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Actos Heart Failure Incidence not Reported to FDA

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Washington, DC: Documents recently unsealed by US Judge F. Dennis Saylor in a whistleblower Actos lawsuit filed by Helen Ge in U.S. District Court, District of Massachusetts, reveals that Takeda Pharmaceutical appeared to know of bladder cancer and congestive heart failure - or CHF - adverse events for Actos, but failed to report them to the FDA.

Dr. Ge, a former Takeda Pharmaceutical medical reviewer, claims Takeda failed to report all cases of Actos heart failure to the FDA. "Takeda instructed its medical reviewers not to report hundreds of non-hospitalized or non-fatal congestive heart failure cases as 'serious adverse events and thus avoided its responsibility of accurately analyzing and reporting these hundreds of serious adverse events to the FDA," Ge says in her lawsuit, which was recently summarized in Lawyers Weekly USA (3/19/12).

When Ge approached Takeda with the accusation that the pharmaceutical company was underreporting cases of Actos heart failure and congestive heart failure events to the FDA, her contract with the firm was abruptly terminated.

A 24-week post-marketing safety study performed to compare Actos to glyburide (a drug that is also used to treat type 2 diabetes and is in a class called sulfonylureas) in uncontrolled diabetic patients. Over the course of the study, overnight hospitalization for congestive heart failure was reported in 9.9% of patients on Actos compared to 4.7% of patients on glyburide.

Actos is a popular diabetes drug used to control Type 2 diabetes. It was introduced in 1999 and is manufactured by Takeda Pharmaceutical.

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Last updated on Apr-26-12


READER COMMENTS

Posted by
Anonymous
on
I was a victim for over 15 years unfoundedly and given statins as called today which took my life plus more drugs to treat the results of all that was done to me under prescription drugs . In that duration of time I not only was under the control of all but also in time all took its affect on my body causing me diabetes, parkinsons, degenerative osteo arthiritis and spinal stenosis having been so over medicated that I did not do one thing for over 3 years under all.but sit and look out the window and sleep, heart attack . and more I was given in that span of time over 28 different drugs and never ever told any serious consequences or as the drug mfg state, side effects till all too late . I dam all and like to inform any and all prescribed any drug to take serious steps and attain info on all before ever digesting only with the word of a doctor , I mean that 100 %.. To be a victim and still able to be here to tell what I am saying is a blessing but also a shame that drug MFG's seize on all they do to make us think all will help but truly know in advance the adversary effects to damage good lives and to the extreme of taking them lives forever all for the sake of $$ money .& profit in the Billions yearly for the power they have on lifes populations The drugs that took my life I share with all who have taken even one of them that caused there change in life forever . I do not state here at all that they are not beneficial but do state that knowingly the drug mfg's, pharmacies and prescribing doctors are aware of the harm to a % of the population but do not state it and cover up.. Would you sell a product and tell the consumer it was bad ? Of course not and has been going on for years but needs to be told and halted . Here are a few of the drugs that can have serous and diverse effects to those in harms way,, ,, paxil, Prozac, crestor, Ritalin, Zoloft, buspar, Lipitor, Celebrex, vioxx, Risperdal, Seroquel, Avandia , actos , junavia, clonazepam, acetomophin, atorvastatin, and so so many more , I say this for I was the victim of what is written here .. My story is not good ,, Do not let it be yours ,,Investigate before consuming is all I want to say > I was Naïve and believed all without question. . So did my family.. My life was never the same then and never will be ,,, Hope knowledge here is accepted and known of the truth ,,, Bob ,,,

Posted by
Illinois
on
My father had frequent heart palpitations while on Actos. He went to the emergency room for sever heart palpitation and was told that he had atrial fibrillation. He had to be kept in the hospital overnight. He is now regularly taking heart medications. I heard about the side effects of Actos and had asked my dad to have his doctor switch his Actos medication.

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