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FDA to Act Tough on Diabetes Drugs

The government has suggested for tougher standards to be set on diabetes related drugs. This change could mean that the manufacturers would have to spend a lot more money on meeting these standards but at the same time it would safeguard the interest of the millions of patients who might otherwise fall prey to heart related diseases. A panel which conducted the study came to the conclusion that the drug manufacturers would have to pass their drugs through various other studies to ascertain the fact that they are absolutely safe and will not have any side effects such as heart problem. At present no such studies are being undertaken by diabetes drug manufacturers to give a clean chit to the drugs regarding heart problems.

This new recommendation has come on the basis of a commonly used diabetes drug of GlaxoSmithKline. The drug had got approval from the FDA way back in 1999 but there was no warning on the label regarding heart risks related to the drug. With a lot of criticism from all quarters the warning had been put up only in November of 2007. The panel was of the opinion that the drug manufacturers should conduct various tests on the drugs before submitting it to the FDA for approval. The studies could end once the drugs are out in the market for sale. All these tests would take about 5 to 7 years to complete and would also cost the company millions.

There was also another school of thought in the panel which was of the view that even though the studies take so long the risk of heart disease could not be ruled out completely and at the same time breakthroughs in the field of medicine could be delayed. They were of the view that when so much time goes into the drugs coming out into the market then precious time would be lost in making better drugs being made available in the market. As per rules the FDA is not bound to follow all the recommendations and advice laid down by the panel but in most cases it does follow their advice. The leading producers of diabetes drugs are GlaxoSmithKline PLC, Takeda Pharmaceutical and Amylin Pharmaceutical. The drugs of these companies are the largest selling diabetes drugs in the country and with 24 million Americans having diabetes, the fear of developing complications due to the drugs are high.


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