Fentora safety warning issued by FDA

September 28, 2007

FDA warns of adverse effects with buccal fentanyl use.

Following reports of deaths associated with improper use of buccal fentanyl (Fentora, Cephalon), the FDA has issued both a Public Health Advisory and a Healthcare Professional Sheet alerting clinicians and consumers of the serious side effects that can occur when the drug is misused. The agency reiterated that Fentora is indicated only for the treatment of breakthrough pain in cancer patients who have become tolerant to their current daily or around-the-clock opioid therapy, and that patients who develop tolerance are more resistant to the adverse effects than patients who take opioids on a less frequent basis. The agency also reminded clinicians that the buccal fentanyl is not the same as other fentanyl products and substitutions should not be made. The FDA has asked Cephalon to revise its labeling to improve dosing instructions and strengthen warnings of adverse effects. The agency has also requested that the company improve its education plan for healthcare professionals on patient selection, proper dosage, and substitution issues.

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