Re: FDA internal memo: Both Actos and Avandia caused heart failure deaths


"Susan" <nevermind@xxxxxxxxxx> wrote in message
news:5c8a91F302ll3U1@xxxxxxxxxxxxxxxxxxxxx
x-no-archive: yes

http://www.sciencedaily.com/upi/index.php?feed=Science&article=UPI-1-20070523-22152900-bc-us-avandia-analysis.xml


"In the memo, FDA reviewers analyzed 47 cases of heart failure requiring
hospitalization -- 22 occurred in patients taking Actos and 25 in those
taking Avandia.

"Data from this case series provides evidence that (thiazolidinediones,
the class of drugs that includes Actos and Avandia) may be associated with
(congestive heart failure) to an extent not clearly defined in the product
labels," the reviewers concluded.

They go on to note that the cases do not show conclusively the drugs
caused the heart failure, but they say labeling should mention the
condition has occurred in diabetic patients taking the medications.

Although Avandia's labeling mentions the risk of heart failure has been
detected in clinical studies, Wolfe said the FDA failed to heed the advice
of its reviewers and require the listing of the postmarketing reports --
which now number 415."

Lovely. My old Endo. tried hard to put me on Actos. I refused to take it.
Good thing I did!


.

Relevant Pages