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</td><td height="1" valign="top"> <!-- start I relate to widget --> <!-- end I relate to widget --> Q&A: diabetes drug risk

All thanks to the Guardian in UK And David Batty


David Batty
Friday July 27, 2007
Guardian Unlimited

What is the concern about?

A study of two of the drugs most commonly used to treat diabetes suggests that they almost double the risk of heart failure. The research, published in the journal Diabetes Care, is likely to cause considerable concern in the UK with around half a million patients taking the drugs. The researchers have called on the National Institute for Health and Clinical Excellence (Nice), the drugs and treatments watchdog for England and Wales, to review its guidance on the drugs, which recommends that they should be provided on the NHS.

<!-- This site/section combo is not set up to show MPU's -->Which two drugs are involved?

The drugs concerned are Avandia (rosiglitazone), manufactured by GlaxoSmithKline, and Actos (pioglitazone), produced by Takeda, which are used to treat type II diabetes. In this type of diabetes the body does not make enough of the hormone insulin, or the cells in the body do not react properly to the hormone. The drugs, which sensitise the body to insulin and lower blood sugar levels, were hailed as a major advance in the fight against the disease.

What are the latest concerns?

The research shows that up to one in every 50 patients taking the drugs over a period of 26 months will need to be hospitalised for heart failure. This implies that an estimated 10,000 patients in the UK are at risk.

The researchers, from the University of East Anglia and Wake Forest University in North Carolina, studied data on 78,000 patients who had taken Avandia and Actos. They found the drugs could cause fluid retention in the lungs, leading to heart failure. Dr Yoon Loke, a clinical pharmacologist at UEA, said most patients in his research did not have heart failure prior to taking the drugs. He said: "This means that the diabetes drugs could have caused thousands of additional cases of heart failure, creating a substantial burden on hard-pressed NHS services."
The study follows an earlier warning about Avandia, published in the New England Journal of Medicine in May, which linked the drug to a 43&#37; increased risk of a heart attack. GlaxoSmithKline strongly contested that study's findings, which led to a 22% decline in global sales.

What do the drug manufacturers say?

Alistair Benbow, European medical director for GlaxoSmithKline, said it was "well recognised" that this class of drug could cause fluid retention and the risk was "clearly stated" on its medication. He added that this could be resolved if the patient was well monitored and prescribed diuretics - drugs that prevent water retention by promoting more frequent urination. Takeda, which makes Actos, declined to comment.

What do healthcare regulators say?

The Medicines and Healthcare products Regulatory Agency currently states that the drugs are a safe and effective treatment for type II diabetes. Both the MHRA and the European Medicines Agency, which licensed the drugs, said that people should not stop taking the drugs and if concerned they should consult their doctor. Nice said it would take into account any new information when it updated its guidance on diabetes in February, but that any decision to limit prescribing of the drug rested with the EMEA.

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