Distribution of Rezulin Under Review

22 March 2000

Distribution of Rezulin Under Review

DISTRIBUTION of the diabetes medicine, Rezulin is now under review in New Zealand, following recent concerns the drug may cause toxic liver damage.

Rezulin was approved for distribution in New Zealand in January, but has not yet been sold or marketed in this country. It has however, been supplied to 12 patients - 10 under clinical trials and two at the special request of their doctor.

The manufacturers, Parke-Davis/Warner-Lambert today advised the Ministry of Health it would not proceed with distribution of the product in New Zealand, following the withdrawal of Rezulin from the US market. The manufacturer is also contacting the prescribers involved in New Zealand clinical trials to advise them of the withdrawal.

Senior Medical Advisor, Dr Stewart Jessamine says the Ministry will now be collecting information with a view to considering revoking the consent.

"As part of the approval process, the Ministry of Health had taken into account the fact that Rezulin's use elsewhere had been restricted after it was found to cause liver damage in some patients.

"The Medicines Assessment Advisory Committee will now be reviewing the data and on-going safety data which has subsequently been collected."

"Although it was recognised that Rezulin can cause liver damage, evidence at the time showed that this occurred in a small number of patients, (less than 0.5%) and the risk of serious liver damage occurring was significantly reduced by regular monitoring of blood tests of liver functions."

"The prescribing information for Rezulin stated a number of requirements for monitoring of liver tests in order to minimuse the risk to acceptable level."

Dr Jessamine said it is highly likely the clinical trials will be stopped immediately as a result of today's withdrawal.

ENDS

For more information contact: Selina Gentry, Media Advisor, ph: 04-496-2483 or 025-277-5411 Internet address: http://www.moh.govt.nz/media.html

BACKGROUND: The approval process for new medicines in New Zealand

If a company wishes to market a medicine in New Zealand, the legislation (Medicines Act 1981) requires that the company must obtain the consent of the Minister. The Medicines Assessment Advisory Committee (MAAC) is the Ministerial advisory committee which evaluates new medicines on behalf of the Minister. The MAAC consists of clinicians in a number of specialist fields. The MAAC meets four times a year.

The committee evaluates data submitted by the company which examines the safety, quality and efficacy (effectiveness) of the product. The applications are in a common format utilised by European medicines regulatory agencies. New Zealand applies the same standards for clinical trials and manufacturing processes to demonstrate safety, quality and efficacy as other OECD regulators, including the UK and EU. If the MAAC is satisfied that an application meets the required standards it makes a recommendation to the Minister that the product can be approved.

The MAAC may add conditions to this approval or require that changes to prescribing information or labelling are made before the product can be finally approved. In addition to completing any actions recommended by the Committee, Medsafe also evaluates labelling to ensure that it complies with the New Zealand regulatory requirements. It is only after a new medicine has been recommended for approval by the MAAC, and Medsafe has approved labelling and resolved any outstanding issues that the Minister grants approval for the product.

The Ministerial decision to grant consent for the distribution of a medicine is published in the New Zealand Gazette. The gazette is published weekly. As with many regulatory decisions, the Ministerial authority to accept recommendations from the MAAC and to approve medicines has been delegated to a Chief Advisor in the Ministry of Health.

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