Do Americans Want the FDA to Restrict Pain Medications or Educate Consumers on Their Use?

Do Americans Want the FDA to Restrict Pain Medications or Educate Consumers on Their Use?

To reduce the risk of accidental overdose, the makers of Tylenol lowered the recommended daily dose from 4,000 mg per day to 3,000 mg per day. For people taking Extra Strength Tylenol, that means a maximum of 6 tablets per day instead of 8 tablets. Photo by Scott Olson/Getty Images @Dalife

To reduce the risk of accidental overdose, the makers of Tylenol lowered the recommended daily dose from 4,000 mg per day to 3,000 mg per day. For people taking Extra Strength Tylenol, that means a maximum of 6 tablets per day instead of 8 tablets. Photo by Scott Olson/Getty Images @Dalife

The U.S. Food and Drug Administration (FDA) is concerned about people taking acetaminophen. They are so concerned about misuse and unintentional overdose that they are considering restricting access to certain over-the-counter (OTC) pain medications, as well as possibly changing medications’ labeling (rules related to the use and access to a medication) so that they are no longer available without a prescription.

That does not sit well with the vast majority of Americans.

A survey of 1,600 American adults conducted by Clarus Research Group with support from McNeil Consumer Healthcare asked people what they thought about restricting pain medication or educating consumers.

Consumers want education, vs. restrictions to pain medication.  And, that makes sense to most people in pain, who are far better suited to making decisions regarding their own healthcare than relying on sweeping changes from the FDA, particularly with respect to basic OTC pain medications.

The survey found:

  • 77 percent of those under age 60, and 68 percent of those over age 60, prefer consumer education to government restriction as a way to protect people from acetaminophen overdose.
  • 75 percent of respondents under age 60, and 70 percent of respondents over age 60, believe that the FDA should not change its policies to require a doctor’s prescription to buy extra-strength Tylenol or an equivalent store brand.
  • 52 percent of those under age 60, and 45 percent over age 60, believe that requiring a prescription will make it more difficult to access safe pain medications.

“The aging of our population means that more Americans will be faced with persistent pain,” says Cynthia Bens, vice president of Public Policy for the Alliance for Aging Research. “Potential barriers to OTC medication access may have unintended health consequences for seniors who rely on OTC pain relievers that contain acetaminophen to reduce their pain and maintain their quality of life.”

The survey also offered insights into the amount of pain people experience:

  • More than 70 percent of respondents age 60 and over use an OTC pain medication.
  • More than 80 percent of respondents under age 60 use an OTC pain medication.

According to the Alliance, “When used as directed, acetaminophen is safe and effective, but there is a limit to how much should be taken in one day. Taking more acetaminophen than directed is an overdose and can lead to liver damage. The FDA recommends taking no more than 4,000 mg of acetaminophen in a 24-hour period.”

National Pain Report has been covering a wide range of government actions that are intended to increase public safety and decrease the likelihood of adverse events, overdose and death. We’ve also seen the real-life ramifications well-intended policy has on the people these medications are designed to help.

Now, general public opinion is that chronic pain sufferers are drug seekers; physicians are drug pushers; and pharmacists are drug dealers. Yes, a very few bad apples in this world earn these labels, but they are absolutely the exception.

With even greater restrictions potentially on the horizon for acetaminophen, does this mean that these labels will now begin to apply to people who simply need Tylenol?  Are they drug seekers needing saving, or is education a smarter policy choice?

Give us your opinion. Please comment in the Comments Section below the story.


Authored by: Staff

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I wonder what the sales figures are for the OTC pain meds in the past few yrs, since rx pain meds have become more difficult to obtain.


What did they think would happen when feds put there nose in people’s private lives now less pain control people are going to take what they can that helps to me if I had to choose it would be a shorter life with no or less pain over a long miserable life in pain


As a chronic pain patient in Pain Management on and off for 30 yrs I can say if you don’t have chronic pain, you can not comprehend what a day is like for us. Also, here in the Lehigh Valley, good luck trying to find a PC who will even write you a prescription short term. You are sent to Pain Management who won’t give you a prescription with out subjecting you to painful and dangerous facet injections. When you have a heart condition like myself, these aren’t just painful they’re life threatening. So how’s that for a choice, life threatened or non-mobility due to debilitating pain.

Denying affordable, available medication could be a tipping point driving them to find other, perhaps more lethal, ways to manage pain. Let’s hope that a more informed decision can be made. One that does not punish those who are benefitting.

robin birdfeather

For the past 40 plus years I have been first a sufferer with myofascial pain syndrome, then a professional pain management provider using among other things very effective Trgger Point MyofascialTherapy. There is no doubt that the medical profession has, however hesitantly, recognized chronic pain as a disease unto itself. This is a step forward , but way too slowly, doing the actual in depth training of medical professionals in the integrated applications for chronic pain relief.There
are many so called reasons for this needed but slow and often ignorant development and education. It seems obvious that we need much more specific training of medical professionals, particularly MD’s and NDs &
adjuvant providers working as teams.We now have pain clinics around the country who have begun to pull together the needed and varied specialists. Some of these groups are further along than others, however this is a good start. Opposing this movement are many poorly trained doctors who tend to rely on drug company representatives for the many
Rx drugs available that are often not either helpful to the extent needed or are used as a kind of silver bullet approach. Integrated pain management is not as available to people with severe and/or chronic
pain partly because of geography, and partly because of lack of education of the doctors, of the public, and sadly to say, of the politicians making medical decisions they could not possibly understand. It then follows: that the FDA itself is in the fallback position of passing judgments on more readily available and cheaper OTC remedies.People
in chronic pain are most of the time the experts and in almost all cases want fewer prescriptions and pills, not more. In my experience as a provider of self help information as well as hands on Trigger Point work, nutrition suggestions, physical and movement therapies to be done by
the pain sufferer, people are much happier to get useful and individualized information that they can come to trust. If all they are offered is a choice between heavy medications that are then frowned upon by ignorant untrained politicians, by judgmental pharmacists, by medical boards, or can only get some relief from available OTC, it is clearer and clearer that this country needs something akin to the Manhattan Project to bring everybody up to speed, because there are a hundred million chronic pain sufferers right here in the USA. I agree that education without political interference is the single most needed element.


Oh well now regular people will know what it is like to have the government regulating your over the counter pain pills. Now regular people who don’t even take narcotics will be suspect. The last remark about the disabled get left out in the cold is old news, I guess now it’s going to spread to regular people who’s pain is not bad enough to require a specialist, which do to government meddling is becoming more and more impossible. Pain is real and people need to pull their head out of the sand or where ever else it has been to notice the government is trying to run your life more and more every day. We need to recognize chronic pain as a real disease and stop ruining the lives of people in pain. Why don’t they do more research on the narcotics that contain LDN or Low dose naltrexone which helps to keep your tolerance low so they don’t have to prescribe such high doses of opiates which are the only thing that work on serious chronic pain. Many patients have been on long term opiates for chronic non cancer pain but no one listens to them. Now people who aren’t even in that severe pain will know what it’s like to have the government run your lives. Look at that video on You tube about how the Ukraine that limits opiate use to 50mg across the board. Is this the direction were heading in???


Donna M. Harker, please share the link to the Law in your state that says “its now illegal for your doctor to prescribe pain medicine to chronic pain patients.” Honestly, there are no such Laws in any state or at the federal level. The person that told you this was lying to you.

Kathy Hastings

Perhaps this will be the only way for the general public to understand the plight of legitimate pain patients!

I have watched over the last 30 years as the FDA learns more and more about OTC medication like Tylenol and Motrin. A lot of people just assume if its purchased without a prescription then it must be safe in any amount.

Educate and Inform the public and doctors as to the side affects of all medication, Recently I read an article called / the 10 most deadly drugs on the market – all were either NSAIDS, Statins, Tylenol or some other drug that is used by many americans for common medical conditions. Nowhere on the list was opiates or other narcotic drugs used to treat chronic pain. This does not mean narcotics aren’t dangerous when misused and unfortunately too may doctors are prescribing narcotics for conditions other than pain; case in point are the VA Hospitals using opiates to treat PTSD.

Recently the term ” accidental overdose ” has been used in nearly all cases of death by overdose, even last year when the well known actor Phillip Seymour Hoffman died from ingesting heroin the press labeled it as ” accidental ”.It was clearly a case of a heroin overdose by a drug addict that used more to get his high.

Doctors and their patients need to be held accountable and if that means doing more work to make sure patients are not abusing their medicine then its time to put better procedures in place. Pill counts and drug tests are both easy to do yet in the case with the VA nothing was done to keep track of strong medication and the result was death.

The key for all medication is education and accountability for the doctor and the patient not getting rid of the medication.

Acetaminophen does not work for chronic pain anyway. Education is important but people need some way to get pain relief. All these restrictions are making it difficult for people to get pain prescriptions. Do you people to be able yo take care of themselves or do you want people disabled and staying inside laying around because it is not worth the lain to move. Get real people! I denied my pain for a long time. I would drink too much after work because I was hurting. I had 3 different joint replacements and revisions. I am better but still have some pain. I can not do what I use to do. Joint replacements do not stop all the pain. I wish I did not have pain but I take ibuprofen to max dosage despite having GERD.


If chronic pain patients had access to proper pain mangement, they might not over use OTC meds. I know there is a lot of confusion regarding Tylenol use in general. But when that is all someone has access to that is in chronic pain, if the pain is severe enough they will take what they have to in order to get some relief.

Diane Succio

Are you kidding me. The government should worry about the deficits and get their act together. I go to Pain Management for the Dr to manage my pain not the Government. No wonder we are failing as a nation. I am scorned upon from my pharmacy looked down upon by Family yet not one person will walk in my shoes for 5 minutes. Get a grip people before you can’t by anything OTC.

Donna M. Harker

Okay I just have to say this why am I not surprised that the FDA who has approved aspartame and asuflame and olleo aka margarine all known toxins and if used according to package use will kill you. So they first take painkillers away ,in my state chronic pain patients are being told by their doctors “you have a chronic pain disease so you’re chronic pain patients going to have pain you better get use to it ” because in my state, its now illegal for your doctor to prescribe pain medicine to chronic pain patients.Now to make things even less bearable they are now going to make Tylenol have to be prescribed because they have a fear of what people may do in the future so they are punishing everyone who suffers from any pain because someone may use it to commit suicide hey just keep backing us into a corner with no where to turn for any relief from our pain and 1 of 2 things will happen either someone will finally lose it and give them the type of pain we suffer with or there will be another “Boston tea party” type deal because the Government has cut anything and everything that could possibly help some of us get by to live another day.The lack of compassion and the willingness of the government today to throw out “certain” Americans is disgusting and proves this is no longer something to help anyone. All it will do is increase the cost of Tylenol and all products that contain it’s main ingredient ,acetaminophen , so the rich get richer and the disabled gets left out in the cold with nowhere to turn