Vials of the cancer drug Herceptin probably stolen in Italy have been tampered with and reintroduced into the medicine supply chain, the European Medicines Agency said.
Counterfeit drugs have been identified in the U.K., Finland and Germany, Roche Holding AG, the Swiss maker of Herceptin, said in an e-mailed statement. There have been no reports of any harm to patients from the fakes, the EMA said in a separate statement today. Roche is recalling suspect vials as a precaution, the agency said.
Herceptin, used to treat breast cancer, is among Roche’s best-selling products, with sales of 6.1 billion Swiss francs ($6.9 billion) in 2013. An analysis of one of the stolen vials showed it doesn’t contain trastuzumab, the active ingredient in Herceptin, Roche said. Other vials were shown to have been diluted.
“This is the first time a product suspected of being counterfeited has entered the official drug distribution chain in Finland,” the Finnish Medicines Agency said in a statement on its website.
The EMA and Roche didn’t say how much of the drug was stolen, or where and when it was taken. The vials appear to have been stolen from nine batches, Roche said. The counterfeit vials are labeled Italian Herceptin 150 milligrams, and there is evidence of tampering with rubber stoppers, caps or lids, the EMA said. Tampering could compromise the sterility or the potency of the medication, Roche said.
Italian law enforcement authorities are investigating the theft and whether any other medicines might have been affected, the EMA said.
The counterfeiting was first discovered by a U.K. drug wholesaler that noticed discrepancies between lot numbers in the packaging of medicine purchased through an Italian wholesaler and intended for sale in Germany, AIFA, the Italian drug regulator, said in a statement.
Finland has prohibited the distribution of the imported Herceptin batches under suspicion and the hospitals that ordered the batches have been traced, the country’s drug regulator said. The drug isn’t delivered to patients from regular pharmacies, the Helsinki-based agency said.
One of the suspect batches hasn’t been distributed and is located at the drug wholesaler’s warehouse, the Finnish agency said. In this batch of 26 packages, three Herceptin packages were found to contain fluid, while the real drug is in powder format. The rubber plugs on the bottles were punctured. The unknown liquid was found in a laboratory test to contain a very small amount of trastuzumab compared with the genuine drug.
Roche didn’t import the suspect Herceptin batches into Finland, and the batches imported by Roche are available for patient treatment, the regulator said.