen is included with an opioid, there is a warning about liver toxicity.
Short acting or immediate-release opioids include drugs like codeine, hydrocodone (Norco) 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, Xtampza ER), oxymorphone, fentanyl (Duragesic), methadone (Dolophine) and extended-release morphine. The effects can last from eight to 24 hours or even longer.
The FDA’s Boxed Opioid Warnings Are Scary:
Short-acting opioids with acetaminophen carry scary warnings:
“Hydrocodone bitartrate and acetaminophen tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.”
Doctors are discouraged from prescribing opioids unless they think the pain is really severe:
“Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of moderate to moderately severe pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.”
Limitations of Use:
“Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses, reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]
“Have not been tolerated, or are not expected to be tolerated,
“Have not provided adequate analgesia, or are not expected to provide adequate analgesia”
In addition, the FDA requires 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.
FDA’s NEW Opioid Warnings:
On July 31, 2025 the FDA decided that the old warning labels were not adequate:
“The labeling changes will include the following updates:
- Clearer Risk Information: A summary of study results showing the estimated risks of addiction, misuse, and overdose during long-term use.
- Dosing Warnings: Stronger warnings that higher doses come with greater risks, and that those risks remain over time.
- Clarified Use Limits: Removing language which could be misinterpreted to support using opioid pain medications over indefinitely long duration
- Treatment Guidance: Labels will reinforce that long-acting or extended-release opioids should only be considered when other treatments, including shorter-acting opioids, are inadequate.
- Safe Discontinuation: A reminder not to stop opioids suddenly in patients who may be physically dependent, as it can cause serious harm.
- Overdose Reversal Agents: Additional information on medicines that can reverse an opioid overdose.
- Drug Interactions: Enhanced warning about combining opioids with other drugs that slow down the nervous system—now including gabapentinoids.
- More Risks with Overdose: New information about toxic leukoencephalopathy—a serious brain condition that may occur after an overdose.
- Digestive Health: Updates about opioid-related problems with the esophagus.”
How will the New Opioid Warnings Impact Physicians?
We suspect that the new FDA warnings will discourage many physicians from prescribing 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.
We have talked to a surprising number of patients who have bragged that they avoided opioids even after major surgery. Some experienced significant pain after knee replacement surgery or even abdominal operation. They were proud that they toughed it out. It that a good thing?
Scholars attribute the German philosopher, Friedrich Nietzsche with the phrase:
“What doesn’t kill you, makes you stronger”
I am not sure that applies to pain, however.
A Reader Describes What It’s Like To Suffer Intractable Pain:
Q. I have complex regional pain syndrome, fibromyalgia and rheumatoid arthritis that put me in intractable pain 25 years ago. Until recently, I have managed with the opioids my doctors prescribed. Now that the doses are being lowered, I am in severe pain again.
I often wonder: if I have to take my life because I can no longer stand the horrible pain, how will I do it? It frightens me that I am thinking this way.
I suspect others with chronic pain are too. The DEA, FDA and CDC are punishing us by taking away our medications, even though we have done nothing wrong. The changes intended to restrict opioids are harming the most vulnerable.
A. We have heard from hundreds of patients like you who have been deprived of opioids for their excruciating pain. The government does not seem to understand how to help people with severe chronic pain.
The FDA is poised to require changes to the labeling of opioid pain medications. The new information will have stronger warnings about the risks of addiction, misuse and overdose. In addition, labels will stress that prescribers should avoid long-acting or extended-release opioids unless there are no other options.
These changes may make life even more difficult for people like you with persistent agonizing pain. The FDA will remind prescribers “not to stop opioids suddenly in patients who may be physically dependent, as it can cause serious harm.”
You can find other comments from readers at this link:
“How Will People in Severe Pain Cope Without Narcotics?“
Will Other 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, heroin and fentanyl 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 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.” Of course that is tragic.
It will be interesting to see whether the new FDA warnings curtail abuse without causing people in severe pain to suffer.
Share your own thoughts below in the comment section and please vote on this article at the top of the page.
