On July 15, 2005, the FDA issued a Public Health Advisory warning of the potential danger of transdermal fentanyl patches in response to reports of deaths in patients using this potent narcotic medication for pain management - including the generic product manufactured by Mylan Laboratories.
The Mylan form of the medication has had a brief and tumultuous history. On Feb. 2, 2005, after a lengthy battle, the FDA approved the first generic version of the Duragesic Patch to treat people with severe chronic pain, and was sold by the company under the name Fentanyl Transdermal System.
The FDA is conducting an investigation into over 120 deaths associated with these patches. The Agency has been examining the circumstances of patient patch use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product.
It is possible that some patients may not be completely aware of the dangers of these potent narcotic drug products and the important recommendations regarding their safe use. If you are using a Fentanyl pain patch - whether the Duragesic brand or a generic medication from Mylan Laboratories, you should seek medical guidance immediately.
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