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More evidence suggests diabetes drug may be dangerous
Date:12/11/2007

umbers of people received the other drug pioglitazone

(Actos), limiting our ability to be certain about adverse events in

this group.

Co-author and Senior ICES Scientist, Dr. David Alter says, "We don't want people to panic. Treatment decisions must remain individualized with doctors and patients weighing the potential harms and benefits of these drugs, especially when used among the elderly who are at higher-risk of cardiac complications."

The Ontario based ICES study comes on the heels of the Food and Drug Administration (FDA) slapping a prominent black box label warning on the popular diabetes drug Avandia telling patients that it may, or may not, increase the risk of heart attacks. It is the most severe type of warning the agency can require pending further research. Glaxo Smith Kline, Avandia's manufacturer has agreed to do a longer term study comparing the drug to other medications, but those results won't be available for another six years. Since the drug's approval in 1999, more than 7 million people worldwide have taken Avandia, designed to increase the body's sensitivity to insulin, generating sales worth $3 billion annually.

"Our study demonstrates the importance of post-marketing surveillance of new drugs. Manufacturers are often required to only demonstrate diabetes medications lower blood sugar not that they prevent long term consequences of diabetes. Research trials are often insufficient to detect less common adverse effects of drugs, so ongoing safety monitoring of drug side effects in larger real-world populations is vital. Experts from regulatory bodies such as Health Canada and the Food and Drug Administration will have to consider our findings in the context of all the evidence so far, to decide the future of these drugs," says Dr. Lipscombe.

The study 'Thiazolidinediones and Cardiovascular Outcomes in Older Patients with Diabetes' is in the December issue of JAMA.

Author affiliations: ICES (
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SOURCE Institute for Clinical Evaluative Sciences
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