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BY OUR PHARMA CORRESPONDENT
July 16, 2005: Duragesic painkiller patches by John and Johnson may not be the ideal quick-fix solution; look before you leap -- that seems to be the US FDA's message to users of this fentanyl transdermal skin patch medication, currently under investigation by FDA over the deaths 120 users.
FDA is 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.
Since 1990, Duragesic has been marketed by Johnson & Johnson. Sales of Duragesic touched $1.2 billion in 2004, with over 4 million prescriptions filed. The 120 deaths are totaled from 1990. Already, in US, Duragesic has the most stringent caution called the “black box” warning.
The painkiller skin patch Duragesic contains fentanyl, a powerful narcotic as its active ingredient. The deaths may have been caused due to an overdose of fentanyl, which is like a morphine overdose where the patient become out of breath and fall into a coma.
For a layman's explanation of the potency of this drug, fentanyl was the drug which was pumped into a Moscow theatre when it was under militants' siege a few years back. The gas, pumped in powerful concentration, killed many of the militants and their hostages.
Some of the reported 120 deaths may have been due to overdoses by accident. Reports have said that patients using Duragesic fentanyl transdermal patches or those prescribing the skin patch were not aware of crucial safety informaton about the medication, according to Robert Meyer of FDA.
An overdose of Duragesic Fentanyl patches can create breathing trouble, which can be fatal. FDA has advised patients to seek emergency help if they face trouble in breathing or drowsiness with slow breathing, feel faint, dizzy or confused etc. These are unusual symptoms of Duragesic use and can be deadly.
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