FDA requiring visible fentanyl warning on Duragesic pain patches

patch FDA requiring visible fentanyl warning on Duragesic pain patchesPowerful narcotic fentanyl pain patches not only will have more visible warnings about deaths related to accidental exposure, but they were also added to the list of about 30 prescription drugs that should be disposed of by flushing down the toilet.

Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, will update the label on it Duragesic pain patch, which contains fentanyl. Fentanyl is a strong opioid medication used to treat severe, ongoing pain that cannot be controlled by other medications. The drug comes in various forms including a nasal spray and injection. Only the pain patches will carry the new, more pronounced warning.

The label changes come after numerous reports of injuries and deaths after children, pets and adults have inadvertently come in contact with fentanyl patches. They are especially lethal to children, who are smaller and typically have not previously been exposed to the drug. Patches that are not stuck to patients properly can fall off and pose an accidental exposure risk, as can patches that are not disposed of properly. Even used patches contain enough of the drug to cause serious injury or death.

The new, more prominent warning will be placed on the patches in red ink. Patients and caregivers are advised to fold the sticky parts of the used patches together and flush the patch down the toilet.

Flushing prescription drugs down the toilet raises environmental concerns; however, the Food and Drug Administration (FDA) says that the risks are outweighed by the benefit of protecting children from inadvertent exposure.

Fentanyl pain patches also come in generic versions. The FDA is requesting manufacturers of the generic product also update their warning labels in a similar fashion.

Source: Law360