The National Medicines Agency indicated Thursday, January 24 to recall a batch of Pecfent 400. The bottles of this solution for nasal spraying have a manufacturing defect exposing them to a risk of overdose.
In a press release dated Thursday, January 24, the National Medicines Safety Agency (ANSM) has announced that it is recalling a batch of medicine, Pecfent 400. This solution for nasal spray, indicated for treating bouts of paroxysmal pain in adult patients already receiving treatment for chronic cancer pain, contains a powerful opiate, fentanyl. The recalled batch has a vial closure defect, which exposes to a risk of overdose.
A risk of respiratory depression
It is for the moment a simple “precautionary measure” in order to avoid any risk to health, indicates the Medicines Agency. In the event of an overdose, fentanyl can indeed cause “significant and immediate toxicity after taking, the most serious major effect of which is respiratory depression”, that is to say sudden respiratory distress that can lead to state of cardio-respiratory shock which can be fatal. No case of gender has yet been listed, assures the ANSM.
According to the Kyowa-Kirin laboratory which markets Pecfent 400 micrograms/spray, the manufacturing defect concerns the batch 5430717 (expiration 10/2020). Failure to close the bottle may lead to evaporation of the solution, responsible for an increase in the concentration of fentanyl. However, the laboratory informs via the ANSM that in France this defect “only concerns some of the 19,000 boxes of the batch” distributed between July 2018 and January 2019.
What to do when using a medicine from the Pecfent 400 batch?
“Patients who have boxes of lot 5430717 are asked not to or no longer use them and to return them to their pharmacy as soon as possible. New boxes will be provided to them free of charge in exchange”, specifies the ANSM.
Fentanyl overdoses, a real public health issue in the United States
If the Kyowa-Kirin laboratory and the ANSM are recalling the defective batch of Pecfent 400, it is because fentanyl can wreak havoc. On the other side of the Atlantic, in the United States, this synthetic opioid, up to 100 times more powerful than heroin, is responsible for more than a third of the 64,000 fatal overdoses recorded during the year 2016. Since 1999, the number of deaths caused by synthetic opioids like fentanyl has increased by 3,000%.
