FDA Changes Regulation Of Painkillers

by baladmin | October 30, 2013

The Food and Drug Administration (FDA) is working on changing the regulations on prescription narcotic painkillers.

For years pharmaceutically manufactured versions of opiates, created to mimic the effects of heroin, codeine, and morphine, have lead to thousands of premature and preventable deaths.

Without a complete understanding of what these highly-addictive painkillers are really doing to people, prescription opiates quickly became the most frequently prescribed, the most highly sought after, and the most widely abused drugs in the United States.

The U.S. represents 5% of the world’s population, yet is consuming 80% of the world’s pain pills.

The FDA is in charge of regulating how drugs are dispensed by doctors and how they are to be taken by patients.

Drug Categories

All drugs are put into 1 of 5 categories, called Schedules, that are used to decide applicable regulations. The DEA oversees the scheduling and regulation process.

Schedule I Drugs are considered the most dangerous, have a high potential for addiction (which is physical and psychological dependence), and create damage to users’ physical and mental health. These drugs have no medical use and are illegal. Heroin, LSD, marijuana, ecstasy, methaqualone, and peyote are Schedule I drugs.

Schedule II Drugs are still considered high-risk for abuse and physical and psychological dependence, but less than Schedule I drugs. Schedule II drugs are cocaine, methamphetamine, methadone, hydromorphone (Dilaudid), meperidine (Demerol), oxycodone (OxyContin, Percocet), fentanyl, Dexedrine, Adderall, and Ritalin.

Schedule III Drugs are considered to have low to moderate risk of physical and psychological dependence, lower abuse potential than Schedules I and II, and include: a drug with less than 15 milligrams of hydrocodone per dosage unit (Vicodin), a drug with less than 90 milligrams of codeine per dosage unit (Tylenol with codeine), ketamine, anabolic steroids, and testosterone.

Schedule IV Drugs are said to have even less risk than Schedule I, II, and III drugs, with lower potential of abuse and dependence, and are considered medically-effective. Xanax, Soma, Darvon, Darvocet, Valium, Ativan, Talwin, and Ambien are Schedule IV.

Schedule V Drugs, with the lowest potential for abuse or dependence, and used for many medical purposes: diarrhea, cough suppression, and pain relief. Schedule V: a drug with less than 200 milligrams of codeine or per 100 milliliters (Robitussin AC), Lomotil, Motofen, Lyrica, and Parepectolin.


As you can see, Vicodin is considered less dangerous, with lower risk of addiction, than OxyContin because it includes acetaminophen instead of just pure hydrocodone (the opiate component, like oxycodone, that has similar effects as codeine.)

What is not taken into consideration is the physical impact of acetaminophen, mainly liver toxicity and death. The argument for a Schedule III placement for Vicodin, accepted by Congress, sent a message that the drug is not dangerous, and should be prescribed by doctors to patients who express physical pain.

Why Are Dangerous Drugs Still Available?

Prescription pills have become a business, and pharmaceutical companies are finding ways to get addictive products into the marketplace. This is creating an epidemic of opiate addiction.

Money talks, and lobbyists for drug companies are figuring out how to keep their pills categorized as Schedule III substances, making them easily prescribable by doctors and easily refillable by addicted patients.

What Changes Did the FDA Make?

The FDA is proposing a Schedule II listing for Vicodin. The proposal has been submitted to the DEA for approval.

A Schedule II listing would mean that, for drugs that contain hydrocodone, regulations will change to allow a 90-day maximum amount of the drug for one person. To obtain a refill, the person taking the drug must have another official doctor’s appointment with the prescribing physician.

The change the FDA has made on its own is the adjustment of the text on painkiller labels, which will now say “drugs should be used only when alternative treatment options are inadequate”, as opposed to current labels that read, “for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.”

If you, or someone you love, is abusing a prescription painkiller like Vicodin, contact Balboa Horizons for more information!