Cephalon’s FDA Warning More of a Formality (CEPH)

Cephalon Inc. (NASDAQ:CEPH) is a biotech that has been under a bit of a low ceiling after its recent blunder regarding FENTORA.  As a reminder FENTORA is that cancer pain drug that the company issued "Dear Doctor" alerts about the potential side effects possibly leading to deaths.  The company said it believes that the deaths were the result of improper matches, improper dosing, and substitutions for other drugs. 

Cephalon gave its own warnings on this, and today the Food & Drug Administration has sent out communication of its own with warnings to pay close attention to the same issues.  Of course it included that the FDA was closely reviewing and monitoring the situation.  The long and short of it is that this is a mere formality out of the FDA and would have been expected.  There is not really any new data in the FDA letter, other than the fact the letter is out now.

Jon C. Ogg
September 26, 2007

Below is a copy of the electronic communication from the FDA:

FDA Warns of Potential Serious Side Effects with Breakthrough Cancer Pain Drug

The Food and Drug Administration isalerting health care professionals and consumers to concerns over theuse of Fentora (fentanyl buccal) tablets after recent reports of deathsand other adverse events.

Fentora, a potent opioid painmedication, is used only for treatment of breakthrough pain in cancerpatients receiving opioid treatment and who have become tolerant to it.Breakthrough pain is intense increases in pain that occur with rapidonset, even when opioid pain-control medication is being used.Patients who take narcotic pain medications daily and around-the-clockdevelop tolerance and are more resistant to the dangerous side effectsof these medications than patients who take narcotic pain medication ona less frequent basis. 

The deaths reported were the result of improper selection of patients, dosing, or improper product substitution.

“FDA is monitoring this issue veryclosely,” said Steven Galson, M.D., M.P.H., director of FDA’s Centerfor Drug Evaluation and Research. “We are working with the manufacturerto ensure the safest use of this medicine. Health care professionalsand patients need to be aware of the potential for fatal overdose withthe improper use of Fentora.”

In its Public Health Advisory andHealth Care Professional Sheet published today, FDA warned physiciansand other health care professionals that it is critical to followproduct labeling when administering Fentora. FDA further stated that itis dangerous to use Fentora for any short-term pain such as headachesor migraines. It is critical that Fentora not be used in patients whoare not opioid tolerant. 

Patients also must be under a doctor’scare and close supervision while taking Fentora and the dose should becarefully adjusted to control breakthrough pain adequately.

In addition, FDA is concerned about theimproper substitution of Fentora, a quick acting pain drug, for otherpain medicines.  Fentora is not the same as other fentanyl products andcannot be substituted for Actiq, another fentanyl product used to treatbreakthrough cancer pain. Because Fentora delivers more fentanyl to theblood than Actiq, substituting Fentora for Actiq using the same dosecan result in a fatal overdose.

On Sept.10, 2007, Cephalon Inc., themanufacturer of Fentora, sent letters to physicians and other healthcare providers advising them about the adverse events and deathsreported for Fentora. FDA is reviewing available information includingadverse events. The agency has asked the company to strengthen warningsand improve the dosing instructions in the drug’s product labeling.FDA also requested that the company improve their education plan forprescribers and pharmacists on the proper patient selection, dosinginstructions and restrictions on substituting Fentora for otherproducts.

Adverse events related to this product should be reported to MedWatch, the FDA’s voluntary reporting program: www.fda.gov/medwatch/report.htm