Other safety alerts
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| The United States: Duragesic (fentanyl) Patches: Drug Safety Communication - Packaging Changes to Minimize Risk of Accidental Exposure |
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The Food and Drug Administration (FDA) is requiring color changes to the writing on Duragesic (fentanyl) pain patches so they can be seen more easily. FDA continues to learn of deaths from accidental exposure to fentanyl patches.
Patients and healthcare professionals are reminded that fentanyl patches are dangerous even after they’ve been used because they still contain high amounts of strong narcotic pain medicine. Accidental exposure to these patches can cause serious harm and death in children, pets, and others.
In an effort to minimize the risk of accidental exposure to fentanyl patches, FDA is requiring the manufacturer of Duragesic to print the name and strength of the drug on the patch in long-lasting ink, in a color that is clearly visible to patients and caregivers. The current ink color varies by strength and is not always easy to see. This change is intended to enable patients and caregivers to more easily find patches on patients’ bodies and see patches that have fallen off, which children or pets could accidentally touch or ingest. The manufacturers of generic fentanyl patches are being requested to make similar changes.
Duragesic (fentanyl) patch is a strong prescription pain medicine that contains a narcotic opioid. It is marketed under the brand-name Duragesic and also as generic products.
Patients should be aware that patches that are not stuck to the skin tightly enough may accidentally fall off a patient and stick to someone in close contact, such as a child. Used fentanyl patches require proper disposal after use ― fold the patch, sticky sides together, and flush it down the toilet right away.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm369457.htm
In Hong Kong, there are six fentanyl –containing patches registered and are prescription-only medicines. Related news had been released by FDA and was posted on the Drug Office website on 20 April 2012. Letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug was issued on the same day. The Department of Health will keep vigilant on any safety updates of the drug and actions taken by overseas regulatory authorities for consideration of any action deemed necessary.
Ends/ Tuesday, September 24, 2013
Issued at HKT 12:30 |
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