Fentanyl Patch Warning by FDA

[Guest guest]

I have posted the FDA statement that was referring to in her

earlier posts. An important part of this warning recognizes that

healthcare givers be knowledgeable of the proper way to dose a new

user, and that they discuss all the potential side effects with the

patient. This was and is my concern about 's problems.

This statement is not a recall, it is an advisory of the potential

problems that could result with improper patch usage. I hope this

clears the air about what our discussion has been about.

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FDA Statement

FOR IMMEDIATE RELEASE

Statement

July 15, 2005

Media Inquiries:

Alvey,

Consumer Inquiries:

888-INFO-FDA

FDA Issues Public Health Advisory on the Fentanyl Patch

The FDA today issued a Public Health Advisory regarding the safe use

of transdermal fentanyl patches in response to reports of deaths in

patients using this potent narcotic medication for pain management. In

addition, a patient information sheet and an alert to healthcare

professionals were issued identifying several important safety

precautions for the use of fentanyl transdermal 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.

The FDA is conducting an investigation into the deaths associated with

these patches. The Agency has been examining the circumstances of

product 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 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 is working closely with the manufacturers of fentanyl

patches to fully evaluate the risks associated with their use and to

develop a plan to help patients avoid accidental fentanyl overdose.

For more information, go to:

http://www.fda.gov/cder/drug/infopage/fentanyl/default.htm.

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With love, hope and prayers,

Heidi

Heidi H. Griffeth

South Carolina Rep.

Southeast Regional Rep.

PAI

Note: All comments or advice are based on personal experience or

opinion only, and should not be substituted for consultation with a

medical professional.