The US Food and Drug Administration has launched an investigation into the safety of pain-relieving patches that contain the narcotic medication, fentanyl, after they were linked to the deaths of several patients.
In a statement, the FDA said its investigation would aim to establish whether the deaths were due to inappropriate use of the product, or factors relating to its quality. “It is possible that some patients and their health care providers may not be completely aware of the dangers of these potent narcotic drug products and the important recommendations regarding their safe use,” the agency said.
Earlier this month, Johnson & Johnson, which manufactures the Duragesic (fentanyl) patch for chronic pain, strengthened safety warnings to highlight possible misuse and abuse associated with the product – fentanyl is an opioid drug, a class of drugs that have the highest potential for misuse and abuse, and have also been associated with fatal overdoses [[12/07/05f]]. Mylan Laboratories markets a copycat version of the patch [[01/02/05f]]. The agency says is working closely with the manufacturers to fully evaluate the risks associated with their use and to develop a plan to help patients avoid accidental fentanyl overdose.
The FDA has not specified exactly how many deaths had been linked to the patches, but the New York Times reports that around 120 people had died since Duragesic first won the green light back in 1990.
The agency has also issued a patient information sheet and an alert to healthcare professionals were issued identifying several important safety precautions for the patches’. These safety precautions include but are not limited to patient education regarding signs of overdose, proper patch application, use of other medications while using the patch, safeguards for children, and proper storage and disposal.