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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.
Published on Apr-26-12
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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