tpm 02 insulin, page-25

Hi ferret

The main opiod transdermal patch is the DURAGESIC CII fentanyl patch introduced by Janssen Pharmaceutica in the mid-1990s. Fentanyl is a potent synthetic (man-made) narcotic with a rapid onset and short duration of action.

"The Duragesic patch, which is a formation of an inert alcohol gel infused with select fentanyl doses which are worn to provide constant administration of the opioid over a period of 48 to 72 hours.

Following the patch, a flavored lollipop of fentanyl citrate mixed with inert fillers was introduced under the brand name of Actiq, becoming the first quick-acting formation of fentanyl for use with chronic breakthrough pain. More recently, fentanyl has been developed into an effervescent tab for buccal absorption much like the Actiq lollipop, followed by a buccal spray device for fast-acting relief and other delivery methods currently in development.

A new Fentanyl product has just been approved by the FDA for breakthrough cancer pain called Onsolis. It uses a new drug delivery technology called BEMA (fentanyl buccal soluble film) which is placed in the mouth on a small disc. There appears to be less abuse potential because the drug can not be crushed up and snorted like other fentanyl product. It also has a lower incidence of mouth ulcers for patients using fentanyl for breakthrough cancer pain." [http://en.wikipedia.org/wiki/Fentanyl].

According to the Johnson & Johnson subsidiary's website [www.duragesic.com] the patch "contains a high concentration of a potent Schedule II opioid agonist, fentanyl. Schedule II opioid substances which include fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone have the highest potential for abuse and associated risk of fatal overdose due to respiratory depression. Fentanyl can be abused and is subject to criminal diversion. The high content of fentanyl in the DURAGESIC patches may be a particular target for abuse and diversion."

They warn: "Since the peak fentanyl concentrations generally occur between 20 and 72 hours of treatment, prescribers should be aware that serious or life-threatening hypoventilation may occur, even in opioid-tolerant patients, during the initial application period."

"DURAGESIC is ONLY for use in patients who are already tolerant to opioid therapy of comparable potency. Use in non-opioid tolerant patients may lead to fatal respiratory depression."


Now in February 2008, Johnson & Johnson were forced to recall their Duragesic Pain Patch, due to problems with leaking.

A transdermal patch is used for a very controlled dosing of medication over time.

The problem with a leak is that the amount of medication is then unregulated. In the case of the Duragesic Pain Patches, one of the seals on the patch membrane wasn't properly containing the medication. The fentanyl spilled out onto the patients' skin, under the adhesive where it was often not noticed.

Overdosing causes quite a few problems for patients using fentanyl. As a drug that is close to 100 times more powerful than morphine, the biggest problem is difficulty breathing. If left untreated, the overdosing causes a patient to slowly slip into a coma and die. [www.duragesicpatchrecall.com].

This design fault also applied to the generic versions of the Duragesic Pain Patch, produced by Sandoz, Cephalon and Nycomed.

Sorry it's so long...