FDA Issues Advisory on Cephalon Drug

On Wednesday the Food and Drug Administration issued a public health advisory in light of reports of deaths and other adverse events related to the use of Cephalon's(CEPH) Fentora (fentanyl buccal) tablets, used for breakthrough pain in cancer patients.

Earlier in September, the FDA posted a product safety alert when Cephalon issued letters warning of deaths and serious adverse events that resulted from improper patient selection, improper dosing and/or improper product substitution.

Breakthrough pain is intense increases in pain that occur with rapid onset. Patients who take narcotic pain medications regularly on an around-the-clock basis develop higher tolerance and are more resistant to the dangerous side effects than patients who take narcotic pain medication on a less frequent basis, the FDA noted.

In a Public Health Advisory and Health Care Professional Sheet published Wednesday, the agency warned physicians and other health care professionals again that it's critical to follow product labeling when administering Fentora. The FDA further said that it's dangerous to use Fentora for any short-term pain such as headaches or migraines, and it's critical that Fentora not be used in patients who are not opioid tolerant.

Cephalon shares were up 11 cents, or 0.2%, at $72.57 on Wednesday.

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