US FDA Issues Safety Warning on Cancer Drug Fentora
A warning was issued by the US Food and Drug Administration on the 26thSeptember in respect of the drug Fentora. The warning followed a previous call made by its manufacturers, Cephalon Inc, earlier in September. Then, the firm advised doctors of several instances where Fentora had killed cancer patients after it had been prescribed at an inappropriate level.
Fentora is currently approved for the treatment of patients with cancer when conventional painkillers, such as morphine, fail to suppress pain to a manageable level.
The US FDA highlighted how paramount it is for doctors to prescribe Fentora in line with instructions, in order that fatalities, generated by overdosing, can be avoided.
In a statement issued by the Center for Drug Evaluation and Research’s Head, Steven Galson, confirmation was given that the “FDA is monitoring this issue very closely”.
In 2006, an investigation discovered Cephalon to be actively promoting some of its products for unapproved uses – a procedure that goes outside US law. In response to the latest news concerning Fentora, the firm stated that it is cooperating with the US FDA to establish a revised wording for its labelling, in order to effectively promote the new safety issues at hand.
On September 10th 2007, Cephalon wrote to professionals within the health industry in respect of Fentora. Referring to the instances where patients had died, Cephalon attributed these to either inappropriate selection of patients, dosage or substitution of drugs. Within this, it stressed how replacing another of its products, Actiq, with Fentora, should be avoided. In this regard, the US FDA described how, given Fentora’s tendency to provide the blood with higher levels of medication that Actiq, such substitutions could be linked, ultimately, to death.
According to Dr Scott Fishman - formerly the American Academy of Pain Medicine’s President – a prime issue here is the lack of training provided to doctors in respect of pain management. Consequently, he said, “Doctors will feel compelled to use whatever works", given that “There are a host of patients out there that need relief quickly.”
Source – Pharmaceutical International’s US Correspondent
