FDA mandates stricter warning labels on opioids to address long-term use risks

Scripps News ^ | 8:12 AM, Aug 02, 2025 | By: Justin Boggs

[E. Pluribus Unum]

The FDA is mandating new labeling for opioids to better inform patients and healthcare providers about the risks of addiction, misuse, and overdose associated with long-term use.

The Food and Drug Administration will soon require drugmakers to place stronger warning labels on opioids to convey the risks associated with these medications.

The labels will include clearer risk information about addiction, misuse, and overdose; stronger warnings regarding higher doses and their long-term risks; clarified use limits to prevent misinterpretation of long-term use; treatment guidance recommending long-acting opioids only if shorter options are inadequate; advice against sudden discontinuation for physically dependent patients; and information on overdose reversal agents.

RELATED STORY | States push for life-saving fentanyl testing laws amid rising opioid concerns

These changes to label rules come as the FDA claims that OxyContin was approved illegally and without proper study supporting its long-term use. The maker of OxyContin, Purdue Pharma, reached a $7.4 billion settlement for its "manufacturing and distribution of opioids that fueled a nationwide addiction epidemic."

“The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This long-overdue labeling change is only part of what needs to be done — we also need to modernize our approval processes and post-market monitoring so that nothing like this ever happens again.”

The FDA said drugmakers have 30 days to submit labeling updates for review.

[EQAndyBuzz]

“ The FDA is mandating new labeling for opioids to better inform patients and healthcare providers about the risks of addiction, misuse, and overdose associated with long-term use.”

Those of us who use them according to the prescription don’t need a warning label. Those who use them illegally will never read the warning label.

[ComputerGuy]

My tax dollars at work.

[metmom]

EXACTLY!

[maddog55]

Problem solved..who knew all it would was a label.

[Mariner]

I had a “complex” knee replacement in March.

VA sent me home with 90 5mg oxycodone (straight, no tylenol)...baby aspirin sized pills.

The first few days I was taking 2 every 4 hours. The pain was overwhelming.

But I was smart enough to start tapering down and suffering a little more pain each day...when I was down to about 20 of them.

I made it.

But for those who start with severe acute pain and are unwilling to taper, hell awaits them when they are eventually cut off. And they will be.

[1of10]

“according to the prescription”

I think some Drs are better at teaching patients to use
their meds some don't have a clue.

I have no doubt used correctly opiates are safe and effective. Not vax “safe and effective” but really
safe and effective.

But it is a bit more complex than ... take this and call me in the morning.
Drs are so scared of the gov now, it has created a crisis in pain management.
Fentynal is the problem ... not prescriptions.

[cpdiii]

I am a retired hospital pharmacist. Opioids are very good for for short term pain and evil for long term pain In the case of a terminal patient with cancer the addiction is irrelevant. They are dying and thus must be kept pain free. The addiction is of no importance as they are dying and we must at this point keep them pain free.

I well remember a patient on C-West at the Temple VA Hospital, our cancer ward. He was terminal and knew it. He was on incredible doses of morphine for pain control. The doses would have killed most people but he was sane and logical due to months of therapy for pain conrol I mixed them myself down in the pharmacy. He was afraid of the night as he thought that was when he would die. When I had completed my normal duties on night shift, I would walk the halls and sit with him and talk with him. I did him well as a human being of morality. I will miss this man.

[dadgum]

More pain! Fewer choices!!!

Harass the prescribing caregiver over every opioid RX they write.

This BS just drives wore and more chronic pain patients to get their relief from the streets. Which is eventually a death sentence.

People are the problem, not the pain meds.

[A Navy Vet]

Your post brought tears. I just knew there are still good souls out there. Well done, Sir.

[mabarker1]

If these JACKA$$€$ would spend as much time on REAL PROBLEMS like street junkies and stop creating some other barrier for those of Us that need them for valid uses, like being able to get through daily life it would be great.

I have to go to a “Pain Clinic” every month just to get My Rx refilled. It’s a 2 hour round trip from home to the clinic. Then it’s the same old questions every time, with the stupid 1-10 pain level question, where’s the pain at, (every time it is the same as it’s been for 15+ years) then a urinalysis sample before getting the Rx refill sent in to My Pharmacy. Add the visit cost and the urinalysis cost ends up being about $450-500 depending upon what insurance code they use for the visit. The urinalysis bottle in bulk only cost the clinic about $2 and then they ship it to FREAKING kommiefornicata for the actual Test !!!

The technology exists for the clinic to test immediately in the clinic and get the results...

Meanwhile the (see My FRTagline) gets whatever drugs they want from the fedgov pharmacy with no hassle.

[mabarker1]

You are a rare breed. Thank You for being a compassionate person and caring enough to do what You for that Person.🙏🙏

[E. Pluribus Unum]

When I had double knee replacement surgery I found that the pills just made me delerious with pain instead of just in pain. I didn’t bother with them after a couple of days.

[Tacrolimus1mg]

Ding ding - Winner.

It’s true. The problems are pill mill doctors and apathetic pharmacists enabling users.

[Red6]

Can they get a jack in the box with a 3 foot large warning banner stuffed in a prescription bottle?

Turn the lid, and a 3 foot large warning label is blasted into your face.

Can I get a GS-14 position in government for that idea? I have lots of stupid ideas that accomplish nothing but go with the flavor of the day!!!

[ssfromla]

You are very lucky. There are so many people with chronic illnesses and chronic pain that are paying the consequences of the Drs and their billing companies affair with the "opioid epidemic."

Those Drs damn well knew they were being played and they were all in on it.

You never hear one word about their contributions to the schemes. It's all about the addicts.

Not only that but now these same Drs are pushing patients into risky procedures and or surgeries.

Their patients, who want to live a normal life, are willing to jump through the Drs hoops to prove they're not addicts and are facing years of worse pain than they started off with.

I found it surreal when Ozzy Osbourne said that he wish he had never had those surgeries because he said "Parkinson's he could live with but what happened to his body after the surgeries was worse than the original problem," a statement you will hear thousands of times if only they had a voice.

So many who have had enough and can't stand it anymore go to the streets and very many end up dead.

I don't want to hear one damn word about opioids and the dangers if it doesn't include those Drs and their apologies for their part in what happened. It didn't have one thing to do with patients who clearly are not living they are dying in pain, yet they are the ones who are living the consequences of everyone's failure.

I could spit on those self righteous sob's pushing their chest out and pretending they're doing something. They are doing something but it's not what they have you believing they are doing.

They took grandma off her pain pills she'd been on for years and grandma died shortly after.

A beautiful vibrant young lady of 40 jumped through hoops for help and it ended with her having 2 back surgeries and the neck surgery she had gave her sepsis and she died leaving twins of 8 without a mother.

They're all in it for the money if you haven't figured that out. They can't push hundreds of thousands through pain clinics anymore but boy those surgeries and needles in your back sure does pay well from Medicare and Medicaid.

February of 2024. I broke my ankle. I didn't go to the er because I know how you're treated and I'd rather stay at home with my break. About 5 weeks later I was getting around and picked up a large heavy box and my back started hurting. My leg, My foot, hurt with my ankle as big as a softball so in May I finally went to the er. I have been jumping though hoops since. I have 3 herniated discs and so many other problems that I never saw coming and it could happen to any of you. In a blink of an eye you too could lose everything and when you're in pain and the er dr says here take this Ibuprofen. Why? It's in my chart that I'm allergic to them.

I have been on a carousel from hell. I refuse to give them their Frankenstein moment on me.

I will be in chronic pain the rest of my life without any relief. Does that sound fair when there is medicine that would let me be comfortable and have a life? It's ok to give them gabapentin. It's ok to give them muscle relaxers. Did you know that any medicine you take on a regular basis has to be tapered down because of the withdrawal. All meds are like that. Ever heard an uppity Neurologist talk all about the Tylenol for this and that and when you say "Oh yeah, I've been using Tylenol and my migraine is still bad." Then the Dr says without even thinking "rebound headache" so now you're an addict of Tylenol. No, they won't tell you that but it's true.

I'm not being ugly to you but I found your post as a moment to tell the other side of the story. Drs are over billing for expensive procedures because their opioid clinic charade is over and they'll make even more now.

God please forgive them. It's very hard for me to forgive them.

[87FXRC]

Ma,

What do elderly patients do if they can’t get out of the house to go to a pain management facility?

[dkGba]

Per usual punish the innocent 😡

[Mastador1]

Absolutely! You can’t stop a person with an addictive personality, or someone just looking to get high, from misusing a drug, alcohol, or even food, wit a warning label.

[mabarker1]

I’m using My UHC/Medicare Ins travel benefits.

Other than that there’s many local programs via Churches, City, County, State assistance programs, Neighbors and private pay.