KEY POINTS:
Health authorities are considering whether to ban imports of an antibiotic medicine widely used in New Zealand.
The United States Food and Drug Administration yesterday banned imports of two formulations of amoxicillin syrup and several other drugs made at two plants in India, owned by the company Ranbaxy, because of unresolved concerns from an audit in March. It has not banned sales of existing stocks in the US.
The New Zealand Ministry of Health's chief adviser on public health, Dr Ashley Bloomfield, said this afternoon that it had begun the process to ban imports of the drugs. But it would not make a decision on whether to proceed with a ban until considering further information, such as the results of any more recent audits done by other countries' medicines regulators.
There was no evidence that the drugs had caused any harm or were ineffective.
The FDA's concerns involved alleged breaches of "good manufacturing practice". One of the issues was a lack of proper records, which might have created a situation where cross-contamination of medicines could have occurred, but tests had not revealed any actual cross contamination.
Dr Bloomfield said that people who had been prescribed the drugs should continue taking them. If they had any concerns, the should call Healthline on 0800 611 116 or speak to their doctor.
New Zealand has 12 drugs that come from either of the two affected Ranbaxy sites, but only three are funded by Pharmac and therefore frequently prescribed. They are the anti-viral Lovir (aciclovir) 200mg, 400mg and 800mg tablets, for which around 60,000 prescriptions are written a year; anti-bacterial Cefaclor 250mg capsules and 125mg/5ml suspension (around 160,000 prescriptions a year); and anti-bacterial Amoxicillin 125mg/5 ml and 250mg/5 ml suspension (around 400,000 prescriptions a year).
