Tuesday, June 21, 2011

Don’t discard diabetic drug Pioglitazone even after the FDA’s Safety Announcement

The U.S. Food and Drug Administration has announced that the use of the popular diabetic drug pioglitazone for more than one year may be associated with an increased risk of bladder cancer.
According to the FDA’s Safety Announcement, information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines.
However the Endocrine Society, American Association of Clinical Endocrinologists and American Diabetes Association inspite of the FDA announcement have urged diabetes patients not to panic and stop the drug without their doctor’s advice.  Stopping diabetic drug can result in higher levels of blood glucose that may cause serious short term health problems and could increase the risk of diabetes-related complications in the long term.
As per the advice all diabetics should adhere to the following guidance provided by the FDA:
1.       All diabetics should be told that there may be an increased chance of having bladder cancer when taking pioglitazone
2.        One should not take pioglitazone if receiving treatment for bladder cancer;
3.        One should consult right away if one has any of the symptoms of bladder cancer including blood or red color in urine; urgent need to urinate or pain while urinating; pain in back or lower abdomen;
According to the FDA Safety Announcement, the five-year interim analysis of an ongoing ten-year study showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients who had been on pioglitazone the longest and had been on higher doses over time.
Large number of diabetics are on pioglitazone which reduces insulin resistance and is useful in metabolic syndrome. The drug is already in criticism for gaining weight and possible heart failure.
About the author: Padmashri & Dr. B.C. Roy National Awardee, Dr. KK Aggarwal is a Senior Consultant, Physician, Cardiologist at Delhi based Moolchand Medcity; President Heart Care Foundation of India; Chairman Ethical Committee Delhi Medical Council and has served as the Research and Academic Wing Heads of National Indian Medical Association.

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