Wilco's Bennett Killed by Fentanyl; Is It Time to Tighten Rules on Patch Drugs?

(MoneyWatch)  An Illinois coroner said Wilco songwriter Jay Bennett died of an accidental overdose from a fentanyl painkiller patch. The death should give the pharmaceutical industry pause to ask whether patch delivery systems should be subject to higher standards before being approved.

Fentanyl patches, marketed as Duragesic by Johnson & Johnson's PriCara unit and also available as generics, are for opioid-tolerant patients who need round-the-clock pain relief. Fentanyl is also highly addictive, about 100 times more potent than heroin. Bennett was using the patch to dull pain from his hip, which he injured performing, according to the Chicago Tribune. He did not die from recreational drug use, the coroner noted. (It is not known whether a J&J or generic patch killed him.)

The problem with patches is that they use a structurally inappropriate organ to deliver medicine -- the skin. If a drug can be persuaded to pass though the skin, it enters the blood at a constant, unmediated rate. (By contrast, a drug swallowed as a pill will be digested, and the dose in the blood will rise and then fall before the next pill is taken, giving the body a "rest" between metabolism tasks.) A constant rate of dose delivery sounds great on paper -- doctors can be sure of more accurately delivering the correct amount of medicine. But because transdermal patches don't give patients' bodies a rest, patients may end up getting too much drug -- as Bennett did.

The history of skin-patch transdermal delivery systems is an unfortunate one. Whether it's contraception, painkillers or ADHD drugs, they are plagued with problems. Here's a list:

• Shire's Daytrana ADHD patch was kicked out of Europe and has had two recalls in the U.S. because customers couldn't peel the backs off the stickers. Shire supplier Noven said it expected the problem to continue.
• Johnson & Johnson's PriCara unit previously recalled two lots of its Duragesic fentanyl pain patch.
• J&J issued a similar recall in February for a larger batch of patches.
• This RTT report says that there have been five Duragesic/fentanyl recalls since 1994.
• J&J has lost at least three lawsuits in which there were fatalities involving patch overdoses.
• A different J&J patch, the Ortho Evra birth control patch, has also had excess-delivery-of-drug problems. J&J paid $68 million to settled hundreds of cases in which plaintiffs claimed they had ben given strokes, embolisms and heart attacks by Ortho Evra. (Estrogen-based birth control increases blood-clot risks.)
• The Ortho Evra patch allegedly killed 40 women, and the company stopped actively marketing it -- although the product remains on the market.

• Previously on BNET:
• Duragesic Recall Causes More Patch Woes for J&J
• J&J Loses 3rd Duragesic/Fentanyl Patch Death Case; $16.5 Mil. Verdict