September 2007
The U.S Food and Drug Administration alerted healthcare professionals and consumers of the possible side effects of Fentora (fentanyl buccal) after reports of deaths and other adverse events.
Fentora, an opiod pain medication, is used only for the treatment of breakthrough pain in cancer patients already receiving opiod treatment who have become tolerant to it. Those who have not developed a tolerance for opiods are at risk of suffering the dangerous side effects associated with this drug. All deaths reported were a result of improper selection of patients, dosing, or improper product substitution.
"FDA is monitoring this issue very closely," said Steven Galson, M.D., M.P.H., director of FDA’s Center for Drug Evaluation and Research. "We are working with the manufacturer to ensure the safest use of this medicine. Health care professionals and patients need to be aware of the potential for fatal overdose with the improper use of Fentora."
The concern is that Fentora has been used as a quick acting pain medication and that its substitution for another fentanyl product, Actiq, results in more fentanyl being delivered to the blood and can result in a fatal overdose.
The FDA has warned doctors and other healthcare providers that it is critial to follow product labeling when administering Fentora and that it is extremely dangerous to use the drug to treat short-term pain for illnesses such as headaches or migraines.
[Source: FDA]
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» Drug Warnings and Withdrawls for 2007 from PharmaGazette
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