The controversial type 2 diabetes drug Actos has a strong link to suicide, schizophrenia, epilepsy and grand mal seizures when compared to its dangerous predecessor, additional claims in a federal whistleblower lawsuit said.
Dr. Helen Ge, who once worked for the drug’s manufacturer Takeda Pharmaceuticals, said the rate of such occurrences in Actos patients is higher than that seen in patients who took drugs in the same class, such as Avandia. In March, Ge filed a federal whistleblower lawsuit, also claiming that Takeda repeatedly hid the drug’s ties to heart conditions and various types of cancer.
Lawsuit: Takeda Ignores Dangerous Side Effects
From 2008 to 2010, Ge worked as a safety consultant for Takeda’s pharmacovigilance division, reviewing the side effects reported by Actos patients and their physicians. As part of her job, she prepared Food and Drug Administration (FDA)-mandated safety reports about Actos. She said Takeda executives continually encouraged her to disregard the reported side effects and change documents to make the drug look better.
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 drugs are come from the same drug class, thiazolidinediones.
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.
Concealing Health Risks for Profit
In the lawsuit, Ge went on to say that Takeda received clusters of reports regarding seizure-related medical emergencies from Actos users, including epilepsy and grand mal convulsions, but “never included them in the Actos label.”
“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,” she said.
Today, Ge’s lawsuit is inching its way through the U.S. District Court in Massachusetts, but it has plenty of legal experts taking notice. Already hundreds of people have filed lawsuits against the drug maker in federal and local courts nationwide for the drug’s tie to bladder cancer and heart failure, saying the company concealed the drug’s risks to make a profit. With that, the tie to psychiatric problems many not come as a surprise to some.
If you or a family member took Actos and developed bladder cancer or congestive heart failure, call (800) 452-0949 to speak with a Patient Advocate. You may be eligible to receive compensation for medical expenses related to Actos injuries.