GAO to Investigate Approval By FDA of 2 Popular Drugs

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GAO to Investigate Approval By FDA of 2 Popular Drugs

The Government Accountability Office will look into whether the Food

and Drug Administration's drug-review process cleared two popular

medications without sufficient proof of their safety or effectiveness,

a senator said yesterday.

Sen. E. Grassley (R-Iowa) requested the GAO investigation

after recent studies suggested that the diabetes pill Avandia and the

cholesterol drug Vytorin may not lower the risk of heart attack and

artery-clogging plaque, as assumed by millions of patients and doctors.

" There's enough of a pattern of problematic drugs to ask for an

independent review of how the FDA follows up on the effects of

medicines that it's approved, " Grassley said in a statement.

At issue is whether the FDA should approve drugs based on biological

measures, such as cholesterol and blood sugar, without evidence that

they improve more meaningful measures such as survival.

Stronger Warnings on Risks Added to 2 Flu Medications

Two pharmaceutical companies said they have added new labels to their

prescription flu medications, citing reports of abnormal psychiatric

behavior in some patients.

A warning about cases of delirium and unusual behavior had been issued

previously on Tamiflu, a product of Roche Group. That language has

been strengthened to say that some of the cases were fatal.

GlaxoKline said it has added a warning about delirium and

abnormal behavior to the label for its flu drug, Relenza. That

language also notes that " the contribution of Relenza to these events

has not been established. " Both drug labels say the cases " appear to

be uncommon. "

http://www.washingtonpost.com/wp-dyn/content/article/2008/03/04/AR2008030402717.\

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