The problem, according to Janssen-Cilag’s executive communications director Siegfried Marynissen, is related to corrosion of one of Ionysis’ circuit boards that may “trigger the self-activation of the system,” although its root cause has yet to be determined.
Marynissen explained that: “Approximately 13,000 systems have been distributed in Europe, representing four separate lots. The defect was observed in one lot. It's not known if this defect was present in all of the lots that were distributed.
“As a result the company decided to recall all lots of the product that were on the market as a precautionary measure. There have been no reports of serious adverse events associated with the malfunction of the device, in particular no reports related to self-activation of the system, or of overdose,” added Marynissen.
The European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP), which was made aware or the problem by Janssen in September, recommended withdrawing Ionysis’ marketing authorisation which was originally granted in January 2006.
The EMEA, which failed to respond to in-PharmaTechnologist’s questions, is expected to reach a final decision early next month.
US fentanyl market
Fentanyl’s considerable potency, it is around 80 times more powerful than morphine, means that overdoses can be fatal. In recognition of this risk regulatory agencies worldwide strictly control its use in pharmaceutical products
In the US in particular 2008 has been a turbulent year for fentanyl producing companies. In February, Ortho-McNeil-Janssen, said that all lots of 25 mcg/hour Duragesic (fentanyl transdermal) patches were being withdrawn voluntarily "as a precaution."
The following month, Actavis Totowa was also forced to recall all lots of its painkilling patch products after it identified a possible fold-over defect present in the product that might cause leakage of the fentanyl gel.
On a more positive note for the sector, in October the US Food and Drug Administration cleared a fentanyl delivery patch made by Israeli generics firm Teva, ushering the firm into a market that was worth $1.2bn in the 12 months to June, according to IMS health.