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Avandia Case Similar to Accutane IBD Circumstances

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Washington, DCIn a situation similar to the circumstances surrounding Accutane inflammatory bowel disease, the US Food and Drug Administration recently announced that the diabetes drug Avandia will no longer be sold in pharmacies.

Beginning in November, the medication will only continue to be made available to those safely using it, patients who have not been able to control their blood pressure using other medications, and those who are aware of the risks and still desire to take it, according to HealthDay.

Such risks reportedly include cardiovascular problems including a higher likelihood of suffering a heart attack, according to a number of recently published studies.

Bloomberg reports that the manufacturer of the drug, GlaxoSmithKline, plans to discuss the new limited accessibility plan with physicians and patients over the next few months. The FDA's decision to remove the medication from pharmacy shelves is the latest action taken against Avandia, which was restricted to those with Type 2 diabetes who had not found another successful drug to treat their condition, the news source said.

"It's like a decade-long nightmare coming to an end," chief of cardiovascular medicine at the Cleveland Clinic Dr. Steven Nissen told USA Today. "Eleven years after this drug was introduced, it will be so restricted in access that virtually no one will be able to get it."

Risks of Avandia can be traced all the way back to 2007, when FDA safety expert David Graham reported that the medication had led to heart problems in between 66,000 and 200,000 patients, according to the news source.

The latest action taken against Avandia is reminiscent of the situation with Accutane, which is used in the treatment of acne. Since 2006, isotretinoin has only been given out via an FDA Web site with dermatologists needing to register patients prior to this.

The drug has also reportedly been restricted in the UK, Colombia, Mexico and Brazil, due to the potential for serious side effects such as the development of ulcerative colitis, a form of inflammatory bowel disease (IBD), which has led to a number of lawsuits across the US.

One patient, who claimed the medication was a major factor in her development of the condition, was awarded $2 million in damages after a New Jersey jury found that her decision to take the medication largely centered around the fact that drugmaker Roche had not sufficiently warned about its side effects, according to the Courtroom View Network.


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