Actos Heart Problems Not Reported to FDA: Whistleblower Lawsuit

While concerns grew among consumers and the medical community over the risk of heart problems from Avandia, Takeda Pharmaceuticals was allegedly hiding evidence that their competing diabetes drug, Actos, was causing congestive heart failure.

From late 2007 through early 2010, hundreds of cases involving congestive heart failure from Actos went unreported to the FDA, according to a whistleblower lawsuit filed by Helen Ge, a former Takeda medical reviewer.

Ge’s allegations were raised in a complaint filed in 2010, which was just recently unsealed.

Failure to report adverse events associated with prescription medications is a violation of federal laws, and suggests that Takeda may have been attempting to conceal the risk of Actos heart problems to gain a competitive advantage over GlaxoSmithKline’s Avandia, which saw a substantial drop in sales during the same time period.

In May 2007, the first of several studies were released that suggested that the diabetes drug Avandia increased the risk of heart attacks. As evidence mounted, prescriptions for Avandia dropped and sales for Actos increased. The FDA ultimately placed severe restrictions on the use of Avandia in 2010, and several countries banned the drug.

During that time, Avandia was repeatedly compared to Actos, which appeared to be safer for the heart by comparison. However, Ge alleges that the company simply hid data it was receiving on hundreds of cases involving non-hospitalized and non-fatal congestive heart failure among Actos users.

Actos (pioglitazone) was approved by FDA to treat Type 2 Diabetes in July, 1999. It is a once-a-day pill that increases the body’s sensitivity to insulin. Following the fall of Avandia, Takeda saw the popularity of Actos rise, ultimately generating an average of over $4 billion a year in sales.

Federal law requires that pharmaceutical companies forward complaints and concerns regarding their drugs to the FDA’s Adverse Event Reporting System, MedWatch. Ge says that Takeda officials instructed its medical reviewers on several occasions to change their professional opinions on adverse event classifications. She protested and was fired, her complaint states.

Ge’s case was unsealed after the federal government and 24 other states declined to join her lawsuit. Ge is also suing Takeda for allegedly hiding the side effects of Uloric, a gout medication. That lawsuit was unsealed in late January.

Under the qui tam provision of the False Claims Act, whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim.

The allegations come as Takeda Pharmaceuticals faces a growing number of Actos bladder cancer lawsuits filed by consumers who allege that the drug maker failed to adequately disclose that long-term use of the medication may increase the risk of tumors. Hundreds of complaints have been filed by individuals throughout the United States who developed bladder cancer after using the type 2 diabetes drug, alleging that Takeda turned a blind eye to the potential side effects of Actos.