EMA warns Herceptin vials stolen in Italy spreading through EU


Vials of Roche's cancer med Herceptin that were stolen in Italy are now showing up in other places in Europe, leading the European Medicines Agency (EMA) to issue an alert and Herceptin maker Roche to recall all of the batches from which the stolen drugs came.

The EMA says so far none of the stolen vials have been found in hospitals and there have been no reports that any patients have been harmed. It says Italian authorities are investigating. The EMA said some of the vials were stolen from hospitals in Italy. It did not indicate how much of the drug was stolen, but 9 batch numbers were listed by the agency.

Roche ($RHHBY) told Reuters that counterfeit Herceptin has been discovered in Britain, Finland and Germany. Testing found some of the vials, which come with falsified records, did not contain the injectable cancer drugs' active ingredient. Others had it but showed signs of tampering or dilution. "Such tampering could compromise the sterility or efficacy of the product putting the health and wellbeing of patients at risk," Roche said in a statement.

The EMA told healthcare professionals that the falsified vials are labeled as Italian Herceptin® 150 mg. It said that batch numbers and expiry dates on most vials do not match those on the outer package. Some of the packages of powder have liquid in them and "evidence of tampering with the rubber stoppers, crimping caps or lids" was visible on some.

Counterfeit and unapproved drugs have become an increasing problem in the U.S. and Europe. Last year, a counterfeit version of Allergan's ($AGN) cosmetic drug Botox was found in the U.S. In 2012, the FDA found fraudulent versions of Roche's cancer treatment Avastin had been sold to physician practices throughout the U.S. The FDA and Department of Justice also have been prosecuting a number of cases in which versions of drugs manufactured for foreign markets but unapproved in the U.S. have been sold to American physician practices--including some of Roche's cancer meds. In some cases doctors knowingly bought the unapproved products because of the deep discounts offered on them, and the feds have charged some of them.

In an effort to better protect the U.S. supply chain, Congress last year approved a new law that over time requires the creation of national track and trace system. Under the new law, drugmakers are required to begin tracking prescription drug lots in 2015. Two years later, industry players must begin assigning serial numbers to individual "saleable units" of every prescription product sold in the U.S., government deadlines mandate. Some other countries also have similar requirements and drugmakers are responding. Eli Lilly ($LLY), for example, is investing $110 million into stamping unique codes and serial numbers on every drug package it sells worldwide to help protect against fakes.

- here's the release
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