New FDA approved Painkiller More Addictive?

When my son had his knee replacement at age 49, I stayed to help during the rehab .My son is a line foreman for the local utility company. He has spent the last 25 years climbing poles and in and out of the bucket truck, hence the need for a knee replacement. His knee joint was non-existent. In the first couple of days after the surgery while he was still admitted to the hospital his pain management was through a catheter inserted into his knee. He was very comfortable. When that finished and he was transitioned over to an oral medication, we were discharged to home. That’s when the fun started.

My son is over 6 feet tall, 250 lbs, and not a weenie. His pain was intense. The physician prescribed Vicodin which is hydrocodone plus acetaminophen. Hydrocodone does not have a dose limit per 24 hours, but the acetaminophen does because of the danger of liver damage. For days I danced between alleviating his pain and overdosing him with acetaminophen. His physician was not very cooperative. I wished for a different alternative, but there was none.

A new painkiller has been approved to come on the market this Spring made by Zogenix, Inc. It carries the name Zohydro. According to the FDA-approved labeling, Zohydro is “for the management of pain severe enough to require daily, around-the-clock, long-term opiod treatment and for which alternate treatment options are inadequate.” The manufacturer can’t market it for other uses, but doctors are free to prescribe it to any patient they deem appropriate. It is an extended release tablet which comes in doses as high as 50 milligrams per pill—five times the amount in the immediate release hydrocodone pills.    

There are many who oppose this move and, in fact, the FDA went against its own advisory committee who voted 12 to 2 against approval. The problem is the addictive nature of this drug and the fact that there are no safety measures to be taken to keep the drug from being abused. Drug abuse in this country from prescription drugs has been on the rise for several years. In 2010 the drug companies reformulated the opiod drugs where they could not be crushed and ingested, injected, or snorted for an immediate high at full dose. The acetaminophen has acted as a deterrent to addicts as they know it is toxic to the liver. Acetaminophen overdose is a leading cause of sudden liver failure in the United States. Nearly 2/3’s of those overdoses are traced to medications that include hydrocodone and acetaminophen.

Critics of the move for approval and release to market include many physicians and even members of the U.S. Senate. The other move that troubles the physicians is that the FDA is proposing moving all hydrocodone drugs to the DEA’s Schedule II. Hydrocodone mixed with acetaminophen, ibuprophen, or other compounds are now listed on Schedule III which means they can be ordered by phone and are refillable prescriptions. Schedule II requires a written prescription and no more than a month’s supply can be dispensed at one time.

These changes in pain medication will happen in 2014 and all of us will get our surprises at our local pharmacy.


  • Marilyn Sackett, MEd, RT(R), FASRT

    Marilyn Sackett is passionate about mentoring and education. She has experience establishing and teaching at the colligate level, she was a Director of Imaging for a large healthcare system in the Texas Medical Center, and she led the charge to improve radiation protection and licensure in the state of Texas, to this day she holds license #1 for radiology in the state. A former Ernst & Young Entrepreneur of the Year award winner and a Fellow of the American Society of Radiologic Technologists, Marilyn is a pioneer in radiology education.

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