Long-acting Pain Drugs No Longer Approved for Treating Moderate Pain

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Pain drugs will need new warnings to alert patients and doctors about their dangers.

Each year, 16,000 people die of overdoses that include prescription opioids— and the extended-release and long-acting drugs such as Oxycontin or methadone are disproportionately responsible for such deaths. While currently labeled to treat moderate to severe pain, the drugs will now carry warnings that indicate the drugs are to be used only “for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate.” New warnings about the withdrawal syndrome that can affect newborns exposed during pregnancy, which can be life-threatening if not managed properly, will also be included.

The Food and Drug Administration’s (FDA) action is in response to the growing number of overdose and abuse cases related to opioid use; by restricting approval to the most severe cases of pain, the agency hopes to limit access to the drugs, since more prescriptions can lead to wider usage and to dependence or addiction. “The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities,” FDA commissioner Dr. Margaret Hamburg said in a statement.

While a citizen’s petition by a group called Physicians for Responsible Opioid Prescribing (PROP), had called for limiting the drugs’ use to 90 days or less, the agency rejected that idea.  “What we’ve concluded is that we need more information about where risk begins,” said Dr. Douglas Throckmorton, the deputy director of regulatory programs at the FDA at a press conference, explaining that existing data doesn’t suggest a particular dose or duration at which risk becomes problematic. The FDA is also requiring that manufacturers conduct post-marketing studies to try to answer these questions.

“I would hope that [the new label] would help improve careful appropriate prescribing of these medications, which have unquestioned value in appropriately chosen patients,” Throckmorton said.

15 comments
KayleeFoley
KayleeFoley

Most of these overdose deaths occur when the person using the opioid is using it irresponsibly.  When taken responsibly, per doctors instructions, these medications are rather safe. However, when a person uses them with alcohol, other illegal drugs, other prescription drugs that their doctor doesn't know about, or misuses them (taking too much or snorting, smoking or shooting up) then they can be deadly. If a patient refuses to follow the instructions that are clearly labeled on the package then it's their problem, their responsibility. 

I don't mean to be insensitive, and I am deeply sorry to those who have lost loved ones from overdoses, but severely limiting these medications will have major repercussions as well. For example, I suffer from chronic pain. I have several back issues that cannot be fixed with surgery at this time. I take 2 opioid medications to manage my pain. The doses that I take are conservative and I have been taking the same doses for 5 years. They do not eliminate my pain but they do make it bearable. If I were to be restricted from having these medications my quality of life would drop. I would be in miserable agony. The medications that I have allow me to work, they allow me to be a mother to my son, they allow me to live a somewhat normal existence. 

My point is that if we get carried away we may severely diminish many patients quality of life. I think that doctors prescribing these medications should educate their patients on the dangers of overdosing and mixing opiods with alcohol and other medications. Doctors should monitor patients, have them sign a contract stating that they will take their medication as prescribed. Their should be frequent follow ups and random urine tests and pill counts. Patients taking their medication honestly would have nothing to fear. People who are not compliant would be dropped as patients. These records should be available to other doctors as well, a federal database should be created. If a patient is non compliant more than once then they should be flagged in the system. If every doctor did this and the database was available for every doctor to see, then I believe that  abuse and the sale of these drugs on the street would decrease quite a bit. Also, make it mandatory for EVERY state to have a prescription drug monitoring database. 

Obviously there will still be some abuse, just like anything else, some people will still find a way to divert these medications but this is a solution that won't cost chronic pain patients their lives and dignity. 

becker.david2
becker.david2

Dr Throckmorton and the FDA wrongfully assume that limiting opioid use will lead to better pain care and less drug abuse- but the evidence is clear opioids have already lead to rapid rise in street heroin and since doctors refuse to have education in pain care- they wont know how to treat people in pain without their love of opioids. The FDA and government- like their pals in medicine cant get it right and continue in  misdirection. Their own report on Opioid REMS is clear proof that tdont know what they are doing.

StevenHillmuffin
StevenHillmuffin

Darn.....well this is bad for me, 'cause I've been taking a small dose of methadone for my arthritis for years ....(sigh)...I've been meaning to switch to something with less of a withdrawal problem anyway.....so it looks like it's that time. The hazard is not surprising I guess....I once OD'ed for emotional reasons...luckily the paramedics were close & I wasn't alone...

BTW Maia....have you done an article on the Narcan program? You can have a Narcan kit at home now - Public Health gives you a 45 minute training, and with the kit you can save lives in an OD pretty much effortlessly - one shot and the person is waking up.....Good both if you know heroin addicts or have a family member that has been prescribed these meds....


JenniferBolen
JenniferBolen

Your article headline is very misleading. "Severe enough to warrant around the clock medication" does not mean it will not be available for someone with what they may characterize as  moderate pain. In other words, a person might have moderate pain (they are not crying or doubled over in their doctor's office but they hurt constantly and their life is significantly impaired without medication - they cannot work or care for their family) and this type of pain is easily evaluated by a properly trained clinician as "severe enough to warrant around the clock medication" for which a long-acting opioid that you take once or twice per day (instead of a short acting opioid which would require dosing as much as six times through the day) would be a medically necessary and reasonable choice for the clinician and patient. You write as if the overdose deaths are tied only to long acting preparations and this is not true. Most fatal overdoses are polysubstance, and many include alcohol and short acting preparations that provide immediate release of the drug. The whole matter is quite complex and patient responsibility (or lack thereof) is a major component of the problem. Through your misleading headline you are literally sentencing many good and responsible patients to a punishment they do not deserve. Shame on you for not knowing more about this issue before you write about it. Shame on Time for allowing you to do so.

nicmart
nicmart

A century ago, in 2014, Americans lost the freedom to self medicate. It was, quite literally, a fatal mistake.

Hell_on_wheelz
Hell_on_wheelz

People need to put their long noses out of other people's business.  You have outside groups worrying about "other people getting too many OPIOD pain pills" or "other people's smoking". 

Give it a rest, zealots.  Worry about your own backyard and stay out of mine!  

Case in point - e-cigarettes.  Did you know you can get non-nicotine stuff to go in the e-cigs?  I quit smoking analogs (real cigs) and went to the e-cigs.  The base is the same as the stuff in a nebulizer, the method of delivery the same.  It wasn't long before I found that it didn't matter if the stuff had nicotine in it or not - the enjoyment level was the same.  So I dispensed with the nicotine.  

NOW here is the kicker.  An acquiantance was ALL for this idea UNTIL he learned that my favorite flavors were TOBACCO. "Oh NO, that's BAD!!!!"  Excuse me?  So "Cherry Pie" or "Pina Colada" or "Rum Mojito" is ok BUT because the -flavor- is "Imported Cuban Cigar"  (with no nicotine) it has to be bad.  

ZEALOT.

People on the "OPIODS are BAD" train are just as unreasonable.  The problem with an outside group of people (none of whom have uncontrolled, barely controlled or ONLY controlled by "X" class of drugs chronic pain) is they have NO FRAME of reference for making the types of decisions described in the article above.  Like my acquaintance, the tobacco hater, they are programmed to react to "opiates are bad" (because they make you high?) and will take every opportunity to have them removed from the market or at least made less available.

There is a radical difference between taking an analgesic to "get high" (abuse) and one for "pain relief".  I've had some that have only gotten me high but did NOTHING for the pain.  When you are in pain, the last thing you want to be is high AND in pain.  People with chronic pain are all too familiar with the need to switch-up pain relievers over time (habituation) and know that opiods are just ONE tool in the analgesic tool box. Patients with chronic conditions AND their doctors need to use WHATEVER works for the situation for however long is necessary and the long-nosed zealots need to stay out of the picture. 

MuzzyLu
MuzzyLu

Medical marijuana is better for pain than most pharmicutical drugs. Most people would be better off if they just took a little marijuana to smooth out the edges. Nobody dies, and cannabis helps reduce pain, calms you down, and ups your mood. I have back pain and medical marijuana does help. Instead of medicating with opiates, booze, or other harmful drugs, medical marijuana taken in edibles really works for me and many others.

Great e-book on medical marijuana: MARIJUANA - Guide to Buying, Growing, Harvesting, and Making Medical Marijuana Oil and Delicious Candies to Treat Pain and Ailments by Mary Bendis, Second Edition. This book has great recipes for easy marijuana oil, delicious Cannabis Chocolates, and tasty Dragon Teeth Mints.

Karen Lawrence Coleman
Karen Lawrence Coleman

Reining in the script docs and letting pharmacists focus on what they learned in school would go a long way to alleviating that problem.

thedoctorisin
thedoctorisin

And yet, every hospital and physician is now rated by Medicare on how well they treat pain. Like a car dealership, only 5's count, so keeping people pain free MOST of the time doesn't count, it must be ALL THE TIME.


Which is ridiculous. What is interesting is all of these increasing problems with prescription narcotics started after pain became the 5th vital sign. I am not saying let patients suffer. In fact by their nature most physicians and nurses work to reduce people's pain. But now, if I feel a patient is not truly in pain, but just wants the drugs, I am penalized for "letting him suffer", even in the absence of any objective sign of pain. I have seen it advocated to give pain meds if the patient asks for them, even if he can barely keep his eyes open 

rpearlston
rpearlston

The risk begins in the brains of those who are hard-wired to abuse any substance.  Yes, that's right, this isn't a problem about pain meds - this is a problem of abuse, and ONLY of abuse.  Once governments recognize this and change their policies so as to help abusers and not punish those people who live with chronic and severe pain, there will be no needs for such warnings.

Stop punishing us (I have 3 types of arthritis, and between them, they affect every part of my body) and start dealing with the neuropsychobehavioural problem that is addiction.  That's the ONLY way to handle this.

StevenHillmuffin
StevenHillmuffin

@JenniferBolen : Well, this is true, but she's trying to keep it short....it IS a complex issue, my goodness! And here again, it's important for the user to have a secure place to keep the meds so they don't fall into the wrong hands....do some states require a drug safe or a lockup like with guns? This might be a good way to keep the meds from being stolen......

StevenHillmuffin
StevenHillmuffin

@MuzzyLu : I'm all for cannabis, but some of us don't tolerate THC - can't wait 'till the all CBD strains are popular!

becker.david2
becker.david2

@thedoctorisin Please- doctors refusal to have education in pain care is the prime reason for poor pain care. Its doctors who are ridiculously irresponsible when it comes to pain care- your Cnidian biomedical antipathic medicine is a failure and medicine has the gall to brag about their achievements.

StevenHillmuffin
StevenHillmuffin

@thedoctorisin : Well, that's no good, but hopefully you'll be able to prescribe cannabis soon.....

A clinical question: Do you find that buprenorphine can replace methanone in some patients? I'd like to switch over 'cause I take 10-15 mg a day of the former, and find the withdrawal extremely unpleasant like everyone else....Of course it's universally avaliable but for traveling, etc buprenorphine might be less regulated. (As you know, in some countries they really hit ya at customs if you show up with a powerful opioid).