Glaxo Wellcome to remove troglitazone

08 December 1997 00:00  [Source: ICB]

Glaxo Wellcome and Sankyo are set to withdraw the diabetes drug troglitazone from UK markets following reports of serious liver-related problems. The first of a new class of oral anti-diabetics, the drug - known as Romozin in the UK - has been marketed under licence from Sankyo since October.

The suspension followed more than 130 US and Japanese reports of serious side-effects of liver toxicity. At least six patients have died to date, and according to the UK Medicines Control Agency (MCA): 'This may well be a substantial under-reporting' of the drug's true toxicity.

The MCA now says that troglitazone is too risky to continue being prescribed to patients.

GW has also suspended all further applications for approval of the drug, including one for a European Community-wide licence, as well as in Israel and South Africa.

The loss of the European market could cost GW its projected Romozin revenues of up to £300m ($450m)/year. However, it has not given up hope: 'We will review the data and decide whether to resume it,' a spokesman for the company said.

Despite the caution of GW and the MCA, the US Food and Drug Administration (FDA) has not suspended troglitazone in the US where Warner-Lambert sells it as Rezulin. About 600 000 US patients have taken it since its launch in March.

Annualised sales by the third quarter of this year were running at $560m, making it one of the fastest-growing drugs ever. Warnings will now be included on the drug's packaging both in the US and in Japan where Sankyo sells the drug as Noscal.

Warner-Lambert was surprised at GW's decision, which it said was 'temporary'. It claims that the drug's risk-benefit ratio is still favourable. However, the need for patients to be regularly tested for toxicity will make the drug less cost-effective, and Warner-Lambert's shares fell 17% following the announcement. It must now 'assess the effect of the news on its 1998 sales earnings, but remains committed to superior earnings growth through the rest of the decade'.

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