Roche to check Herceptin vials after cracks found

Last Updated: 2006-11-22 14:03:09 -0400 (Reuters Health)

LONDON (Reuters) - The European Medicines Agency (EMA) said on Wednesday drugmaker Roche had agreed to inspect vials of breast cancer drug Herceptin after some were found to be cracked.

The watchdog said the cracks, caused by a fault in the packaging process, could lead to a loss in sterility, which could cause infections in patients.

It said the aim of the plan agreed with Roche was to identify and remove defective vials while maintaining supply of the drug, so patients do not have to interrupt treatment.

Roche had received about 20 complaints of cracked containers from hospitals in France, Germany, Ireland and Britain, EMA said, adding the drugmaker had already inspected 13,000 packaged vials, finding a cracked bottleneck in 1 in 1,000.

"While testing indicates that the cracks have no effect on the sterility of the product, the company has been advised as a precautionary measure to re-inspect the vials and replace the cracked vials," EMA said.

"Only vials packaged since March 2006 are affected by the defect."

EMA said Roche had provided instructions to every hospital and treatment centre where Herceptin was used and was committed to insuring that each hospital reported back its findings.

Herceptin, given by injection, is an antibody-based drug designed to target tumour cells and spare normal cells, unlike chemotherapy, which is toxic throughout the body.

Roche could not immediately be reached for comment.