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Takeda Pharmaceuticals 54 articles

Increased risk of death with gout drug Uloric

People treated with the gout drug febuxostat, known by the brand name Uloric, are at an increased risk of death compared to those taking the gout medicine allopurinol, the Food and Drug Administration (FDA) cautioned in a safety communication. The agency is requiring a boxed warning – its most serious warning – be added to the safety label of febuxostat based on a review of a large, post-market safety study. “This conclusion is based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric,” ... Read More

FDA orders name change for Brintellix to reduce prescribing errors

The brand name of the antidepressant Brintellix (vortioxetine) will be changed to Trintellix, in order to decrease the risk of prescribing and dispensing errors with the blood thinning medication Brillinta (ticagrelor), the Food and Drug Administration (FDA) announced. The name change will go into effect June 2016. No other changes will be made to the label or packaging. The medicine Brintellix/Trintellix is exactly the same and the tablets look the same. Because of the time lag with manufacturing bottles with the new brand name, health care professionals and patients may continue to see bottles labeled with the brand name Brintellix ... Read More

Heart safety trial on diet drug Contrave halted prematurely

Takeda Pharmaceuticals Co. is threatening to sever its partnership with Orexigen Therapeutics Inc. after a safety study on the diet drug Contrave was halted because trial data was released prematurely. Orexigen had announced last March – when only about 25 percent of the data was in – that early data from a clinical trial to evaluate cardiovascular outcomes with Contrave showed patients taking the obesity medication had a reduction in heart-related deaths. The information was released as part of a patent application. The Food and Drug Administration (FDA) criticized Orexigen for releasing the information too soon, saying the trial’s integrity had ... Read More

Fifth Circuit Court dismisses Actos bladder cancer appeal

The Fifth Circuit Court dismissed an appeal by Takeda Pharmaceuticals Co. and Eli Lilly & Co.’s involving a $36.8 million award to a plaintiff who claimed the companies’ type 2 diabetes drug Actos caused bladder cancer. The action comes just weeks after Takeda announced it would pay $2.4 billion to settle about 97 percent of Actos bladder cancer lawsuits. In 2011, Susan and Terrence Allen filed a lawsuit against the companies claiming that Terrence’s seven-year use of Actos to treat type 2 diabetes caused him to develop bladder cancer. They also claimed that the drug companies covered up cancer risks with ... Read More

Diabetes drug Actos linked to weight gain

Obesity is a risk factor for type 2 diabetes and most patients who suffer from the condition are encouraged to lose weight. However, a type of commonly used diabetes drugs can actually increase body fat in people, according to new research published in The Journal of Neuroscience. The body fat increase was associated with a class of type 2 diabetes drugs known as thiazolidinediones, or TZDs. Drugs in this class include Actos (pioglitazone), Actoplus Met (pioglitazone and metformin), Duetact (pioglitazone and glimepride), Avandia (rosiglitazone), Avandamet (rosiglitazone and metformin), and Avandaryl (rosiglitazone and glimepride). The medical community has known for a ... Read More

Study clears Nesina of heart risk; cancer risk still questionable

The type 2 diabetes drug Nesina (alogliptin) does not increase the risk of heart failure or cardiovascular risk, according to a new study published in the journal The Lancet. Death and disability from heart disease is rampant among individuals with type 2 diabetes. Concerns have been raised over the years about how some diabetes medications affect cardiovascular health after the drug Avandia was severely restricted when studies linked the medication to fatal heart attacks. As a result, Food and Drug Administration (FDA) now requires that a comprehensive evaluation of the cardiovascular safety profile be conducted on all new diabetic therapies. ... Read More

Takeda ordered to pay $2.3 million in latest Actos bladder cancer lawsuit

Takeda Pharmaceuticals was ordered to pay $2.3 million by a Philadelphia jury that found the company’s type 2 diabetes drug Actos caused a man to develop bladder cancer, and that his doctor was not adequately warned of the risks. John Kristufek was awarded $318,000 in past medical expenses plus $2 million in noneconomic damages after nearly a month of testimony. Kristufek claimed he took Actos for about three years before being diagnosed with bladder cancer in 2008. His lawsuit claims that the drug company tried to cover up bladder cancer risks with Actos use. It wasn’t until July 2011, a few weeks ... Read More

Judge slaps Takeda with additional damages in Actos bladder cancer lawsuit

A Pennsylvania judge refused to overturn a $2 million verdict against Takeda Pharmaceuticals Inc. involving claims that its type 2 diabetes drug Actos caused bladder cancer, and slapped the drug company with nearly $100,000 in additional damages for the delay. Plaintiff Frances Wisniewski filed the lawsuit in Philadelphia Court of Common Pleas in July 2012 claiming she developed bladder cancer after taking Actos for seven years. In August 2011, the Food and Drug Administration (FDA) ordered Takeda to update the safety label of Actos to include warnings for bladder cancer risk in patients who used the drug for more than a ... Read More

Another Actos bladder cancer case goes to trial

In 2011, three years after John Kristufek began taking the type 2 diabetes drug Actos,, he developed bladder cancer. Coincidentally that same year, studies linked Actos to an increased risk of type 2 diabetes. Since then, evidence began to surface that Actos maker Takeda Pharmaceuticals knew its blockbuster diabetes drug could cause bladder cancer but failed to warn doctors or patients. Now, after several procedures to have recurring tumors removed and, subsequently his entire bladder removed, Kristufek is getting his day in court. Kristufek’s filed his lawsuit alleging the Actos bladder cancer link in July 2012 in the Philadelphia Court ... Read More

Many newer diabetes drugs carry cancer risks

Within the past two decades, thanks in large part to diabetes experts lowering the blood sugar threshold, millions more Americans were labeled as diabetic and became eligible for medication to help regulate blood sugar levels. As a result, the diabetes drug industry boomed. Sales of diabetes drugs topped $23 billion, more than the revenues generated from the National Football League, Major League Baseball, and the National Basketball Association combined. But in the past decade, a Milwaukee Journal Sentinel and MedPage Today investigation discovered that none of the 30 new diabetes drugs were proven to improve diabetics’ risk for associated health ... Read More