Alvogen recalls mismarked fentanyl patches over overdose concerns

Alvogen is recalling two lots fentanyl patches because some cartons may contain patches with much higher doses than the cartons indicate. (Alvogen)

The highly effective but highly addictive properties of fentanyl have made it a drug that has figured prominently in national concerns over opioid addiction. A drugmaker is now recalling two lots of mismarked fentanyl patches because they could lead to overdoses.

 Drugmaker Alvogen is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level be “a small number of cartons” labeled as 12 mcg/h actually contain 50 mcg/h patches, according to the notice distributed Friday by the FDA.  The transdermal system is manufactured for Alvogen by 3M Drug Delivery Systems in St. Paul, Minnesota.

Alvogen says the individual patches are properly labeled but if the wrong dose patch is used, it could lead to “serious, life-threatening, or fatal respiratory depression.” No adverse events have been reported to the drugmaker but patients are warned that if they are wearing a mislabeled patch they should remove it immediately.

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According to the National Institute on Drug Abuse, in 2016 synthetic opioids, primarily illegal fentanyl, overtook opioids for overdose-related deaths, reaching 50%, up from 14% in 2010. The drug is similar to morphine but is 50 to 100 times more potent.

Much of the fentanyl spotlight in the last few years has shined on Insys, a small drugmaker that became the target of DOJ prosecutions and Congressional hearings for its aggressive marketing of its fentanyl spray Subsys. Last August, Insys agreed to settle a federal probe into its Subsys sales practices for $150 million. More recently, Insys’ sales strategies for the drug have played out in court in the racketeering trial of Insys’ billionaire founder John Kapoor and four other executives.

In an annual securities filing last month, Insys said it faces investigations from Congress, the Department of Health and Human Services, the U.S. Attorney’s Office for the District of Massachusetts, the SEC and numerous states. The company just last week named CFO Andrew Long its new chief executive as it tries to recover from the ongoing legal traumas.