Watson's Fentanyl Patch Recall Is 6th So Far; Why Don't Patches Work?
Watson Pharmaceuticals has issued a recall for its fentanyl painkiller patch product, some of which have leaked. The company said:
… exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal.
By BNET’s count, this is at least the sixth fentanyl patch recall since 1994. As Internet Drug News points out:
For some reason, fetanyl patches get recalled once or twice a year. If they come up with an airplane called Fentanyl patch, don’t get on it.
The Watson recall again raises the question of whether fentanyl patches are too dangerous to be on the market, and whether transdermal patch delivery of drugs generally is a good idea or not.
Look at the history:
In June, Wilco songwriter Jay Bennett was killed due to an accidental overdose delivered by a fentanyl patch.- Johnson & Johnson issued recalls of its Duragesic fentanyl patch in January 2009 and february 2008.
- At least three people have brought lawsuits claiming family members were killed by fentanyl patches.
You can get an idea of the problems involved with patches by looking at other drugs that have patches.
Shire and Noven have a joint venture on the Daytrana ADHD patch. Noven has had ongoing problems getting its patch to work; patients and caregivers have difficulty peeling the backs off them. Noven twice issued product recalls on its patches in 2008, and issued another recall in March 2009, according to its Q2 2009 10-Q filing. Noven paid Shire a $3.4 million fee and wrote off $4.2 million in charges this year over the recall. The recall followed a February 2009 citation by the FDA of Noven’s Daytrana factory. The FDA cited Noven’s manufacturing issues on the patch back in 2007, also. The Daytrana patch has been banned from the market in Europe. Shire recorded only $14 million in Daytrana patch sales in Q2, a 77 percent decline. Yet the company has applied to the FDA for an adolescent indication for the patch.
Shire and Noven’s troubles came after J&J all but abandoned marketing of its Ortho Evra birth control patch. About 40 women died from blood clots triggered by that patch.
Why are patches so troublesome? As BNET suggested after Bennett died, the main problem with patches is that they pass the pure drug into the patient’s system at a constant, unmediated rate, on a permanent basis (the patches are meant to be worn indefinitely). Drugs are sometimes given this way to patients for extremely serious conditions — in the form of IV lines, for instance — for temporary periods. Yet patches utilize a similar continuous regimen for non-life-threatening conditions on an indefinite basis.
And for all these indications — pain, ADHD and birth control — there are alternative delivery methods that don’t have such a controversial history.
Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.
BNET User Analysis