FDA Wants Tighter Controls on Hydrocodone

FDA Wants Tighter Controls on Hydrocodone

The U.S. Food and Drug Administration is planning tighter restrictions on drugs that contain hydrocodone, an opioid widely used in potentially addictive pain medications such as Vicodin.

Hydrocodonebtibu75200-300x224Hydrocodone products are currently classified as Schedule III controlled substances. Under the FDA plan they would be reclassified as Schedule II products, making them harder to obtain for both addicts and legitimate pain patients.

The agency said it would submit a plan for rescheduling later this year to the Department of Health and Human Services (HHS) and the Drug Enforcement Agency (DEA).

“In recent years, the FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States,” FDA commissioner Janet Woodcock said in a statement.

“By early December, FDA plans to submit our formal recommendation package to HHS to reclassify hydrocodone combination products into Schedule II.  We anticipate that the National Institute on Drug Abuse (NIDA) will concur with our recommendation. This will begin a process that will lead to a final decision by the DEA on the appropriate scheduling of these products.”

The rescheduling would affect dozens of pain medications that contain hydrocodone, including Vicodin, Lortab and Norco. A complete list is available here. Typically in these products, the hydrocodone is combined with either aspirin or acetaminophen.

“While the value of and access to these drugs has been a consistent source of public debate, the FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse,” Woodcock said.

Patients must present a written prescription to the pharmacist for a Schedule II drug and physicians are not allowed to call in a prescription to the pharmacy.  Schedule II drugs are limited to a 90-day supply, after which patients must visit their doctor to get a new written prescription. Pharmacists are not allowed to change the dosage, formulation or quantity prescribed of Schedule II drugs.

In January, an FDA advisory panel voted 19 to 10 to reclassify hydrocodone products. The FDA usually follows the recommendations of its advisory panels.

A bipartisan group of lawmakers has also been urging the FDA to reclassify hydrocodone.

“Rescheduling hydrocodone from a Schedule III to a Schedule II drug will help prevent these highly addictive drugs from getting into the wrong hands and devastating families and communities,” said Sen. Joe Manchin of West Virginia.

“I am also extremely grateful that the Food and Drug Administration has finally implemented its own advisory committee’s recommendations to reclassify these addictive drugs. The agency has just saved hundreds of thousands of lives.”

Hydrocodone is the most widely prescribed drug in the U.S.  Over 130 million prescriptions were filled for Vicodin alone in 2010.

Overdoses from painkillers such as hydrocodone now take the lives of more than 15,000 Americans each year, more than heroin and cocaine combined.

Authored by: Pat Anson, Editor

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There is a multi-layered problem when government gets involved with medicine. As someone who has been through the heath care system b/c of chronic pain, I can tell you it’s not a picnic. I have a problem with them regulating certain medication, but if it’s insisted upon, then they better get involved with the entire health care protocol. They want to cut off meds that are sometimes a last resort for some, but have no alternative solutions for therapy. What meds do they have for substitution? Think too many people are on these meds? Start regulating insurance companies that drag out testing they don’t want to pay for, like an mri, so that an injury isn’t left unidentified for over 6 months. Maybe physical therapy would have worked if started immediately. In my case, the injury was left for 1 year before ANY therapy was tried. I hear stories of Dr’s handing these pills out, though I’ve never experienced that, I believe it. Don’t forget though, that a lot of people also stole these medications from others. The mistake was not telling pts to hide & destroy pills. I know this now from experience, but it took my pills being taken to realize. Pmetzler - I appreciate your thought coming from the view of someone who lost a loved one, but it isn’t as simple as go get your script more frequently. I lost jobs over too many appointments. I pay $50 every time I am seen. Nothing changed, I’ve been the same for 3 yrs. I can’t go to a different pharmacy for ANY meds, even if it’s cheaper elsewhere or they run out. I also can’t fill medications early AT ALL, so I have to wait till the day they are due, you know the day I’m suppose to take it. They don’t care about the fact I need it when I wake up not at 1pm. Guess what? The pills are still out there. Instead of$5 they make $10. We’ve only raised the price on the street, and the stakes to get them. With the new regulations I still know 3 people I could call if I wanted to get pills. I have to ask… Where did your son get his meds from? If it was a Dr then you should make them responsible, if not he stole them. Even if he bought them, they were either stolen or prescribed to someone who choose to lie Just because someone sells something, doesn’t make it okay to ingest. There are cracked dealers, only those who seek it out find them. Regulation is only a partial solution. No individual is to blame. It’s as simple as getting society involved to better a community. Parents, teachers, & adults watch your kids for early signs of addiction. Dr’s talk to your pts. Government fix the broken health care system! Can’t fix the roof on your house if the foundation is crumbling. We have created a new problem of chronic pain pts… Read more »

Rebecca Langston-Travis

its just another way FDA supports big pharm restricting acess to something we report helps. ive been diagnosed over 20 years sick for 18 with hydrocodone ive gone to work at a high functioning career with the federal government raised 4 kids and had a life everytme i encounter issues such as being removed because doc insisted i try gabapentins, ive come close to dying. because they want to push cymbalta lyrica savela for big pharm, they don’t listen to what works. they keep saying opiods don’t work. they must not be talking to the thousands of fibro warriors on all these support sites. we aren’t drug seekers. to the lady whose son overdosed. im sorry for your loss but addicts are gonna find what they need regardless . i can get it off the street easier than from pharmacy but as a rsponsible person, i dont. dont blame the medicine blae whatever led ur son to hide behind drugs. i shouldnt have to spend my life in screaming pain so bad i want to die because your son couldnt handle life and took meds in ways not intended. im sick of being treated lie a druggie because of the druggies and being denied healthcare for it


I have suffered with fibromyalgia since I was about 23, I am now 42, I started on vicodin because I was taking WAY over the amount of tylenol, and ibuprofen and damaging my stomach and liver, my doctor put me on 3 vicodin a day, 5 yrs. ago, during that time i was introduce to cymbalta when it came out which i started to feel less pain, so i told the doctor i’d like to try to go down to 2 vicodin a day, I am the one to took the responsibility to go down, not my doctor, i have tried everything and nothing has helped the the vicodin, and now that people are abusing it, we suffer because we can’t find a doctor who will give it to us, i have been on a program called MAPS it is not in the state i live in now but in Michigan where I did live, what it does is help doctors regulate you in a manner of drug testing and close monitoring along with signing a contract not to use any other form of drugs beside what is being prescribed, why don’t the government make it where it is obtainable for the people who need it, if u need that medication like i do then make our doctors go through more training to know what to do to trust the people who are not abusing it, there is also a system in which drug seekers are flaged in a computer system and make it harder for them or impossible to only the people found to have abused it,stop taking everything out on everyone in pain it’s cruel, inhuman,unfair, and if this medication is the FDA’s plan to make it tougher then they might as well take it totally off the market because, if your going to pick and choose who gets it or not, then what chance do the real suffers have? why are people going to school to be doctors if they are not going to help there paitients, I’m sick of hearing that fibromyalgia does not work with vicodin, well then why are so many fibro paitents saying it helps, my doc keeps saying statics show it don’t help, well who are our statics, are they pain suffer’s, are they normal people, are they fibro paitients? who are they, what works for one person may not work for another, who is got the right to make that decison about what works for me, and you?


Before I begin, this is coming from someone with chronic pain. I have small fiber fibromyalgia, which causes very bad pain in my lower body. My daily is usually a 6 or 7 out of 10. In the winter, I’m an 8.

The reason this is going to make life more difficult for pain patients, is that less and less doctors will be willing to deal with chronic pain patients. On top of that, it could take a patient years to even get a diagnosis. It took me over 6 years and, many, many doctor visits. I had many who just did not understand how pain medicine interacts with chronic pain patients.

On the other hand, calling for prescriptions is almost a way of life for a chronic pain sufferer. I have to call every 30 days to get an MS Contin prescription. It is something I can’t function normally without. I’m just about bed ridden from pain if I’m not on it. During the winter months, I have to add Lortab with that. Usually just once a day. If I’m calling in for morphine already, it isn’t that big of a deal for me to call in for the Lortab also. I’m not abusing it, I’m not selling it and I don’t give it to anyone else. A true chronic pain sufferer can’t afford to do so, as without it, we can’t function in a semi normal fashion.

Again, it comes down to doctor comfort. Less and less doctors want to deal with the prescribing, and “treatment”, of chronic pain sufferers. We just don’t know enough about what causes these chronic pain diseases. What few seem to realize is that we don’t want to be on these meds. I hate taking medication at all. However, I’m chained to it. As are most any other chronic pain sufferer. That is, until we figure out why they are caused. As well as how to properly treat the pain symptoms.


Finally!! Why would this make it harder for people who need them? You just have to see the doctor and get a script . My son along with thousands and thousands of people have died from these drugs because they are so available , there is no problem getting them if you are addicted. The people who had and still have these medications are not taking them along with the people who will use any excuse to get them for their own addiction are the people who have brought this epidemic to tighter restrictions.

Losing someone you love to this probelm is not when you finally do something about it ==this regulation will prevent the horrible abuse of these pain medications and help save many many lives .

Sheryl Johnson

I think all this just makes it harder for people who really need pain meds.