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FDA restricts diabetes drug Avandia trial

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FDA restricts diabetes drug Avandia trial

July 28, 2010 | Drug Companies

The Food and Drug Administration (FDA) has restricted GlaxoSmithKline (GSK) from enrolling new patients in a trial for the drug Avandia (rosiglitazone) after new information about the drug’s serious side effects came to light. Avandia is used to treat type 2 diabetes by controlling blood sugar levels, and can increase the risk of heart attack, a common cause of death in diabetics.

That in itself is not new information. In 2007, the FDA put a black box warning on Avandia when it became apparent through drug trials that the drug increased the risk of heart attack. A black box warning is the strongest warning that can be included in prescription drug package inserts, so named for the bold, black border that surrounds the information. It is used when a drug is found to cause severe or life-threatening adverse effects.

What is new is that GSK may have tainted initial studies in order to control published results. It’s possible GSK knew Avandia was much more dangerous than those trial results showed three years ago.

While the FDA investigates, it has prohibited the drug maker from accepting new patients into current trials. Participants in current trials are not affected by this restriction. On July 14, a 33-member FDA panel reviewing scientific data about Avandia voted on what action should be taken. Twelve panel members voted for Avandia to be taken off the market completely. But others were in favor of simply enhancing the black-box warning, and adding restrictions to the drug’s prescribed use. In short, The FDA has not yet come to a consensus on how to handle the situation.

In the meantime, if you or a loved one is taking Avandia, do not stop taking the drug on your own. This can cause blood sugar levels to become unstable, causing other serious health problems. Talk to your doctor to address your concerns, and perform any drug changes under the supervision of a medical professional.

If the worst has occurred, and you or a family member taking Avandia has suffered a heart attack or other serious side effects related to the drug, you need representation from an Avandia lawyer in Colorado. An attorney can help you determine how to proceed when dealing with this large, possibly dishonest pharmaceutical company.

 

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