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Lethally Addictive Painkiller Recalled 7 Times While FDA Twiddles Its Thumbs

Actavis has recalled of some of its fentanyl painkiller patches, but the company's press release obscures how lethal the product actually is. Fentanyl is a highly addictive opioid painkiller that can kill you if used wrongly. By my count, this is the seventh recall of fentanyl patch products, which suggests that the FDA ought to look at whether this product is safe enough to stay on the market. Actavis' release says:

An accelerated release of Fentanyl from a 25 mcg/hour patch can lead to adverse events for at-risk patients, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing). The patches are packaged individually and boxed in quantities of five patches per box.
In plain English, fentanyl can stop your breathing completely and permanently. This is not an unusual event with fentanyl. Wilco songwriter Jay Bennett was killed by a fentanyl patch. Fifty-six patients at this Kansas clinic were killed by fentanyl overdoses. Johnson & Johnson (JNJ) lost a series of cases in which patients died taking Duragesic, the original branded version of fentanyl.

The latest recall occurred because the patches released the drug too quickly. But the total number of recalls -- especially if you consider the nine recalls of the Daytrana patch for ADHD, that Shire (SHPGY) literally gave up making that product because it wasn't reliable enough, and that J&J has settled all its suits on another patch product, the Ortho Evra birth control patch, because that product also delivered too much medicine too quickly -- strongly indicates that transdermal patches are an inherently problematic way of delivering drugs. Time for the FDA to act.


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