The FDA recalled Tuesday all the patches (25-microgram-per-hour patches with expiration dates on or before December 2009) containing fentanyl, because it can have a serious defect.
Fentanyl, (Duragesic and Durogesic are the trade names) is used to moderate severe pain and bring relief. One patch may provide 72 hours of pain relief.
Since Duragesic and Durogesic are highly potent, there are many black box warnings in their prescribing information. Additionally, due to the risk of serious adverse drug reactions, it is highly important that the patches be applied correctly and as prescribed.
The patches are said to have a cut in the lining of the internal reservoir where the drug is stored in gel form. If the fentanyl gel leaks into the drug's packaging, and in case of direct contact with this powerful "opioid" drug, one can have difficulty in breathing and a potentially fatal overdose.
The choice of the city of Helsinki is not incidental as the capital of Finland had hosted US-Soviet negotiations on the limitation of nuclear stockpiles in 1969