EMA Warns Of Stolen And Tampered Herceptin Vials

The European Medicines Agency has alerted healthcare professionals in the EU after identifying falsified Herceptin (trastuzumab) vials. Herceptin is Roche’s breast cancer drug containing the active drug trastuzumab.

“The European Medicines Agency (EMA) has been informed that vials of the cancer medicine Herceptin (trastuzumab), thought to have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the supply chain in some countries. This is currently being investigated by Member State authorities and updates will be provided as more information becomes available. Italian law enforcement authorities are currently investigating the theft and are looking at whether other medicines may also be affected,” the agency stated in a press release.

The counterfeit Herceptin vials contained no trastuzumab. In other cases, the vials contained diluted Herceptin, pointing to possible tampering. Roche said such tampering could compromise the drug’s stability and efficacy.

Herceptin is an anticancer drug used to treat patients with breast cancer as well as metastatic gastric or stomach cancer. The drug was approved in the EU in August 2000.

Roche said that counterfeit Herceptin units have been reported in Britain, Germany, and Finland. The company is recalling all suspected vials as a precautionary measure. The EMA identified known affected Herceptin batches as H4311B07, H4329B01, H4284B04, H4319B02, H4324B03, H4196B01, H4271B01, H4301B09, and H4303B01.

Patients who have any concerns regarding suspect Herceptin units are encouraged to report to their physicians. However, no reports of adverse events have been received yet. “The EMA is coordinating the response by the appropriate health authorities in the Member States. Although all information is not yet available, it is not expected that this will result in shortage of medicines for cancer patients… The EMA is monitoring the situation closely and will provide updates as appropriate,” stated the agency.

Counterfeiters have targeted Roche’s drugs in the past. Fake copies of the company’s cancer drug Avastin were discovered in 2012.