Canadian Drug Regulator Issues Warning About the Diabetic Drug ACTOS

Health Canada in conjunction with Takeda Canada Inc., manufacturer of the drug actos, issued a safety advisory yesterday in Toronto, stating that taking the anti-diabetic medication may increase a patient’s  risk of developing bladder cancer. The warning is a result of a safety assessment review started by Takeda and Health Canada last year.

ACTOS is a brand name for the drug pioglitazone. It is prescribed to help regulate blood sugar in adult patients who suffer from Type 2 diabetes.

Health Canada reports in its advisory that Takeda is at the midway point of a ten year study which shows an increased rate of bladder cancer in people who use pioglitazone to control their type 2 diabetes. The risk appears to be highest in people who have taken the drug for the longest duration or at the highest dosages, but short term use has not been ruled out as a risk factor.

The safety assessment recommends that actos should not be used in patients who have or have had bladder cancer. Any blood or red color in urine should be investigated before starting pioglitazone therapy. The patient should be assessed for risk factors related to bladder cancer, (these risks include age, smoking, family history of bladder cancer workplace exposure to chemicals and certain types of cancer treatments/radiation therapy).

In the United States, the actos bladder cancer lawyers, Baum, Hedlund, Aristel & Goldman are representing a former employee of Takeda Pharmaceuticals, in a whistleblower lawsuit.  Dr. Helen Ge a medical doctor, who was employed in the company’s pharmaco vigilance division to review adverse events and identify and evaluate potential safety signals for actos,  asserts she had direct knowledge of the actos bladder cancer risk  and according to the complaint she encountered resistance from her superiors when she tried to report bladder cancer as related to actos.

Dr. Ge claims the she was directed by her supervisors to change her “related” assessment to unrelated. She also recollects reviewing Takeda’s adverse event data base for actos, where there were more than 100 bladder cancers reported to the company, but only 72 were reported to the Federal Drug Administration, which she states is “a serious discrepancy.” Dr. Ge also states in her complaint that carcinogenesis (the process of initiating and promoting cancer), from actos was discovered during the initial actos animal studies.

In addition she alleges that Takeda failed to report all of the actos related Congestive Heart Failure adverse events to the FDA. According to the complaint the company instructed its medical reviewers not to report hundreds of non-hospitalized or non-fatal Congestive Heart Failure cases as “serious” adverse events to the FDA. Dr. Ge estimates that Takeda failed to report several hundred Congestive Heart Failure events as serious between late 2007 and 2010.

Senior Partner at Baum Hedlund; Michael Baum outlined the case “We believe that the documents we obtain in discovery will show that the fraud Takeda committed, violated the False Claims Act and has caused tens of thousands of false claims to be made on federal and state health care programs, causing hundreds of millions of dollars in damages.”

Dr. Ge complained to her superiors that her medical assessments were being downgraded from “serious” to “non-serious” and as a result of this; the Congestive Heart Failure events were being under-reported to the FDA. Dr. Ge’s contract was terminated.

Baum, Hedlund, Aristel & Goldman have filed actos bladder cancer lawsuits in state and federal courts against Takeda Pharmaceuticals accusing the drug company of illegally marketing the diabetes drug actos when it knew or should have known that it was linked to an elevated risk of bladder cancer.

Baum Hedlund attorney Cynthia Garber stated “Takeda had a responsibility to warn healthcare workers and patients of the risks of bladder cancer associated with actos. Instead, they watched profits soar with tight lips.”

The lawsuit asserts that Takeda was negligent in its failure to inform prescribing Doctors, and the Public of the deadly risk in order to continue realizing huge profits from the sale of its diabetes drug. Some estimates say in 2008 the company netted profits from the sale of actos amounting to $2.4 billion US.



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