Fentanyl Pain Patch Recall

Last week, PriCara, and Actavis Group, both announced that Fentanyl Duragesic Patches were being voluntarily recalled as a precaution from wholesalers and pharmacies.

Fentanyl pain patches are designed to deliver a controlled dose for patients suffering from moderate to severe chronic pain that cannot be treated by a combination of narcotic, short-acting or non-narcotic pain products. Fentanyl a is a powerful narcotic gel that if comes in direct contact with a patient’s or caregiver’s skin, it may cause difficulty breathing, produce life-threatening side effects and even death.

I’ve often wondered how much manufacturers know about their product before it goes out the door. In the case of the Fentanyl patch recall, did someone go “Oops! I messed up these patches, but no big deal, nobody will notice”. Did someone further down the line notice and not say anything? Did someone actually take responsibility and notify management that there was a problem? Did management listen. Or, did they choose to ignore it and figured the cost of a recall (and even a few lawsuits) is more cost effective than stopping production. Was it a faulty design? How many people were either injured or died before this product was recalled. These are all questions I wonder about whenever I come across a new recall.

According to the FDA website, Activis claims they are “unaware of any injuries resulting from this issue” and “as a precaution, is recalling these lots.”

Yet, in June 2007 the family of 28 year old Adam Hendelson was awarded $5.5 million by a Florida jury. Hendelson died while wearing a fentanyl patch and tests confirmed that he had three times the leathal dose of fentanyl in his system at the time of his death.

Imagine my surprise, after further research I found that this is not the first recall of Duragesic pain patches. In 2004 fentanyl patches were recalled over a similar issue and in 2005, the Food and Drug Administration issued an alert in response to a number of deaths potentially linked to defective patches.

I’m no rocket scientist, but if this is not the first recall and there was a $5.5 million judgement, then it answers one of my questions…did management know about the problem? Seems like they did.