Glaxo Wellcome to tighten monitoring of lead HIV drug

Click to follow
The Independent Online

Glaxo Wellcome, the drugs group, is to tighten its monitoring of prescriptions of its lead HIV drug, Ziagen, after it emerged that doctors had fatally given it to patients who had previously suffered an adverse reaction to the treatment.

Glaxo Wellcome, the drugs group, is to tighten its monitoring of prescriptions of its lead HIV drug, Ziagen, after it emerged that doctors had fatally given it to patients who had previously suffered an adverse reaction to the treatment.

Since its launch, doctors have been told not to re-prescribe Ziagen to patients who suffer hypersenstive reactions. The reactions are usually in the form of a fever or flu and can lead to death in Aids sufferers due to the weakness of their immune systems.

Glaxo said yesterday that the treatment had caused hypertensive reactions in 2 out of every 10,000 patients since its launch in the US in January last year. The treatment was launched in July in the UK.

The vast majority of doctors treating Aids patients have observed Glaxo's warning, but Glaxo is concerned that the message has been forgotten by doctors who do not specialise in treating HIV.

A Glaxo spokesman said yesterday: "Ziagen is a very potent drug, and when patients have an adverse reaction to it they must come off it. That's the critical message we must get across.We have done extensive consulation on Ziagen. The HIV community has known about [the risks] for some time. The real issue is that people working day in day out in HIV know about this, but doctors who are less involved need reminding."

The reported rate of fatalities involving Ziagen, at 0.02 per cent, is lower than the rate of adverse reactions to penicillin, which is 0.7 per cent.

In clinical trials, 4 per cent of patients tested were found to have died from hypersensivity while being treated with Ziagen.

HIV is Glaxo's second-largest franchise, and the group occupies more than one-third of the HIV treatment market. Ziagen generated sales of £73m in the first six month of this year.

Glaxo is still finalising its merger with SmithKline Beecham, another UK drugs giant. The deal, which will create the world's largest drug company, is expected to be completed on 25 September.

Comments