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Diabetes drugs must go through longer studies to make it certain that they are free from unexpected heart risks; this has been recommended by a government panel. It may cost pharmaceutical companies millions but it is protective for the patients to avoid unexpected heart risks.
On Wednesday, with a 14-2 voting, the advisers of the Food and Drug Administration recommended that all new diabetes drugs must have undergone longer studies to make it certain that they didn’t boost cardiovascular problems risks.
The diabetes experts, cardiologists and statisticians opined for less than a year after the FDA was badly criticized regarding managing the issue of GlaxoSmithKline’s commonly used pill. The drug was recommended in 1999 but FDA didn’t warn about possible heart risks till last November.
Many members of the panel suggested that drug companies should start safety tests before submitting any drug to the FDA, and they also complete the studies after the availability of the drugs in the market. The testing would cost tens of millions of dollars to the drug manufactures and will take a time of five to seven years to complete.
According to Dr. Eric Felner who is a pediatric specialist at Emroy University School of Medicine, “If such amount of time is spent for testing, it will be certainly preventing some drugs that may prove better than the already available drugs.”
It is not essential for FDA to follow the advice of the panel but it often does. Almost 24 million Americans are the victim of Type 2 diabetes that can cause kidney failure, blindness and heart disease.
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