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FDA tells patients to stick to diabetes drug linked to cancer,relief for millions in India

International studies published last week linked a very widely used synthetic insulin to increased risk of cancer.

Written by Toufiq Rashid | New Delhi |
July 3, 2009 1:20:30 am

International studies published last week linked a very widely used synthetic insulin to increased risk of cancer. But millions of Indian diabetes patients who use the drug have reason to be relieved after the US Food and Drug Administration (FDA) — and other regulatory authorities across the world — have decided to review the safety of the drug but have urged patients not to stop treatment.

In a statement earlier this week,the FDA restrained from giving the drug a clean chit but allayed fears. “(The agency) is not concluding that there is no causal relationship between the drug product and emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing the product,” the FDA said. It is investigating the case.

India has a 45-million diabetic population and is considered to be the global epicentre of the disease. Insulin glargine is approved to control blood glucose in patients with Type 1 and Type 2 diabetes. According to doctors in India,the drug is used by at least 30 per cent of patients with Type I diabetes and by about 70 per cent with Type II.

Diabetics across the world were alarmed after the prestigious Diabetologia,the journal of the European Association for the Study of Diabetes (EASD),reported in its June 30 issue studies linking the drug to cancer risk. According to the EASD,analysis of 127,000 insulin-treated patients reported a statistically significant link between cancer and Insulin Glargine use compared with those using similar doses of human insulin. Among those receiving Glargine,there was an increase of 1 person with cancer for every 100 people receiving human insulin.

This study,conducted in Germany,also indicated a dose-dependent increase in cancer risk: 10 units of insulin glargine increased the risk by 9% whereas 50 units increased it by 31%. As a result of these findings,studies were also conducted in databases from Sweden,Scotland,and the United Kingdom. The Swedish study found that compared with patients on other forms of insulin,patients receiving Glargine alone had a two-fold increased risk for breast cancer. The Scottish study found a nonsignificant increased risk for breast cancer whereas the UK study found no link between insulin glargine and any type of cancer.

“The studies are conflicting and loose. Cancer is a multifactorial disease,one of the major reasons is obesity which makes diabetics more prone to the process. These are all observational studies and need more research,” said Anoop Misra,head of Diabetes and Metabolism at the Fortis Hospital in Delhi.

Others agree. “We get about 30 to 40 calls daily from panic-stricken patients. These are small observational studies. Doctors in India have given statements saying that they won’t stop prescribing the drugs. The drug does act on the growth-promoting cells but not substantial enough to cause cancer,” said S K Wangnoo,Senior Endocrinologist at Indraprastha Apollo Hospital,Delhi.

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