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US Sounds Alarm On Three New India-Made Diabetes Drugs

All the three type-2 diabetes medicines – canagliflozin, dapagliflozin, and empagliflozin – have been available in countries like the US and Europe since around 2012-13. The drugs may cause high levels of blood acids which can lead to serious adverse effects.

NEW DELHI – Three new type-2 diabetes medicines, two of which were recently launched in India, have come under the scanner of the US drug regulator for potential risk of causing acidosis that could require hospitalization.

The US Food and Drug Administration (FDA) has warned medical professionals and patients that type-2 diabetes medicines – canagliflozin, dapagliflozin, and empagliflozin – may cause high levels of blood acids which can lead to serious adverse effects.

The three drugs, all belonging to a new class known as SGLT2 inhibitors, work by lowering blood sugar by making the kidneys remove sugar from the body through the urine. The other existing medicines for type-2 diabetes do not work through kidneys and rather use pancreas as a pathway.

Though the US FDA has not yet banned the medicines, it has asked doctors to evaluate for the presence of acidosis, and patients to keep a close watch for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty in breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness.

“FDA is continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors,” the US drug regulator said in an alert issued last week. It, however, advised patients to not stop or change diabetes medicines without consulting the prescriber.

While canagliflozin and dapagliflozin were launched in India recently, adverse effects have not been observed or reported here so far. Doctors say though patients have been taking these medicines in India, it is too early to get surveillance data.

“These are promising medicines and we have been prescribing them. However, after the FDA alert, we will keep a close watch on how patients are behaving after using these medicines,” said Dr Anoop Misra, a leading endocrinologist and chairman of Fortis-CDOC for diabetes and allied sciences.

According to Misra, it is surprising how these medicines are likely to impact pancreas even as they do not work through that route and instead use kidney as the pathway. “The major positive of these medicines is that these are independent of action of body insulin,” he said.

The US FDA said its Adverse Event Reporting System database identified 20 cases of acidosis reported as diabetic ketoacidosis or ketosis in patients treated with SGLT2 inhibitors between March 2013 to June 6, 2014. It said all the affected patients required emergency visits or hospitalization to treat the condition. It had continued to receive adverse event reports of diabetic ketoacidosis and ketoacidosis in patients treated with SGLT2 inhibitors.

All the three drugs have been available in developed countries like the US and Europe since around 2012-13. While clinical trials were conducted for the drugs around the globe prior to their approval, it is one of the rare instances when the regulator has issued warnings in such a short span after the launch of the drugs in the market.

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