Medsafe halts Apotex medicine imports

Medsafe says it has temporarily stopped importing medicines produced by Canadian company Apotex.

The Ministry of Health's drug regulatory arm said the halt followed a similar move in the United States last week.

Apotex has also voluntarily recalled 40 medicines from the US market and three from the Canadian market.

No batches of the medicines recalled in the US and Canada are available in New Zealand, the ministry said today.

Patients did not need to stop taking medicine if it was made by Apotex and there was no indication that patients have experienced problems from using its medicines.

Medsafe group manager Stewart Jessamine said the temporary restriction on imports was a precautionary measure which would remain in place until Medsafe was satisfied that Apotex had improved its manufacturing practices.

"At this point, there is no reason for people to be concerned about taking any medicines manufactured by Apotex. There is no suggestion that people have been put at risk by taking any medicines made at any Apotex plants," Dr Jessamine said.

The issue that has been identified relates to the assurance of quality manufacture at the Canadian plants, he said.

Medsafe was working closely with Pharmac, New Zealand's pharmaceutical funding and purchasing agency, to identify which Apotex medicines are available in New Zealand.

Pharmac funds 30 medicines supplied by Apotex, of which 20 are made at the two Canadian factories concerned.

Pharmac medical director Peter Moodie said Apotex products were widely used in New Zealand.

"As a precaution, Pharmac has begun discussions with other companies to ensure that future supply requirements can be met in the event that the import restriction is required for longer than expected."

A list of all medicines manufactured at the two affected sites that have consent for distribution in New Zealand is available on the Medsafe website at: www.medsafe.govt.nz.

- NZPA