The debate surrounding the commonly prescribed drugs Rosiglitazone (also know as Avandia) and Pioglitazone (also known as Actos) reached a new high today as scientists called on the National Institute for Health and Clinical Excellence (NICE) to review their decision to recommend the drugs.
Both Rosiglitazone and Pioglitazone belong to a class of drugs known as "Thiazolinediones", which are used for the treatment of Type II diabetes mellitus. The drugs lower blood glucose levels primarily by increasing the patient's insulin sensitivity.
Dr Loke, a clinical pharmacologist at the University of East Anglia, who has reviewed data from 78,000 patients taking the drug with US colleagues, is quoted in the Guardian today as saying, "most patients in the studies did not have heart failure prior to starting on treatment with these drugs. There does not seem to be a group of patients who are safe from these side effects".
In a study published in the journal Diabetes Care in May this year, Dr Loke and his colleagues concluded that, even taking into account the pre-existing increased risk of heart attacks in patients suffering from diabetes, the risk doubled in patients on Thiazolinedione medication.
Increase in heart failure rates
The authors suggest that the reason for the increase in heart failure rates is that plasma volume is increased as a result of taking the drugs. They also comment that fluid retention due to the drugs may trigger episodes of heart failure in susceptible individuals or may "unveil" the disease in those with no previous cardiac history. Worryingly, they also note that heart failure occured at both high and low doses, usually within weeks to months of taking the drug.
Rosiglitazone was approved for use in the EU in July 2000 and the package insert warns patients with some forms of heart failure against use of the drug. It also cautions about the increased risk of heart failure in combination with insulin. Similarly Pioglitazone was licensed for use in the EU in October 2000. The package insert also warns about the increased risk of heart failure.
Use of the drugs, which are recommended by the National Institute for Health and Clinical Excellence, has doubled in the past 3 years.
A special meeting of the US regulator, the Food and Drug Administration, is scheduled for Monday. It is expected that they will discuss the safety of the drugs, which are taken by 7 million people in the US and several hundred thousand people in the UK.
The manufacturers of the drugs, Takeda and GlaxoSmithKline, deny the problems.If you have been affected by these, or other medical products and need expert legal advice, please contact Gene Matthews or Sapna Malik at Leigh Day & Co on 0207 650 1222.
ไม่มีความคิดเห็น:
แสดงความคิดเห็น