FDA recommends tightening access to hydrocodone pain-killers

WASHINGTON Fri Oct 25, 2013 7:46am EDT

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012.

Credit: Reuters/Jason Reed

WASHINGTON (Reuters) - The U.S. Food and Drug Administration on Thursday recommended tighter restrictions on products that contain hydrocodone, an opioid painkiller present in commonly prescribed, potentially addictive drugs such as Vicodin.

Until now, Vicodin and other products that contain less than 15 milligrams of hydrocodone have been classified as Schedule III controlled substances. The FDA recommends reclassifying them more restrictively -- potentially as Schedule II products, in line with opioid pain-killers such as oxycodone and morphine.

Reclassifying the products would make them harder to obtain, both by addicts and by legitimate pain patients. Physicians are not allowed to call in a prescription for a Schedule II product to a pharmacy. Instead, patients must present a written prescription.

In addition, patients would not be allowed as many refills before returning to see their doctors, potentially representing a hardship for patients in chronic pain.

The proposed change was urged by the Drug Enforcement Administration, which is battling a rising tide of prescription drug abuse. The change must be approved by the Department of Health and Human Services and the DEA, which will make a final scheduling decision.

Opponents of the rule change, including many physicians, have argued for years that restricting pain products further could cause hardship to pain patients, especially the elderly.

Proponents argue that the death toll from abuse is unacceptably high.

Nearly three of four prescription drug overdoses are caused by opioid pain-killers, according to data from the Centers for Disease Control and Prevention.

Regulators are trying to tackle the problem from a variety of angles. In an attempt to restrict supply, the DEA has been putting pressure on wholesale suppliers of prescription drugs to police their customers better.

Several companies, including Pfizer Inc and Endo Health Solutions, have been working to develop tamper resistant opioids that cannot be easily crushed or dissolved by addicts looking to get a full dose of the drug quickly.

The misuse of prescription pain-killers was responsible for more than 475,000 emergency department visits in 2009, a number that nearly doubled in just five years, according to the CDC.

In January a panel of outside medical experts voted 19 to 10 to reclassify the products. The vote followed two days of discussions.

Dr. Janet Woodcock, director of the FDA's pharmaceuticals division, said in a statement that the agency has, over the past few years, 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."

In the end, she said, the level of opioid abuse and the "tremendous amount of public interest" in the matter led the agency to recommend a change.

(Editing by Dan Grebler)

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Comments (12)
Daniel2912 wrote:
It absolutely amazes me how extremely ignorant the “leaders” in this country are. Do these “leaders” know why SOME people are addicted and die at the hands of prescription painkillers? I guarantee you they don’t, so I’ll tell them. They get addicted because of DEPRESSION. Depression is the underlying cause of ANY addiction. Whether it is shopping, love, drugs, alcohol (which is, in fact a drug, and THE worst one of all), video games, etc. Do you want to know the reason that people overdose and die because of prescription painkillers? ACETAMINOPHEN (usually mixed with alcohol), you know, acetaminophen, the active ingredient in Tylenol that’s EXTREMELY destructive to your liver in HIGH doses. You know, Tylenol, the thing that a lot of doctor’s are going to suggest that you start taking because they’re too scared to prescribe painkillers because the DEA are a bunch of moronic simpletons. They might also suggest you start taking ALEVE or another NSAID. These are also extremely destructive to your internal organs and your stomach, and most aren’t able to tolerate them for more than a few years. So, in fact, the safest ingredient is actually Hydrocodone. Hydrocodone, by itself, harbors almost no destructive consequences. Do you see the irony in this?

If someone is in pain, they’re going to find a way to relieve it one way or another. Sorry, DEA, but there’s nothing you can do about that. If you restrict the painkillers people will then start taking massive doses of Tylenol, and as we all know, Tylenol does absolutely nothing for a person that is truly in pain. So, when the Tylenol doesn’t work, they’re going to start mixing that with alcohol. You know, alcohol, the DRUG that is the most destructive substance known to man, yet is still LEGAL, and always will be. Ironic, isn’t it? Many of these DEA agents still love their liquor, though. They would never think about outlawing that because at the end of a busy day they just need something to take the edge off. Also, they saw how unsuccessful prohibition was. Did you know that law enforcement officers are among the top 5 professions where the workers are alcoholics? The reason being, many are DEPRESSED due to the nature of their job, and they need something to cope. Did you know that law enforcement officers also are in the top 5 professions where their workers commit suicide? Is this starting to all come together for you folks now? Are you starting to see the irony and hypocrisy? Interesting, huh?

Responsible users need these medications, and should NEVER be stigmatized for having a medical condition that requires them having to take Hydrocodone. When used responsibly in small doses they increase the quality of life for all users. Of course, addiction is horrific, and people with DEPRESSION are way more susceptible to becoming addicted to Hydrocodone. That’s why simple monitoring and adherence to doctor recommended dosage (WHICH WE ALREADY HAVE) is great, and it works. I’m sorry, but the people that are depressed need to seek out help from a psychologist, friend, family member, and get the help they need to resolve the underlying issue for their depression and addiction. Family members also need to try and look for the warning signs of an ADDICT, not a responsible user who has a medical condition. Also, the solution for someone that is depressed is NOT to take psychotropic antidepressant drugs!!!!! These drugs are the most dangerous and addictive of all!!! These drugs are more than 50 times more addictive than painkillers and they solve none of the problems that people who suffer from depression have. They alter the serotonin system in the brain in horrible ways, lead to extreme risk taking and destructive behavior, and these drugs are the very reason why many people in society have changed for the worse. Almost all of these mass murdering kids have been on some type of antidepressant drug while they were committing their heinous crimes. Antidepressants should be at the forefront of drug reform, NOT Hydrocodone.

Oct 25, 2013 7:42am EDT  --  Report as abuse
GrimmTale wrote:
Once again, because of people who cannot govern THEMSELVES, we enlist the federal government to do it for us! This article, and the FDA’s resolutions for these opiate based drugs are so incredibly biased, and are not telling the entire story. To force restrictions onto Dr’s and pharmacies to do the dirty-work for the FDA (which is reeeeaallly the USgovt) is over-reaching and controlling. This is the same as cigarette/tobacco restrictions….all done because the humans of the world can’t think for themselves! GAWD….I’ve had it with this govt dictating what I can/cannot use to alleviate my pain, or what I can/cannot use in general!

Oct 25, 2013 7:53am EDT  --  Report as abuse
Fillybuster wrote:
So we are going to punish legitimate pain sufferers because government is too biased to treat those who would abuse the drugs. The DEA wants more power in more peoples’ lives. What actual help would the DEA provide?

Oct 25, 2013 8:11am EDT  --  Report as abuse
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