... 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, fentanyl 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.
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.