Fentora Cancer Pain Drug Linked To Deaths

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Main Category: Pain / Anesthetics
Also Included In: Cancer / Oncology;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 14 Sep 2007 - 4:00 PDT

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Drug company Cephalon has sent out a Dear Doctor and a Dear Healthcare Professional letter about safe use of its cancer pain drug Fentora (fentanyl buccal tablet) which has been linked with four deaths recently.

The letters, dated 10th September, remind pain management specialists and other healthcare professionals that Fentora should only be used to manage breakthrough pain in patients with cancer who are already taking, and are already known to be tolerant, to opioids (substances that act like morphine), for their underlying persistent cancer pain.

According to the drug company some patients have died and serious adverse events have occurred linked to Fentora because of "improper patient selection (e.g., use in opioid non-tolerant patients), improper dosing, and/or improper product substitution". The patients who died were not appropriate candidates for Fentora, they wrote.

According to a report by the Associated Press (AP), two of the people who died had been prescribed the drug as a headache treatment, a third died because they took the wrong dose and the fourth case involved a suicide. None of the people who died were cancer patients, leading the drug company to believe they were inappropriate candidates, said a spokeswoman from Cephalon.

The letters remind doctors and healthcare professionals that:

• Fentora must only be prescribed to cancer patients who are "routinely taking around-the-clock opioids".
• The drug is indicated for management of breakthrough pain.
• The patient must already be receiving opioid therapy for persistent underlying cancer pain.
• The patient must be known to be tolerant to opioids before receiving Fentora.
• Fentora should not be used to treat: acute pain, postoperative pain, headache/migraine, or sports injuries.
• Patients should take no more than one tablet per episode once a dose is established.
• Patients must wait at least four hours before taking another dose.
• Fentora should not be substituted for any fentanyl-containing pain medication, including Actiq (oral transmucosal fentanyl citrate).

The letters explain that Fentora is neither a bioequivalent nor a generic version of Actiq.

Fentora contains the active ingredient fentanyl, a Schedule II controlled substance, with a high potential for abuse and overdose, which leads to respiratory depression and death.

Fentanyl is a potent analgesic and opioid agonist, like morphine, methadone, oxycodone, hydromorphone, oxymorphone, and has a similar abuse liability as these drugs.

Although physicians should be aware of the potential for misuse when prescribing any drug, in the case of Fentora and other opioids they need to be extra careful because of the high potential for misuse, abuse, or diversion of these substances.

Fentora received FDA approval in September 2006, since when 78,000 prescriptions have been filled for the drug, according to the drug company.

Click here for further information on Fentora and links to the two letters from Cephalon (FDA).

Written by: Catharine Paddock


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