The U.S. Food and Drug Administration (FDA) has approved labeling changes for powerful pain-relieving patches made by Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson. This was in response to a dozen instances of children dying after accidental exposure to the patches. The revisions announced last month by the FDA will result in Duragesic patches being stamped with long-lasting ink that more clearly indicates the presence and dosage of narcotic painkiller fentanyl. Makers of generic patches are being asked to take the same action. Previously, ink color varied by strength and “was not always easy to see,” according to the FDA. Douglas Throckmorton, deputy director of FDA’s Center for Drug Evaluation and Research, had this to say about the changes:
We hope that this change will enable patients and caregivers to more easily find patches that need to be removed from patients’ bodies and also to see patches that have fallen off, which could put children, pets or other household contacts at risk for accidental exposure.
In addition, the FDA added fentanyl patches to the list of prescription drugs that should be flushed down the toilet. About 30 products are already on that list, including Purdue Pharma LP’s OxyContin. While there are environmental concerns associated with flushing prescription drugs, the FDA felt the risk is outweighed by the goal of preventing children from inadvertently coming into contact with the medicines. Since 1997, a dozen children have died and another dozen have been hospitalized after accidentally using the patches.
Fentanyl patches are used for constant treatment of moderate to severe pain during the course of several days. They pose a risk to children if they come off and go unnoticed. There also is a risk when normal treatment is completed. That’s because the patches retain 50 percent of their strength after the regular three-day course of treatment. It should be noted that children are more susceptible to strong opioids, because they are smaller and also because they typically haven’t been previously exposed to the products. This makes matters worse. It should also be noted that J&J and Janssen have paid out millions of dollars in litigation for patch-related fatalities in recent years. Most of those lawsuits, however, dealt with design flaws issues. Mistaken use by children is a totally different issue.
The announcement last month follows an FDA warning in April about risks associated with fentanyl patches and advice to adults to closely monitor the products. The FDA says patches should be kept out of the reach of children, covered with adhesive tape if appropriate, and checked regularly to ensure they remain in place after being applied to a patient. According to Janssen, the company “is strongly committed to the safe use and disposal of Duragesic.” The company says it’s working with the FDA “to improve the visibility of the Duragesic patch.”
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