FDA Panel Wants Tighter Control over Pain Pills

A US Food and Drug Administration advisory panel voted last Friday to recommend that popular pain relievers containing the opioid hydrocodone be moved from Schedule III to Schedule II of the Controlled Substances Act. Popular prescription drugs containing hydrocodone include Vicodin and Lortab.

That would put Lortab and Vicodin in the same schedule as morphine and Oyxcontin, which contains oxycodone.

If the FDA agrees with its advisory panel and reschedules hydrocodone, pain patients using the drug will have to go the doctor's office to get prescriptions written twice as frequently as now. Schedule III drugs can be prescribed for up to six months at a time, while Schedule II drugs can only be prescribed for three months without another visit to the doctor.

The FDA has for years resisted efforts to tighten controls over hydrocodone, saying it could limit patients' access to pain medicine, but as overdose deaths and addiction rates from prescription pain relievers have jumped in recent years, pressure has been mounting on the agency. The agency is acting now after receiving a request from the DEA to consider rescheduling.

The advisory panel's 19-10 vote received mixed reviews from experts consulted by the Milwaukee Journal-Sentinel.

Andrew Kolodny, a psychiatrist and addiction specialist who heads Physicians for Responsible Opiate Prescribing lauded the vote, saying it will lead to fewer people getting addicted to opiates.

"Doctors have had a false sense of security (about prescribing the drugs)," said Kolodny. "This is a clear message that hydrocodone is addictive," he told the Wisconsin newspaper.

"It seemed pretty clear to me that the preponderance of the evidence supported rescheduling," said Peter Kaboli, associate professor at the University of Iowa Carver College of Medicine.

But Jan Chambers, president of the National Fibromyalgia and Chronic Pain Association, said she voted against the proposal because she has heard so much from family members of people who have committed suicide because they are in such pain.

"Millions of people don't have access to the pain specialist or the doctors who can prescribe these Schedule III drugs," she said.

And Lynn Webster, president-elect of the American Academy of Pain Medicine, said putting tighter controls on hydrocodone will reduce prescribing and abuse, but worried about the impact on pain patients.

"I hope chronic pain patients and acute pain patients don't suffer as a result," said Webster, who spoke at the panel hearing but was not a panel member.

The FDA has not said when it will make a final decision on the issue. Now, the FDA and the National Institutes of Health must make a recommendation to the assistant secretary for health, who will make a final recommendation to the DEA.

Washington, DC
United States
Permission to Reprint: This article is licensed under a modified Creative Commons Attribution license.
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Out of Control

The FDA and DEA are out of control... someone needs to reign these dogs in and put them in the kennel where they belong.

Spread the word

Write your government representatives and tv and radio, yahoo and other online news mediums. Post messages on their blogs even if it's off subject. We need to be a thorn in the side of America that won't be silenced.

right on

hell yea uncle bob

Brings whole new meaning

To World of Pain...

Control over Pain Pills

The American people voted for a big government president then can't believe it when they are directly impacted by more and more regulations and intrusions into our everyday lives. Don't be surprised if the people who are   legitlegitimatlyinimatley lneedmoflmedicationlegitimatelylegitimately in need of Opioid pain medication are stigmatized by society and their doctors as drug addicts and start having to buy their pain relief on the street because their doctors are too threatened by the government to uphold the Hippocratic oath they took when becoming a doctor.

The people on this planet managed quite well before there were these tyrannical drug laws which began under the Progressive, Woodrow Wilson Administration with the Harrison act in 1914 along with prohibition. Great idea... It worked out great for organized crime back in the 20's and it's achieving the same now.

 All the injustices and wrongs in the world can be tied directly to government and religion. Well intentioned people who think they are smarter than the average citizen. The road to Hell is paved with god intentions and unintended consequences.

Please Mr. Politician save us from ourselves!!!!!

DEA wants pain patients to buy on street

The DEA wants pain patients to have to buy on the street. By doing it that way they can seize patients property. This helps them because half the time people are not given receipts for cash taken and they can keep what they want. In Florida it is harder.to get a pharmacy to fill your presciption for schedual II narcotics. The only thing they will fill is schedual III. If they become schedual II pain patients will have nothing. I dont know how many patients will turn to the streets but I do know we have had enough suicides down here already by telling a patient who has been on oxycodone for years that they can only get vicodin now. The pain is so bad you do consider taking your like and down here a few older adults have.
LEAP_Speaker's picture

It's NOT the Opioids in Vicodin that Will Kill You

If the FDA had anyone who knew anything about drugs, they would know it's NOT the Opioids in Vicodin that kill people, it's the Tylenol that will kill you.... So what's the bad drug here?


Jay Fleming

LEAP Speaker 

Unfortunately, the Vicodin

Unfortunately, the Vicodin family has two problems...the Tylenol is what kills your liver, you are correct.  The hydrocodone, however, is the addictive substance that gets you hooked.  People get addicted to these medicines so easily it's ridiculous, and often it starts out as a legitimate reason. But then they get hooked on them (hydrocodone) and start taking more and more due to increased tolerance, leading to liver toxicity (Tylenol). So, in essence, it's the combination of the two components that makes the one medicine so potentially deadly.

Hugh Yonn's picture

The FDA and DEA are the last to be trusted.

Several years ago, I had surgery on my right shoulder.  Pain medication was prescribed..."take one capsule every 4 hours."

I took one capsule. 

I was down for over 20 hours.  When I came to, I felt like I had been hit by a truck.  The next time I felt discomfort, I smoked a small amount of marijuana...pain gone, no after effects.

I threw the pills out.

Then I wrote:  Shoulda Robbed a Bank

I spent 5 years in Federal Prison for the marijuana smuggling adventures described in this book.  I admit, I had a great time.  No one was injured, no one was killed, firearms were not involved.  There were no victims.

We were Americans...doing what Americans do best...living free.

I would be honored by your review.

I have not taken [email protected]$%#^&#@^*(^$#$%$$$$$$$$$$$

I am absolutely devastated.  I am 56, trying to make it to 57 years old.  The other day, after 2 years with the same pain management doctor, and sticking to the doctors order, I was called in to the office because heroin was found in "my" urine.  After being in complete shock, and having my medication cut in half, it occurred to me that I had not given a specimen  at the visit in question.  Perhaps it was ordered that day but not told to me.  Perhaps the label was initiated and placed on another patient's specimen.  Regardless, the screen was "positive for heroin" and the question of my having taken it remains on my record.  Who can successfully dispute a drug screen and have it removed from their history?  I promise you to the end of my days that I have not taken heroin, yet can you  comprehend the medical ramifications alone that I will now incur as a result of this incident and regardless of my sincerity?

I  just completed 5 grueling months of IV antibiotic therapy.  I have struggled with Lyme disease for some 20 years.  Finally, I am seeing light at the end of the tunnel, to my great surprise.  I am feeling better, ready to step down (gradually) from medications and actually began doing so.  I am preparing to have a much needed surgery that I put off for years due to the effects of Lyme.  I really wanted to discuss these things, but instead I am faced with this nightmare.  I still cannot believe it.  This is horrible.  There is no one watching these technicians, no second checks on the names going on to the vials of urine, and yet our very lives are at stake.  And believe me, I may never be privy to appropriate treatment for pain to the end of my days because of that issue.

America, home of the free has changed, and if something isn't done about these regulations at whim, then we are going to find ourselves in a heartless America where compassion is scoffed at.  As a victim of this current attitude I believe we are passed the point of no return.  How do you think Nazism began?  Do you think it happened overnight?  It took years to develop, and millions of people died-LOST THEIR LIVES-because not enough people had the foresight, compassion, and guts to step forward.  Eventually those who did were shot for doing so. It took WWII to stop it. And note:  Hitler was an abused child.  Documentaries tell us that he was beaten to unconsciousness by his own father, and as a former psychiatric nurse I can assure you that emotional abuse can be just as crippling. So, isn't the answer prevention...education...compassion?  

I have always felt that a war should never be called upon its own people, so I am against the drug war.  I believe in treatment when it comes to such intricate issues as addiction to drugs, because most certainly putting someone in jail is like bringing the fox to the chicken coop.  But know the difference in addiction and medical intervention for the treatment of pain, and in any case, compassion, compassion, compassion.  PLEASE, please know that this can happen to YOU and it can happen to your children because the drug war is not a war on drugs...it is a war on the people who do them whether you are legitimate or not.


Pain patients guard their medication because they depend on it, most like myself keep it locked in a safe. People like you are the reason I spent 8 years in agonizing pain and was on the verge of suicide! We need our unfettered access to pain medication and not your lies about school kids, GOT IT?


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