FDA Looks To Enact Tighter Restrictions On Vicodin
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11-26-13 Category: Addiction Treatment, Drug Rehab

Vicodin is one of the most widely abused drugs in the United States. People are hooked on this drug that will either create permanent damage or will kill them. In 2010, Vicodin was the most prescribed pharmaceutical drug in the U.S. with 131 million prescriptions filled. The Food and Drug Administration (FDA) has submitted recommendations to the Drug Enforcement Administration (DEA) to change the way Vicodin is classified.

Drug Organization

Five drug classifications exist for all controlled substances: Schedule I, II, III, IV, and V. As the number ascends, the risk of the drugs in that category decrease. In other words, a drug that falls into Schedule I is much more dangerous for human use than a drug that falls into Schedule V. The drug schedules dictate how a doctor goes about prescribing medications, how drugs are dispersed, and what legal restrictions and penalties are in place when someone abuses a prescribed drug like Vicodin.


Composed of hydrocodone and acetaminophen, which you may recognize as the main ingredient in Tylenol, Vicodin is currently classified as a Schedule III substance. As outlined on the DEA’s website, www.justice.gov/dea, drugs, substances, and chemicals in this category are considered to have a low to moderate risk of addiction, defined as physical and psychological dependence.

In addition to Vicodin, other current Schedule III substances include: all drugs that contain less than 15 milligrams of hydrocodone per dosage unit and all drugs that contain less than 90 milligrams of codeine, plus ketamine, anabolic steroids, and testosterone. Schedule III drugs are not considered as dangerous as Schedule II drugs, which include cocaine, methamphetamine (crystal meth and other versions), methadone, hydromorphone (used in Dilaudid), meperidine (used in Demerol), oxycodone (used in OxyContin and Percocet), fentanyl, Dexedrine, Adderall, and Ritalin. The current drug classification of Vicodin does not show its comparable dangers to drugs like OxyContin and Adderall.

The FDA’s Proposed Changes

  1. The Food and Drug Administration is finally recognizing the true danger of Vicodin by recommending that the DEA change the classification of Vicodin from Schedule III to Schedule II.
  2. What will actually change the most is the way doctors can prescribe Vicodin, and the way users can access the drug. Physicians, who believe that a certain patient is experiencing pain that requires an opiate painkiller like Vicodin, will only be able to write a prescription for 90 days at most. This change, from a current possible 180 day prescription, will limit access to those who are abusing the drug.
  3. Further, after the 90-day supply, instead of being able to call in a refill, the prescribing doctor must meet with the patient who is taking Vicodin for an in-person evaluation. If the doctor then feels that another 90-day supply is appropriate, only then will a patient get another formal written prescription for Vicodin.

How the Process Works

A statement issued by the FDA states that, “We anticipate that the National Institute on Drug Abuse 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 FDA is scheduled to submit its recommended changes to the Department of Health and Human Services (HHS) in early December, and then the DEA then makes the formal changes. The whole process can take up to a year to be completely finalized, but comes quickly when compared to how long various experts have been working for the schedule change.

Response to the FDA’s Tighter Restrictions on Vicodin

Andrew Kolodny, MD says, “I’m thrilled by this news,” but he goes onto say that it is “bittersweet” because thousands of people have become addicted to or have lost their lives to Vicodin just since talk of the reclassification began. Dr. Donald Teater, M.D. told AAFP News Now that, “(The proposed schedule change) is certainly not a magic bullet, but it will make some difference.

In the whole area of prescription drug abuse and overdose, there’s just not going to be one magic solution, but a whole bunch of small steps like this. I think we need to be pleased with every positive step and keep going forward.”

Vicodin Addiction Needs Treatment

If you, or someone you know, has been abusing Vicodin or another prescription drug, formal treatment is needed. Addiction will only get worse when left untreated. By calling Sovereign Health Group of California, you can begin to heal and to start your road to recovery from harmful drugs and dangerous lifestyle choices. Call (866) 819-0427 now!

Blog Post By: Jared Friedman

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