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EMA warns on stolen Herceptin

Says vials of cancer drug have been tampered with and re-introduced into supply chain
Roche Herceptin trastuzumab cancer

Batches of the cancer drug Herceptin have been stolen and reintroduced illegally into the supply chain, according to European authorities.

The European Medicines Agency (EMA) last week told healthcare professionals to be on alert after some vials of Roche's Herceptin (trastuzumab) had been stolen in Italy and given false credentials after being tampered with.

The theft, which includes drugs stolen from hospitals, is being investigated by Italian authorities, although the EMA said that the situation goes beyond EU and current national practices for handling medicine defects.

“These are extraordinary circumstances driven by criminal activities that require special measures and strong collaboration from authorities across the EU,” said the agency.

The EMA also confirmed that vials of two other drugs had been taken as part of the theft. These are Lilly's cancer drug Alimta (pemetrexed) and Janssen's Remicade (infliximab), which is approved for rheumatoid arthritis and several other autoimmune conditions.

However, unlike Herceptin there has been no evidence that any of the stolen vials of Alimta or Remicade have been tampered with or been distributed.

Despite the seriousness of the issue, the EMA confirmed that only a small numbers of Herpcetin vials are thought to be affected and there have been no reports of a patient being harmed in relation to the falsified medicines.

Nevertheless, HCPs have been told to be on the look out for signs such as batch numbers and expiry dates on the vials not matching the outer package and a liquid being present in vials of Herceptin, which comes as a powder.

Several measures are in place to deal with affected vials of stolen drugs, including an EU-wide recall of suspected batches and temporary national procedures, including quarantine of suspected products or restriction of parallel distribution.

The EMA said it does not expect these measures will result in a shortage of medicines.

Article by
Thomas Meek

22nd April 2014

From: Sales, Regulatory, Healthcare



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