July 18, 2005
The FDA announced it is investigating 120 deaths and other serious effects among users of a patch that emits the strong narcotic painkiller fentanyl. Because of the potentially fatal effects, a public health advisory was issued stating some patients and doctors might not be fully aware of its dangers for accidental overdose.
The agency does not know if the deaths are related to inappropriate use of the painkilling skin patches or if they are a reflection of the product’s quality. The advisory warned patients to use the patches exactly as prescribed and to be aware of any sings of possible overdose, including breathing difficulties, extreme tiredness and feelings of faintness or dizziness. An overdose can cause a person to stop breathing, and failing to recognize early signs can be very dangerous since removing the patch will not reverse the effects since the drug has already built up in the person’s system and may continue to be absorbed from the skin for 17 hours or more.
If users experience any symptoms indicating overdose, emergency help should be sought. First approved in 1990, a generic version of Duragesic was put on the market in February by Mylan Laboratories.
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