There has been yet another falsified medicine report from the German authorities, this time a knock-off copy of Janssen-Cilag's maintenance schizophrenia therapy Xeplion.
The counterfeit batch – which mimicked the packaging for the drug in Bulgaria and Romania – was of a 150mg intramuscular injection formulation of the antipsychotic drug and carried the batch number GFB4D00 and an expiry of 05/2018, according to a report from the Czech medicines regulator SÚKL, citing Germany's BfArM.
Xeplion is a prolonged-release (depot) formulation of paliperidone that is generally used to manage schizophrenia patients after they have been stabilised on shorter-acting drugs, and after an induction dose is delivered once a month.
Aside from the direct risk of harm from a unregulated produce of dubious quality, administering a counterfeit raises the risk that a patient will see a return of their psychosis.
Earlier this week, BfArM also reported it had discovered falsified batches of Sandoz' human growth hormone product Omnitrope in the supply chain.