By Marta Falconi
ZURICH--Europe's top medicine authority warned Wednesday that
stolen vials of a Roche Holding AG cancer drug have been
reintroduced in some parts of Europe, raising the prospect patients
may receive tainted treatments.
The London-based European Medicines Agency said vials of
Herceptin, a biologic treatment for breast and stomach cancer, were
likely tampered with after a suspected theft of the drug in Italy.
Tampered vials have since been found at the wholesale level in the
U.K., Germany and Finland, the EMA said.
The EMA said it had received no reports of affected vials
reaching the hospital level or reports of patients being harmed.
The agency said it didn't expect any shortage of the drug because
of the issue.
Roche said in a statement it was aware that counterfeit
Herceptin vials had been identified and is working with authorities
to recall the batches. The company said there was evidence of
tampering or dilution in some batches and that some vials didn't
contain the active ingredient.
Italian authorities are investigating the suspected theft and
are looking at whether other medicines may also be affected.
Herceptin, or trastuzumab, is used to treat patients with breast
cancer and metastatic stomach cancer. Mainly used in hospitals, the
drug is available as a powder to be made up into a solution for
intravenous infusion or subcutaneous injection.
The EMA said only the intravenous formulation seems to be
affected.
Write to Marta Falconi at marta.falconi@wsj.com
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