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Cephalon Inc's cancer painkiller Fentora was implicated in the deaths of four patients in Washington area, the drug company has revealed in a Dear Doctor letter sent out on September 10, 2007. The company said two of the deaths were caused by respiratory failure in patients who were prescribed the cancer painkiller for headaches.
Cephalon also sent out a Dear Healthcare Professional Letter on the same day warning that Fentora is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opoid therapy, the US Food and Drug Administration has revealed. Cephalon said the deaths occurred because of improper dosing of Fentora.
Fentora was approved by the FDA on September 25, 2006. The drug was made available on the market in the following month. Fentora contains the active ingredient fentanyl, which is an opioid agonist. It is a Schedule II controlled substance and has potential to be abused in a similar manner to other opoid analgesics.
According to the Dear Doctor letters issued by Cephalon
"FENTORA is indicated only for the management of breakthrough pain (BTP) in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, at least 25 rncg transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer."
If taken in inappropriate doses, Fentora can also trigger respiratory depression, which was thought to be responsible for two of the deaths reported to the drug maker. One death was thought to be a suicide, but the patient was not prescribed the drug by his doctor.
Cephalon has also asked doctors not to use Fentora for off-label prescriptions like headaches and back pain:
"Do prescribe FENTORA to patients who are opioid non-tolerant (i.e., patients who are not taking around-the-clock opioids). Do not prescribe FENTORA for patients with acute pain, postoperative pain, headache/migraine, or sports injuries, even if they are suitable for receiving other opioids on an as needed basis (F'RN)," the company said in its letter.
Cephalon spokeswoman Candace Steele confirmed that none of the patients who died from Fentora had cancer.
Meanwhile, the Wall Street Journal reports that Cephalon is being probed for its marketing of Fentora by a congressional probe as well as by the U.S. attorney in Philadelphia and the Connecticut attorney general. However Cephalon has denied marketing Fentora outside its indications.
The FDA said it had received the alert from Cephalon about the four deaths in Washington. "We have been monitoring this issue," said FDA spokeswoman Susan Cruzan. "The FDA takes this very seriously, and we are working with the company to assure the safest possible use of this medication.
Following is the information released by Cephalon for Fentora:
Key Safety Information regarding FENTORA:
* Do NOT use FENTORA in opioid non-tolerant patients
* Use FENTORA only for labeled indications
* Do not prescribe FENTORA for patients with acute pain, postoperative pain, headache/migraine, or sports injuries
* FENTORA is not a generic version of Actiq. Therefore, do NOT substitute FENTORA for Actiq or other fentanyl-containing products
* Follow dosing instructions carefully:
* For unrelieved breakthrough pain (BTP), patients should NOT take more than 2 FENTORA tablets per BTP episode
* Patients MUST wait at least 4 hours before treating another BTP episode with FENTORA
If consumers or healthcare professionals have any questions, they are encouraged to contact Cephalon at 1-800-896-5855.
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