Posts Tagged ‘new hydrocodone’

New Drug, Old Problems?

The internet is abuzz with dire predictions surrounding the release of a more potent form of hydrocodone. Two drug companies have announced their intent to release a hydrocodone pill with a higher content of hydrocodone, with no acetaminophen. Currently, hydrocodone is available in doses of 5, 10, and 7.5mg per pill, combined with 325 or 500mg of acetaminophen (generic drug name of Tylenol). Teva Pharmaceuticals, based in Israel, has announced their intention to release a newer, higher potency form of hydrocodone that contains 45mg per pill.  If it’s approved by the FDA, it will contain over four times the opioid firepower in one pill that the next highest dose now on the market. Teva pharmaceutical is predicting up to $500 million in sales.

It’s a little early to start saying we’re going to have another OxyContin on our hands. Since 2009, the FDA demands each pharmaceutical company that manufactures powerful opioids have a plan in place, prior to the release of a new medication, to reduce the risk of harm to the public. This program is called “REMS” for “risk evaluation and mitigation strategy.” Before a higher strength hydrocodone can be released, the manufacturer must assure the FDA that all proper precautions are being taken to avoid excessive misuse and addiction.

We will never reduce medication misuse to zero, but we can learn from the past, and use available technologies to reduce the potential for drug misuse, to prevent another version of the OxyContin situation. Teva calls its product “TD” because it’s tamper deterrent, but I can’t find any information on which technology they plan to use. It will be a sustained-release preparation that is taken once every 12 hours.

Another company, Zogenics, is preparing to release Zohydro, their brand of higher dose version of hydrocodone. They say their version contains no tamper-resistant technologies.

Do we need another high potency, long-acting opioid for pain? And do we need it at a time in history when we’re on the crest of an opioid addiction epidemic? Some experts say yes, for a startling reason: We are seeing liver failure from acetaminophen overdoses.

According to one article, the most common cause of acute liver failure is acetaminophen, the generic name of the brand Tylenol. In 1998, liver failure from acetaminophen made up only 23% of the total number of liver failure cases, while in 2003, it rose to 51% of all acute liver failure cases. Of the people with unintentional acetaminophen overdoses, 63% were taking opioids containing acetaminophen, sometimes in combination with other medication that also contained acetaminophen. (1)

There’s not a wide margin of safety with acetaminophen.  The upper limit of what’s considered to be safe is about 3 grams per day of acetaminophen, but if the person has underlying hepatitis B or C, or damage from alcohol ingestion, not even 3grams is a “safe” dose. Some hydrocodone preparations now contain 500mg per tablet, so even at therapeutic doses that’s coming close to a toxic level of acetaminophen.

Opioid addicts often take much more hydrocodone than prescribed, regardless of the amount of acetaminophen. Addicts often take 15 or 20 pills of hydrocodone per day, which could be as much as 10grms of acetaminophen per day. And they take this day after day. An ordinary person might ask, “Why would anyone take the risk of damaging their liver like that?” But that’s addiction. Addiction is about loss of control. I’ve heard dozens of addicts entering treatment voice concerns they’ve damaged their livers because of pain pill use. They describe the curious predicament of taking pills because the addiction compels them to do so, all the while hoping they won’t die from liver failure. It’s a strong statement about the strength of addiction.

While acetaminophen-free hydrocodone may not trash your liver, it can still trash your life, if you become addicted.

  1. Larson AM et al, “Acetaminophen-induced Acute Liver Failure: Results of a U.S. Multicenter, Prospective Study,”  Hepatology, 2005;42:1364-1372.