New Opioid Pain Patch

by Jim Orr

In July of 2010, the FDA approved a new opioid pain patch containing Buprenorphine called Butrans.  Previously, the only opioid pain patch available in the US was a pain patch containing Fentanyl (e.g., Duragesic, Sandoz, Mylan).   This new product (available in Europe for years) is a welcome advancement in US patient safety.  While Buprenorphine is equally effective in treating pain as Fentanyl, it does not present the same risk of death due to respiratory depression as Fentanyl patches.  This is due to the fact that Buprenorphine has a ceiling effect on respiratory depression.  In other words, if the level of Buprenorphine in the blood gets too high, it starts preventing respiratory depression instead of causing it.

A replacement for Fentanyl patches has been greatly needed for a long time due to the many unnecessary deaths of patients using Fentanyl patches.  From 1998 to 2005, Fentanyl was the second most cited drug in serious and fatal adverse event reports to the FDA.  Yet, during this time frame, Fentanyl was not even in the top 150 most prescribed drugs.  The risk of death associated with each use of a drug is known as its “relative lethality.”  The relative lethality of Fentanyl (especially Fentanyl patches) is very high since there have been thousands of deaths but yet it is not a drug that is in widespread use.  In comparison, a drug with very low “relative lethality” is acetaminophen.  While many people die each year from acetaminophen poisoning, it is the most commonly used drug in the world, with over 28 billion doses taken every year.   Thus, it is an extremely safe drug and deaths are generally related to consuming large quantities of the drug at once or taking it on a daily basis along with alcohol.

Fentanyl patches are extremely dangerous because if the patch delivers too much Fentanyl or if the patch is not properly prescribed, the patient does not recognize that they are developing fatal respiratory depression because they never feel ill.  Instead, the patient may feel euphoric, get sleepy and lay down to sleep, only to never wake up.  Fentanyl is an extremely potent opioid pain medication that is 100 times stronger than morphine, and it has a very narrow therapeutic window.  This means that the margin of error between what provides pain relief and what can cause death is small.  Rendering this product even more dangerous is the fact that even if the patch is removed, it has already delivered large quantities Fentanyl to the layers of skin under the stratum corneum.  The Fentanyl is stored in these under layers of skin and will continue to enter the blood stream long after the patch is removed.  This is called the skin depot effect.  As a result, a patient can remove the patch thinking that this will eliminate any further possibility of overdose, only to die from subsequently delivered Fentanyl from the skin depot.

Many lives should be saved by this new product!  For more information regarding Burtrans, please go to

Heygood, Orr & Pearson is the leading law firm in the country handling Fentanyl patch related cases.  To consult with Heygood, Orr & Pearson, please email us at