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Safety review for diabetes drug

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Medical experts are reviewing the safety of a widely used drug to treat diabetes after experts linked it to pancreatic cancer.

Researchers have suggested that there could be a link between incretin mimetics, which are used to treat type 2 diabetes by regulating blood sugar, and the disease.

Earlier this year, experts in Europe and America launched a review into the safety of the drugs.

The British Medical Journal (BMJ) said that US Food and Drug Administration (FDA) and the European Medicines Agency are meeting to discuss the matter later this month.

The review was launched after independent analysis of health insurance data found that people taking such drugs could be twice as likely to be admitted to hospital with pancreatitis compared with people taking other anti-diabetic drugs, the BMJ said.

And separate research from the US, published in April, suggested that there was an increase in reports of pancreatitis and pancreatic cancer in people taking the drugs.

In America, hundreds of people are suing manufacturers alleging that the drugs caused pancreatitis and in some cases cancer, according to an article in the journal.

The piece states: “The FDA and EMA have both confirmed to the BMJ that their own analyses also show increased reporting or signals of pancreatic cancer with incretin mimetics.

“But they emphasise that this does not mean the relation is causal.

“Both agencies announced in March that they will review data from a study just published showing pre-cancerous and dysplastic changes to the pancreas in organ donors exposed to incretin mimetics.”

Following a joint investigation with Channel 4’s Dispatches, which airs tonight at 8pm, the journal’s experts state that the safety concerns are “fiercely contested” by the manufacturers.

They claim that the companies have not done “critical safety studies”.

They were also critical about being denied access to raw data from the manufacturers own research which “would have helped resolve doubts about the safety of these drugs”, and have called on pharmaceutical companies to be “more transparent” with their data.

“On their own the individual pieces of unpublished evidence may seem inconclusive, but when considered alongside other emerging and long standing evidence, a worrying picture emerges, posing serious questions about the safety of this class of drug,” said the BMJ’s investigation editor Dr Deborah Cohen.

The journal’s editor in chief Dr Fiona Godlee added: “All drug licensing is about balancing benefits and risks.

“But instead of engaging in open debate about legitimate and important scientific questions, the manufacturers have been unwilling to share their data. Meanwhile patients and doctors have not been kept properly informed about the uncertainties surrounding these drugs.

“The debate would be much easier to resolve if all the information was placed in the public domain so scientists, doctors and ultimately patients could make up their own minds.”

But charity Diabetes UK said that patients should not stop taking their medication unless advised by their doctor.

Simon O’Neill, Diabetes UK director of health intelligence, said: “The European Medicines Agency is currently investigating findings from an independent study that has suggested there may be a link between use of GLP-1 and DPP-4 based therapies for type 2 diabetes and pancreatitis and pancreatic cancer.

“Diabetes UK does not currently advocate any change in the use of GLP-1s and DPP-4 based treatments for patients with type 2 diabetes and will await the findings of the European Medicines Agency research. In particular, patients should not stop their medication, unless advised by their doctor.”

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