Fentanyl Pain Patches Lawsuits - Duragesic Alert by Health Canada

Health Canada Issued Duragesic Alert

Fentanyl Pain Patches Alert. Health Canada has announced that the makers of Fentanyl Transdermal System patches are changing dosage guidelines in order to reduce the risk of fentanyl overdoses. The products involved in this alert include Duragesic patches made by Ortho-McNeil-Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson, as well as generic versions made […]

Health Canada has reminded health care providers

Health Canada has reminded health care providers that Fentanyl Transdermal Systems (patches) are only intended for use in patients who require continuous around-the-clock pain relief with strong narcotic pain relievers for an extended period of time and who are already taking narcotic pain relievers at a total daily dose of at least 60 mg/day Morphine Equivalents. The agency also said that the starting dosage of Fentanyl Transdermal Systems must be calculated using new conversion tables, and must not be higher than that dose which is comparable to the total dose of the narcotic drug the patient is receiving before they are switched to the fentanyl patch.

Health Canada also said that patients using Fentanyl Transdermal Systems should be advised to seek emergency medical help immediately if they:

have trouble breathing, or have slow or shallow breathing

have a slow heartbeat

have severe sleepiness

have cold, clammy skin

feel faint, dizzy, confused, or cannot think, walk, or talk normally

have a seizure

have hallucinations

Fentanyl patches have long been linked to accidental overdoses

Fentanyl patches have long been linked to accidental overdoses. Just last week, we reported that Ortho-McNeil-Janssen had recalled one lot of Duragesic 50 mcg/hr patches because of a defect that could cause fentanyl overdose. The recall also included one lot of Sandoz Inc. 50 mcg/hr patches.

Last February, the company also recalled 32 million Duragesic Pain Patches for a similar defect. At the time, it was estimated that about two out of every million patches could be defective.

In December 2007, the U.S. Food & Drug Administration (FDA) issued an alert, warning patients and doctors that there was a high danger of accidental overdose associated with the use of fentanyl patches, including the Duragesic Pain Patch. At the time, the FDA attributed the overdoses to patch “misuse” and ordered all fentanyl patch makers to create special “medication guides” for patients that spell out the dangers of overdoses and improper use in easy-to-understand language.

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