FDA Medicare Alliance To Tackle Drug Side Effect Problems

Armen Hareyan's picture
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Starting from the next month Food and Drug Administration (FDA) and Medicare will cooperate on launching a new program, which will help in monitoring safety problems of drugs and medical devices that are already in the U.S. prescription drug market.

Medicare and FDA are going to provide their databases of medication side effects gathered from the manufacturers, which will help in creating early warning network.

The new system, called Sentinel will give the opportunity to monitor millions of people, including elderly, disabled and patients who have several types of chronic diseases. FDA was seriously criticized, after the "case of VIOXX," the painkiller, which was withdrawn from the market in 2004, after being used in U.S for several years, by the reason of increasing the risks of heart attacks and strokes.

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Often times the side effects of the prescription drugs are not completely revealed during the medical trials, because of the limited quantity of people being tested, meanwhile the side effects some times are revealed only after being used by millions of people, and it takes many years to identify the source of problems. So the Sentinel, as it is connected to the patients, will help to accelerate the process of revealing the side effects from couple of years to some months, and also will help to reduce the expenses.

There has been slight criticism regarding the new program, from drug companies' side, which was based on the idea that monitoring large quantity of people may trigger a false alarm on which Janet Woodcock, who heads the FDA center that reviews new drugs, acknowledged that possibility, but said the alternative was worse.

"We completely understand and agree that getting information in this way isn't as free of bias as what we get in a clinical trial," she said.

"However, in most cases, we don't have any way of getting this information at all right now."

She also mentioned that FDA

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