Last month we got concerned about the adverse effects of GLP-1 based diabetes drugs on the pancreas. The BMJ published an article suggesting that the link between the GLP-1 based diabetes drugs and pancreatitis and pancreatic cancer had been underplayed. The UK's Channel 4 then ran a Dispatches documentary on the issue. UK tabloids published headlines like "Is diabetes super drug a cancer risk for two million people?". And we were left to ask: âHave regulators been slow to react?'
Now the European regulator has reacted, and it seems that the concerns of last month were unfounded. In a review of GLP-1-based diabetes therapies by the EMA's Committee for Medicinal Products for Human Use (CHMP), the committee concluded that “presently available data do not confirm recent concerns over an increased risk of pancreatic adverse events with these medicines.”
Reviewing the study which pointed towards a risk of pancreatitis and pancreatic-duct metaplasia with the drugs, the CHMP found "a number of methodological limitations and potential sources of bias" in the study which precluded "a meaningful interpretation of the results."
The CHMP continues in its statement to say that while a number of cases of pancreatitis have been reported, these cases need to be interpreted cautiously. As for pancreatic cancer, the CHMP says that "data from clinical trials do not indicate an increased risk with these medicines," although "the number of events is too small to draw final conclusions.”
While the latest EMA statement doesn't by any means close the case on the matter, it will no doubt come as a relief to the drug manufacturers and an even bigger relief to the patients who take these drugs.
Read the statement from the EMA >
If you want to know more about drug safety and addressing the key challenges for safety professionals, you might be interested in attending the World Drug Safety Congress Europe 2013, 10-12 September 2013, London.
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