Actos linked to serious psychiatric impairments, medical reviewer alleges
The diabetes drug Actos is linked to higher rates of suicide, schizophrenia, epilepsy, and grand mal seizures compared to other drugs in the same class, such as Avandia, says Dr. Helen Ge, a former medical reviewer in Takeda Pharmaceuticals’ pharmacovigilance department.
Dr. Ge has filed a whistleblower lawsuit against Takeda under the False Claims Act, alleging the company fired her for objecting to its practices of concealing, downplaying, and whitewashing data that linked Actos to serious adverse side effects. She alleges Takeda required her and other medical reviewers to “change their professional opinion regarding adverse event classifications and assessments.”
Her lawsuit against Takeda contends that the company systematically manipulated data to make the blockbuster diabetes drug appear safer than it actually was.
As a Takeda medical reviewer, Dr. Ge evaluated Actos side effects reported by patients taking the drug and their doctors. She also prepared safety reports about the drug based on her findings as mandated by the U.S. Food and Drug Administration (FDA). She alleges Takeda executives repeatedly told her to ignore the adverse side effects and modify her reports accordingly.
According to DrugWatch, “Ge said Actos is in many ways more dangerous than its cousin drug Avandia, which was removed from the shelves several years ago because of heart attack risks.” Both Actos and Avandia are in the thiazolidinedione drug class.
In reviewing Actos data, Dr. Ge found Actos was associated with three to four times more reports of serious psychiatric disorders, including delirium and both suicidal and homicidal thoughts and behavior, than in patients taking Avandia.
Sge also discovered that tucked away in Actos complaints were 11 reports of Neuroleptic Malignant Syndrome (NMS),a potentially fatal neurological disorder usually brought about by a reaction to antipsychotic drugs.
“Ge also said that data collected by Takeda during clinical trials showed that psychiatric disorders occurred in 10 percent of the Actos patients, compared to 5 percent of those on a placebo,” DrugWatch reported. According to Dr. Ge, this information was never recorded in the information packaged with the drug.
She said that reports of serious psychiatric events, including suicide, delirium and homicidal ideals, were three to four times higher in Actos patients than reports regarding Avandia patients. She also said that Actos patients had reported having Neuroleptic Malignant Syndrome (NMS), a rare, life threatening neurological disorder that is most often causes by a reaction to antipsychotic drugs.
“Actos patients have been reported to have NMS 11 times already, suggesting it is a serious side effect linked to Actos use,” she said in the lawsuit.
Ge also said that data collected by Takeda during clinical trials showed that psychiatric disorders occurred in 10 percent of the Actos patients, compared to 5 percent of those on a placebo. This information was never recorded in the drug package insert, Ge said.
“Takeda did not include this group of highly frequent serious psychiatric events in the label, and has been concealing this important safety information from the public for many years,” she said. In fact, several reports blaming Actos for several seizure-related emergencies including epilepsy and grand mal convulsions never became part of the Actos packaging, meaning patients and doctors were likely unaware these risks existed.
“Takeda did not include this group of highly frequent serious psychiatric events in the label, and has been concealing this important safety information from the public for many years,” she said.
“Takeda’s motivation to fraudulently report and under report the serious adverse events were driven by an economic desire to falsely enhance Actos’ safety profile and to increase sales,” Dr. Ge’s lawsuit asserts.
For more information about whistleblower laws, visit www.beasleyallen.com.