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Home Industry News GSK Ziagen claim cannot be definitively concluded, says EMEA

GSK Ziagen claim cannot be definitively concluded, says EMEA

3rd April 2008

The European Medicines Agency (EMEA) has said that the available data from a recent study into GlaxoSmithKline’s (GSK) Ziagen (abacavir) does not definitively conclude a link between the product and increased risk of heart attack.

Recent research published this week in medical journal the Lancet claimed that use of abacavir could be associated with an increased risk of myocardial infarction.

The D:A:D study, commenced in 1999, includes over 33,000 people suffering from HIV. Ziagen works as an anti-retroviral product to keep the Aids virus at bay.

But following the research, the EMEA’s Committee for Medicinal Products for Human Use (CHMP) said no changes would be made to the prescribing information for Ziagen, although further data would be needed.

The CHMP added that it has requested further information from ongoing epidemiological studies.

In the UK, Ziagen is manufactured as 300mg film-coated tablets and as an oral solution.

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