A major report of serious adverse events (SAEs) shows a 21-fold increase in reports of pancreatitis among patients with type 2 diabetes taking oral incretins, compared with those taking sulfonylureas or metformin.
The US review also shows a nearly 30-fold increase in reports of pancreatitis among people using an injectable incretin, compared with those taking sulfonylureas or metformin.
The findings come after the recent launch of a European Medicines and Healthcare Agency (EMA) investigation into reports of increased pancreatitis in people using incretins and of pathology findings of precancerous pancreatic changes.
US experts reviewed Food and Drug Administration SAE reports for five incretins for a one-year period from 1 July 2011 to 30 June 2012 and compared them with the combined SAE reports for three second-generation sulfonylureas and metformin in a population with type 2 diabetes.
They found a 26-fold increased number of reports of pancreatic cancer among incretin users, with a total of 105 cases reported for the five incretins overall.
The researchers wrote: ‘These results add additional scientific weight to the association of all five GLP-1 agents with reports of pancreatitis. However, the marked association in adverse event data does not indicate how frequently this adverse event might occur.
Comment by Pulse regular Vince Ho.
"Really another story of new drugs arriving with all kinds of promises and ended with serious concerns in adverse reactions. We read the same script over and over. Rofecoxib , sibutramine , rosiglitazone and now incretin analogue ( also gliptins then). Pharmaceutical companies cannot deny their responsibilities of pushing their new drugs too fast forward without full assessment of risk information , particularly on life threatening side effects."
Our team could not agree more.
Eddie
Link to article here.
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3 comments:
Very up to date information which once again this highlights the need for correct risk assessment.
Joe
This does give serious cause for concern. I know metformin does not suit all but I have found it very good in the help with my diabetes. A reduced carbohydrate and increased fat intake in my diet now has me with much greater control. Any new drug, injection, medication should be adequately tested.
Paul B
Recommended read
Jeff
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