FDA panel votes for more restrictions on Vicodin

WASHINGTONFederal health advisors want new restrictions on hydrocodone, the highly addictive ingredient found in Vicodin and other widely abused prescription painkillers.

The Food and Drug Administration's panel of drug safety specialists voted to subject hydrocodone drugs to the same restrictions as narcotics like oxycodone and morphine.

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Headlines: Vicodin may face tighter controls

The panel voted 19-10 in favor of the move, which is supported by the Drug Enforcement Agency. The FDA will weigh the vote in its decision-making process.

Hydrocodone is sold in combination pills like Vicodin, which mixes the drug with non-addictive painkillers like acetaminophen. The drug belongs to a family of drugs known as opioids, which include morphine, heroin, oxycodone, codeine and methadone.

Doctors prescribe the medicines to treat pain from injuries, surgery, arthritis and other ailments such as coughs.

Hydrocodone consistently ranks as the first or second most-abused medicine in the U.S. each year, according to the Drug Enforcement Agency.

Panelists who voted for new restrictions said it would send a signal to doctors about the potential dangers of hydrocodone drugs.

"I don't think reclassification is a panacea for the opioid abuse problem in this country, but I think it's an important step to get doctors to rethink their prescribing practices," said Mary Ellen Olbrisch, a professor at Virginia Commonwealth University.

The DEA has asked the FDA to reclassify hydrocodone as a schedule II drug, limiting which kinds of medical professionals can write a prescription and how many times it can be refilled. The Controlled Substances Act, passed in 1970, put hydrocodone combination drugs in the schedule III class, which is subject to fewer controls.

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An April, 2012 Drug Enforcement Administration report showed that 42 tons of pure hydrocodone were prescribed across U.S. pharmacies in 2010, enough to give 24 5-milligram Vicodins to every person in the United States.

In 2011, U.S. doctors wrote more than 131 million prescriptions for hydrocodone, making it the most prescribed drug in the country.

Currently a prescription for hydrocodone-containing Vicodin can be refilled five times before the patient has to see a physician again. If the drug is reclassified patients could only receive a single 90-day prescription, similar to oxycodone. The drug could also not be prescribed by nurses and physician assistants.

Panelists who voted against the classification change said it would have unintended consequences, driving addicted patients to obtain the drugs illegally.

"If prescribing decreases, illicit opioid use will increase, with dire consequences," said Dr. John Mendelson, of St. Luke's Hospital in San Francisco. "I think this is a mistake and we will be back here with other problems."

Several physician and pharmacist groups also argued that new restrictions would burden medical professionals and disrupt patient care.

"Rescheduling the products to Schedule II would create significant hardships for all - leading to delayed access for vulnerable patients with legitimate chronic pain," said the National Community Pharmacists Association, in a statement.

The FDA is not required to follow the advice of its expert panelists, though their input is often critical in its decisions.

FDA officials closed the meeting by acknowledging the difficulty of combating hydrocodone abuse, while keeping the drugs available for patients who legitimately need them.

"There is an unquestioned epidemic of opioid abuse, overdose and death in this country, an epidemic we need to address as a society," said Douglas Throckmorton, FDA's deputy director for regulatory programs.

[IBCycling]

Perhaps more research needs to be conducted on the causes of pain, especially for those over 60 years of age. I started out with a sharp pain in my SI joint. Now I can barely move in the morning. I use Vicodin as a last resort so I can go to work when ALL the other treatments: massage, PT, epidural injections have been ineffective over time.
I believe all physicians need to look at the patient's usage over time then decide. With all the computer information available to AMA, it seems a person's usage could be easily tracked.
If doctors had the latest surgery techniques at hand for back pain, such as noninvasive uses of laser, perhaps fewer people with chronic pain would be need less or no Vidodin.
Remember, it's the doctors who provide Vicodin because they don't know how to help eliminate the pain!

[ltoney1]

As a chronic pain patient with fibromyagia and degernative lower pain issues, who is on SSD and under the care of a reputable doctor who prescribes me 5 different prescritions to help manage my ability to cope and have some quality of life. Would I like to be pain free, yes but dealing with chronic pain is everyday a managing act. To put rescriptions on the limit for vicodin and the FDA/Government to get involved I see it as lack of commpassion for the patient who really requires this presciption and is managing as best they can. I have seen pain management doctors and yes I would like to not rely on Vicodin the rest of my life. But to restrict and then cost me perhaps a doctor visit would put a strain on me financially, as it is it is difficult every month on the cost of the prescribed drugs that is helping me manage and is something between me and my doctor. Where I may have to decide if I can afford another office visit plus my prescriptions and the fact it is hard enough getting myself to the doctors physically as it is getting to the pharmacy. The FDA should look into those doctors who are not legimately prescribing to patients and not penalize those patient who taking pain meds per the doses from credible doctors who are helping their patients manage the chronic pain.

[no1netfan573]

I used to work with a guy that had a messed up back.The hosital didn't want to operate on him because they told him the operations didn't last.He took some form of the drug they are talking about here and he would get bedridden if he didn't get these drugs.I guess he did this medication for twenty years and it got to the point where he would get bad sick for a week out of each month.I see it this way.If he needs the pills let him have them.He is not hurting anyone else and he is for sure helping himself.At least he is still working at 59 years old.Did someone tell you that the FDA was watching your back or something because believe me they are not.

[Steel95]

I think it's great. Addictive Opiates like oxycodone, hydrocodone, dilauded need to given obstacles. The US has a huge opiate problem out there and the # of people benefiting from these narcotics are much less than the thousands of people/familes being hurt

[hypnotoad72]

*sniff*

What will Rush Limbaugh do? (again...)

[tdbasket]

The FDA should not be allowed to make restrictions on medications. They are not the ones seeing the patient and they do not know the patients history. I have been in horrible pain daily for fifteen years. I have to see my doctor every month for my medications. My illnesses and injuries are well documeted, I have been to pain managemet over five times and was made to endure very painful procedures and several surgeries that have not seemed to help. It is already difficult for me to get any pain medication because of the current regulations. I am worried about what I am going to do. Being in pain is not something I chose and I think that my doctor and I know what will help my quality of life. They need to be more concerned about the people who are getting these drugs illegally or using drugs such as meth!

[californiadreaming1]

Yes ... the government cares more about addicts than people in real pain. Lets take that as another step back toward the dark ages. Patients in terrible pain can just sit and suffer at home!

Talk about screwed-up priorities!

[KA77899]

I fully agree that the unintended consequence of this bureaucracy is that honest users and doctors will be carry an additional burden.

I have need for an opiad pain reliever now and then. Hydrocodone for pain and codeine cough syrup when I get a bad cough.

If a bug settles in my chest, I literally get beaten up from the inside out by the severity of the cough. 2-3 days of the cough syrup does 2 things. I stop "coughing up a lung" (much to the relief of anyone in my vicinity) and it "resets" that cough reflex and it goes away. Just waiting for the bug to get beaten back by my immune system, doesn't work. I've tried it - believe me. Making me and my doctor jump through hoops is just plain stupid and wrong.

I get the bad cold/cough every 1-2 years. My doctor phoned in a prescription for the cough syrup for me last Spring. 2 days later, cough was gone and I still have syrup in the bottle. My doctor knows that this happens. Why aren't we trustworthy? I thought innocent until proven guilty!

We are lucky here because our medical system has gone to electronic records. Even medicine refills have to be requested by the pharmacy, not the patient. If the doctor has to give me a printed prescription, due to the class the medicine falls under (I.e. hydrocodone), he prints it out. There is no prescription pad for someone to steal.

In fact, the paper script is a less secure way to handle these drugs. If they can be faxed directly to the pharmacy, they can't be "sold" stolen, etc. This requirement is just putting an added burden on the doctor and the patient in the hopes it's too much of a hassle to be bothered with.

My doctor is located about 25 minutes from me. I travel that distance because he is an exceptional doctor. I really don't want to waste time and gas, etc. to pick up a paper prescription. I saw him last week and he talked with me about the dangers of opiads. I also had to read and sign paperwork and answer a comprehensive survey. The education is happening. No need for more laws.

One of the things I agreed to is the fact that I won't be able to get a replacement prescription earlier than it is time for it. No excuses. I have no problem with that. I use them sparingly and only when I have a lot of pain. I always go way longer than the point at which I could ask for a new script.

Our system is robust. Stop trying to overburden honest patients and their doctors. Go after the addicts! Put bandit barriers in pharmacies, or whatever. No more hoops to jump through for people and doctors who are just trying to manage pain.

[bar22mike]

The DEA's prescription for chronic pain sufferers is regressing to:

Bite on a stick and/or hold on tight.

[tdbasket]

I agree with you. My aunt has severe rheumatory arthitis and has difficulty going to the doctor. Most days she can barely stand and cannot drive herself. They have also reduced the number of pain pills she is allowed and she has to visit the doctor more often which is also a financial burden. Thanks FDA, I guess I will go gather her some sticks.

[djseavy]

As a chronic pain patient who relies on fentanyl patches and morphine for breakthrough pain, I'm very familiar with the nuances of the FDA and DEA. First, the DEA loves to control doctors who genuinely care about their patients. The doctor goes to school for at least 8 years to practice safe and effective medicine. The average DEA hack might have a 4 year degree in business management. Which would you rather have deciding your medical care? Furthermore, very little addiction is derived from legally prescribed Vicodin. Properly monitored, narcotic and barbiturate painkillers are safe and few patients become addicted. It's the theft from pharmacies; doctor shoppers who seek out several scripts; underground activity, etc. that causes the problems. But since the DEA hasn't been successful in its war on drugs, it has to go after the doctors and give the appearance that the agency is actually doing something positive. They should quit trying to practice medicine.