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FDA warning puts doctors on alert on diabetes drug

A commonly used drug to treat Type II diabetes,Byetta,has come under the scanner of the US Food and Drug Administration....

A commonly used drug to treat Type II diabetes,Byetta,has come under the scanner of the US Food and Drug Administration (FDA),which says that it causes kidney problems including kidney failure in patients.

Byetta is usually recommended in cases where blood sugar levels and obesity both are unmanageable. Indian doctors say while the observations of kidney getting affected after using Byetta are rare in their practice,they would be cautious and tell their patients to be alert from now on.

“Byetta (exenatide) remains a useful new drug for diabetes,especially in obese patients,in whom it leads to weight loss and better sugar control. These new observations of kidneys getting affected must be rare in India. However,since this drug may lead to nausea,vomiting,and thus lead to decreased fluid intake,it may cause deterioration of kidney function in those with pre-existing kidney problems,” said Dr Anoop Misra,Head,Department of Diabetes & Metabolic Diseases,Fortis Hospitals.

The drug has been in use in India for the past two or three years. Those who have been recommended Byetta have to get two doses injected every day. Although private doctors commonly recommend the drug,those in government hospitals rarely do so as the drug is highly priced. “Byetta is one of the agents which is not as important as insulin and is hardly recommended for the set of people examined here due to its high price,” said a doctor from the All India Institute of Medical Sciences.

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According to Dr S K Wangoo,Senior Consultant,Endocrinology at the Apollo Hospital,who recommends Byetta to almost 10 per cent of his patients,he has never seen a problem with the drug. But the caution of FDA cannot be ignored,he added. “This cannot be applicable to all patients. We have been recommending it for long and never faced such a problem,” he said.

The FDA on the other hand received about 78 reports of problems in kidney function in patients using this drug between April 2005 and October 2008. “While in some cases,the problems occurred in patients with pre-existing kidney disease,many of those with one or more risk factors developed it,” the FDA said.

Among these cases,hospitalisation was required in 71 patients and there were four deaths reported in the cases reviewed. Eighteen patients required dialysis and two patients required kidney transplantation.


As per the FDA,in cases where Byetta was discontinued,patients reported signs of improvement. “One patient experienced recurrent altered kidney function after re-initiation of Byetta,” it said. The FDA,therefore,advised doctors and patients taking Byetta to “pay attention to signs and symptoms of kidney problems.”

First published on: 05-11-2009 at 03:40:43 am
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