Medsafe decision is simply depressing

Medsafe has ignored worldwide calls for a highly controversial and potentially dangerous anti-depressant drug to be withdrawn from the market and instead has allowed its continued sale to New Zealanders, Green MP Sue Kedgley said today.

Ms Kedgley, the Green Health spokesperson, urged Medsafe to immediately withdraw Serzone, prescribed for moderate to serious depression, from the market because of a demonstrated link to liver failure and death.

"The evidence is mounting that this is a drug with potentially fatal side-effects and that we have very little need for it in New Zealand," said Ms Kedgley.

"Since February 2000 we are aware of 14 cases of hepatic (liver) illnesses - seven of liver injury and five cases of abnormal liver function - in patients who are prescribed Serzone in New Zealand.

"I want answers from Medsafe and the Minister of Health as to why it is taking so long for this drug to be removed from the market, when serious risk of liver damage from the drug have been know for years.

"There are other drugs available for depression treatment, so why keep this drug on the market?" she asked.

"It seems odd that we went into overdrive and withdrew hundreds of complimentary health products over a minor over-the counter travel medicine but when it comes to a pharmaceutical with significant side effects the Government is dragging its feet."

Reports of liver injury of which the drug is a factor have increased steadily around the world. Serzone has been removed from the European and Canadian markets and there have been calls in both Australia and the United States for the drug to be banned.

A national class-action lawsuit was launched on behalf of Canadians who have become ill or died as a result of taking Serzone, and similar actions have developed in Australian and the US.

"The rate of liver failure that leads either to death or the need for a transplant is about four times higher than normal according the US Federal Drug Administration, whose concern was so great they now require a warning of 'life-threatening liver failure' on each packet of Serzone," said Ms Kedgley.

"The reports of liver failure, while not numerous, are hugely concerning. Medical safety information lists potential problems ranging from a severely inflamed liver and jaundice and can lead to kidney and brain degeneration, while death or the need for a transplant can arrive between two weeks and six months after beginning Serzone therapy."

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