Acetaminophen: Educate, Do Not Regulate

Target:

U.S. Food and Drug Administration

Sponsored by:

The U.S. Food and Drug Administration (FDA) is considering advice from its Advisory Committee that would eliminate all prescription acetaminophen combination medications (like Vicodin, Percocet) and take the 500 mg (extra strength) dose of acetaminophen (the medicine in Tylenol) off store shelves and make it available only by prescription. These changes could negatively affect people suffering from pain who rely on these medicines every day. The FDA must consider all comments received by September 30, 2009 that are submitted to the official docket for this decision. Please sign the petition letter by September 27, 2009 and the American Pain Foundation will submit the petition to the FDA.

(Submitted to docket number: FDA-2009-N-0138)

We the undersigned are expressing our concern regarding the recent recommendations of the FDA Advisory Committee reviewing the safety of acetaminophen. When used as recommended, acetaminophen is a safe and effective pain reliever and fever reducer and has been used by millions of Americans for decades. This medicine, like all medicines, has risks when used beyond the recommended amounts.

Three factors contribute to the mistaken overuse of this medicine: 1) The risks of over use of this medicine have not been adequately explained to the public. Very few people know the risks associated with this commonly used medicine, 2) The labeling for this medicine is inadequate since on many medicine labels it is referred to as APAP which most people do not understand as a reference to acetaminophen. This mis-labeling results in people not being aware that they are over-using this medicine, and 3) Acetaminophen is a second ingredient in many medicines and is often overlooked by consumers reading labels.

Before taking these medicines away, we urge the FDA: 1) to conduct a sustained public information campaign about the safe use and risks of acetaminophen and 2) improve labeling on all products that contain acetaminophen.

Removing these medicines will negatively affect millions of people who safely use and rely on them every day. These people will be driven to alternatives which may be less effective and have more risks. Educate, do not regulate.

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The Acetaminophen - Educate, Do Not Regulate petition is now closed. We thank everyone who supported this position with their signatures and powerful comments. We will be submitting the petition to the Food and Drug Administration on September 30, 2009.

THANK YOU for all you are doing to improve pain care! We could not have done this without YOU.

Together, as we have done with this petition, our collective voices will make a difference!

Sincerely,
American Pain Foundation

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We signed the "Acetaminophen: Educate, Do Not Regulate" petition!

# 3,255:

4:23 am PDT, Sep 28, Name not displayed, Mississippi
I need these types of pain meds due to IC, DDD and.fibromyalgia. I have allergies to certain pain medications therefore I am limited to what I can take.

# 3,254:

11:37 pm PDT, Sep 27, Carmen Mitsuyasu-Gapero, Hawaii
Please do not remove medications such as Endocet from the market because of the some who are not acting responsibly. I've finally found a pain regimen after many years of trial & error that works for me and allows me to function on a daily basis. Please don't make the mistake of removing these medications that will seriously the vast majority of us pain sufferers.

# 3,253:

11:29 pm PDT, Sep 27, Christina Durstock, Kentucky
Stop punishing everyone for the stupidity of the few. I use all medications, over the counter or otherwise, in a responsible manner and I, and those like me, should not be made to suffer because some people don't. Educate, don't regulate. As one of the MANY uninsured Americans, I find it irresponsible and cruel for the government to even be considering removing the availability of needed medications from the very persons who need it most. Educate, don't regulate.

# 3,252:

9:32 pm PDT, Sep 27, Virginia Burns, Georgia

# 3,251:

9:19 pm PDT, Sep 27, Name not displayed, Michigan
As a Reflex Sympathetic Dystrophy patient, I take Tylenol with codeine in order to be able to function at all. I resent that needed medication is made difficult or impossible to get because of the foolish, self-destructive behaviors of some people. Please find another way to protect those people who refuse to follow medication instructions and allow chronic pain patients the drugs they need.

# 3,250:

8:18 pm PDT, Sep 27, Name not displayed, Rhode Island

# 3,249:

7:26 pm PDT, Sep 27, Susanne Nielsen, Idaho
People who are suffering deserve to be treated with respect. Don't take what relief they CAN find away from them.

# 3,248:

6:58 pm PDT, Sep 27, Name not displayed, Colorado

# 3,247:

5:36 pm PDT, Sep 27, Name not displayed, California

# 3,246:

5:00 pm PDT, Sep 27, Katie Sherman Sherman, Maryland

# 3,245:

4:11 pm PDT, Sep 27, Yvonne Spoon, Florida
I beg you not to regulate these pain meds. I am just barely getting enough vicoden now to control my pain. But those of us to have pain really do need something so we can have somewhat of a life. I have been without pain meds and I had rather been dead than to live like that. So please don't take that away.Unless you walk in our shoes you cannot understand completely. But please have mercy on us who need something for pain to live some what normal life..

# 3,244:

3:53 pm PDT, Sep 27, David Karber, Arizona
THIS IS UNFAIR TO US POOR FOLKS !

# 3,243:

3:46 pm PDT, Sep 27, Kirk Nielsen, Idaho
My daughter relies on these medications to control her cronic pain. It is the only way she can function in society.

# 3,242:

3:28 pm PDT, Sep 27, Sherry Neuman, Oregon

# 3,241:

3:22 pm PDT, Sep 27, Name not displayed, Arizona
My wife suffers from an incurable chronic pain condition and relies on percocet to function normally. I personally have a spinal bulge that is treated with vicodin. If thesee medications are removed from the market, we both suffer even more. We cannot obtain health insurance. We should not have to fight to be treated humanely within the healthcare system. Please do not remove vicodin and percocet. Thank you.

# 3,240:

3:14 pm PDT, Sep 27, Name not displayed, Arizona
I have a chronic, incurable extremely painful auto immune disease. I rely on percocet to function within this world. I currently do not have health insurance, and do not qualify because of my preexisting condition. Please do not remove these medications from the market. Too many of us with my condition kill themselves because of the lack of proper pain management. Do not add to that tally by removing effective medications.

# 3,239:

2:46 pm PDT, Sep 27, Ronda Davis, Georgia

# 3,238:

2:45 pm PDT, Sep 27, Alberta Householder, Florida

# 3,237:

2:40 pm PDT, Sep 27, Kellie Stone, Indiana

# 3,236:

2:37 pm PDT, Sep 27, Maria Alberino, New York

# 3,235:

2:18 pm PDT, Sep 27, George Wahle, Illinois

# 3,234:

2:06 pm PDT, Sep 27, Name not displayed, Texas

# 3,233:

1:21 pm PDT, Sep 27, Janet Davenport, Idaho

# 3,232:

12:27 pm PDT, Sep 27, Name not displayed, California
Educate - don't take away proven effective medicine for those who have the need for and use it responsibly.

# 3,231:

12:10 pm PDT, Sep 27, Celeste Cooper, Missouri

# 3,230:

12:08 pm PDT, Sep 27, Heather Reece, Georgia
My mother suffers from IC and the only thing that helps her to ease the pain are these meds. PLEASE let her be able to continue to take them

# 3,229:

11:54 am PDT, Sep 27, Timothy Joines, North Carolina

# 3,228:

11:12 am PDT, Sep 27, Brad Clodfelter, Arkansas

# 3,227:

11:02 am PDT, Sep 27, Judith Beadles, California

# 3,226:

10:58 am PDT, Sep 27, Donna Heimbach, Wisconsin

# 3,225:

10:43 am PDT, Sep 27, Name not displayed, Washington

# 3,224:

10:32 am PDT, Sep 27, Kristin Byrne, Connecticut
I have very severe Interstitial Cystitis, Fibromyalgia, IBS and Pelvic Floor Dysfunction. I must have my pain medication in order to get through the day. I am no longer able to work and I am only 27. Without my pain medication I would not be able to function or get out of bed, which I am only able to do for a limited time each day. Please do not pass this through legislation, my quality of life and anyone else who suffers from pain depends on this. Thank you so very much.

# 3,223:

9:55 am PDT, Sep 27, Linda Kitlinski, Pennsylvania
"Pain upsets and destroys the nature of the person who feels it." Sadly, Aristotle's quote from the 3rd century BC remains hauntingly relevant in the 21st century. Anyone who has watched a loved one's face relax from the respite that pain medication can provide understands first-hand the impact of effective pain relief on people's lives. Please reconsider the negative impact your proposed actions will have on patients, their ability to remain functional, and their ability to have a life beyond the confines imposed by their pain.

# 3,222:

7:17 am PDT, Sep 27, Kennon Heard, Colorado

# 3,221:

7:11 am PDT, Sep 27, Terry L Bell Bell, Washington

# 3,220:

6:44 am PDT, Sep 27, Lana Caulfield, Virginia
Do the kind thing and increase access to pain meds, not the other way around. Who knows, one day, you may need pain relief yourself.

# 3,219:

6:08 am PDT, Sep 27, Name not displayed, Texas
A few mistakes by ignorant people have been made with this drug. Hundreds of thousands are helped by it everyday, in part, by its convenience. Don't take that away.

# 3,218:

6:04 am PDT, Sep 27, Name not displayed, New York
I've suffered from a Chronic Pain condition since I was a teenager. Without the aid of pain medications, many containing acetaminophen, I couldn't hold a job. I'm still young and have a long life ahead of me. I don't want to be on social programs my entire life because I can't function well enough to hold down a job, and I know the American public also doesn't want this. Don't take away my ability to work.

# 3,217:

5:50 am PDT, Sep 27, Kacy Kolb, Rhode Island

# 3,216:

5:04 am PDT, Sep 27, Kathleen Puntillo, California

# 3,215:

2:38 am PDT, Sep 27, Barbara Tomlinson, Washington
Why make it more difficult for sufferers to get their needed pain medications? This is unnecessary interference in a very personal thing. The stories here are very touching and painful to even read. Please alleviate suffering; don't increase it. There are already too many bureaucratic hoops to jump thru.

# 3,214:

12:47 am PDT, Sep 27, Rebecca Sinclair, Rhode Island
Have you given ANY thought to those of us in chronic pain??? Just what we need, ANOTHER Rx. Geeze, guys, get your act together!

# 3,213:

8:39 pm PDT, Sep 26, Name not displayed, Washington

# 3,212:

8:19 pm PDT, Sep 26, James Stemple, West Virginia

# 3,211:

7:36 pm PDT, Sep 26, Lisa Ishihara, Minnesota

# 3,210:

5:59 pm PDT, Sep 26, Name not displayed, Virginia
I urge you not to change availability of tylenol and its combination with codene or as in Persoset. For people in pain, this is often the only relief.

# 3,209:

3:52 pm PDT, Sep 26, V. Gowenlock, Oregon

# 3,208:

3:45 pm PDT, Sep 26, Scott Sommers, South Carolina

# 3,207:

3:22 pm PDT, Sep 26, Name not displayed, Washington

# 3,206:

2:44 pm PDT, Sep 26, Name not displayed, Missouri
To maintain a job and manage my family and home I MUST be functional. Even with pain medication I don't function at 100% but without it, I would be a completely non-functional human being. That is not helpful or fair to anyone in my world.

# 3,205:

2:08 pm PDT, Sep 26, Name not displayed, California

# 3,204:

2:00 pm PDT, Sep 26, Elaine Shapiro, Connecticut
This seems to me to be totally crazy. Enough intervention.

# 3,203:

1:50 pm PDT, Sep 26, Kim Holtswarth, Missouri

# 3,202:

1:33 pm PDT, Sep 26, Daryl Ross, Illinois

# 3,201:

1:15 pm PDT, Sep 26, Lorrie Campbell, New Jersey
If you remove these products off of the market you will be affecting the millions of people who use these products to get rid of their pain. Whether it is chronic pain or mild pain better education on the use of these products is a better way to go than the drastic move of taking them off the market. We need better labeling of products of all kinds to let the public know what they are really buying. Things should not be approved until there is long term studies into the effects of these products.

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