Fentora Cancer Pain Drug Linked To Deaths
Fentora (fentanyl buccal tablet)
has been linked with four deaths recently.
From www.MedicalNewsToday.com
By Catharine Paddock, Medical News Today
September 14, 2007
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).
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