The warning doesn't sound much different than for any other opioid. All of them, especially morphine, can cause the same thing if one OD's or combines it with alcohol or interactions with other drugs. We had a pharmacist here, years ago, commit suicide with Fentanyl patches.

You must understand how the FDA deals with so-called "adverse effects". If they receive ANY adverse effects reports then they require the manufacturer to add it to the adverse effects list in their package labeling. 120 deaths in a drug that sells 2 billion in sales a year is probably a statistically very small number. The adverse effects reporting requirement in the Code of Federal Regulations (see http://frwebgate.access.gpo.gov/cgi...p;SECTION=80&YEAR=2001&TYPE=TEXT to see for yourself just confusing this is - that's why they pay me the big bucks as a regulatory affairs VP -lol) how often leads to contradictory information and many times pratically renders the whole process somewhat useless.

Excerpt from the "Dear Doctor Letter" See http://www.fda.gov/medwatch/SAFETY/2005/duragesic_ddl.pdf for the entire letter:
"The changes reflect FDA