FDA Pulls Diabetes Drug Avandia from Drug Stores

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Instead, it will be available by mail order only from selected certified

pharmacies, and patients as well as physicians will have to undergo

educational programs before it can be prescribed, the agency said. The FDA

announced in September that it would take this action, but the new rules are

just now being implemented.

The blockbuster drug was introduced by GlaxoKline in 1999 and soon

became one of the most popular diabetes drugs because of its ability to

improve control of type 2 diabetes. By 2006, at least 1 million Americans

were taking the drug and annual sales had climbed to more than $3 billion

In 2007, however, Cleveland Clinic cardiologist Dr. Nissen published

a

study<http://www.diabetesincontrol.com/index.php?option=com_content & view-article\

& id=5128>showing

a 40% increase in the risk of cardiovascular disease, heart attack,

stroke and death among those taking it. In 2007, the FDA put a so-called

black box warning on the drug's label cautioning users

<http://www.diabetesincontrol.com/articles/diabetes-news/4882>about the

risks, and sales began falling. As of last October, only about 119,000 U.S.

patients were taking the drug, the agency said. Most patients who were using

it shifted to the related drug Actos, known generically as pioglitazone,

which is not believed to cause similar cardiovascular effects.

The new action, implemented under the agency's Risk Evaluation and

Mitigation Strategy, applies not only to Avandia, but also to Avandamet

(which contains rosiglitazone and metformin) and Avandaryl (a combination of

rosiglitazone and glimepiride). The drugs will be available only to patients

who are already successfully using them and whose diabetes cannot be

controlled with any other medication, or those who do not wish to take

pioglitazone. Physicians who wish to prescribe the drugs and patients who

wish to receive them must be enrolled in the Avandia-Rosiglitazone Medicines

Access Program. Physicians must certify that they have read and understood

the conditions for use of the drugs and agree to explain the risks fully to

patients. Patients who are enrolled in the program and who are hospitalized

will be able to receive the drugs in the hospital, but hospitals will not

have to enroll in the program. The new rules take effect Nov. 18. *

*

LINK<http://www.diabetesincontrol.com/index.php?option=com_content & view=article & \

id=10950 & catid=1 & Itemid=17>

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