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Takeda 43 articles

New warnings added to IBS treatment Amitiza

An updated safety label for the constipation and irritable bowel syndrome (IBS) medication Amitiza with the addition of two new adverse reactions has been approved by the Food and Drug Administration (FDA). The new labeling will include that cases of syncope (temporary loss of consciousness due to a drop in blood pressure) and hypotension (abnormally low blood pressure) have been reported in patients treated with the drug. In most cases, syncope or hypotension have occurred in patients taking 24 mcg twice daily and some occurred within an hour after taking the first dose or subsequent doses. The new label states that ... Read More

Jury increases award in Actos bladder cancer lawsuit to $3.6 million with punitive damages

One day after a Philadelphia jury slapped Takeda Pharmaceuticals company with a $2.3 million award for failing to warn about bladder cancer risks with its blockbuster type 2 diabetes medication Actos, the jury handed down an additional $1.3 million in punitive damages against the drug company for its reckless indifference in the health of the plaintiff, a retired school teacher who claimed Actos caused him to develop bladder cancer. John Kristufek claimed he took Actos for three years before being diagnosed with bladder cancer in 2008. His doctor took him off the drug after he learned that Actos had been ... Read More

Takeda to pay $2 million in latest Actos bladder cancer trial

A Philadelphia jury deliberated more than five hours before ordering Takeda Pharmaceutical Co., was ordered to pay more than $2 million to a woman who claimed the company’s type 2 diabetes drug Actos caused her to develop bladder cancer. The verdict is the latest of thousands involving Actos bladder cancer claims to go to trial. Plaintiff Frances Wisniewski argued that Japan-based Takeda knew of the bladder cancer risks associated with Actos but failed to adequately warn doctors or patients of the risk. Wisniewski is the seventh Actos user to go to trial. A previous case resulted in a $9 billion ... Read More

Controversial analysis suggests Actos may help protect users from dementia

The type 2 diabetes drug Actos could help ward off dementia, a new analysis has found. However, researcher say more analysis is needed as well as adverse side effects addressed before the medication can be recommended as a preventative measure. The analysis involved data from Germany’s biggest public health insurer, which included about 146,000 patients aged 60 or older. The patients were tracked from 2004 to 2010, during which time about 14,000 of them developed dementia. When prescriptions for Actos were factored into the analysis, researchers found that patients taking Actos had about a 6 percent decline in the likelihood ... Read More

Five years of Actos likely caused plaintiff’s terminal bladder cancer, doctor testifies

A University of Chicago Medical Center urologist told a Los Angeles jury last week that Takeda Pharmaceuticals’ type-2 diabetes drug Actos was “the most substantial causative factor” in a California man’s development of terminal bladder cancer. The doctor’s testimony was part of the first product liability case against Takeda to go to trial over injuries allegedly caused by the blockbuster drug. Plaintiff Jack Cooper, a 79-year-old San Diego area resident, sued Japan-based Takeda after taking Actos for a five-year period from 2006 to 2011. His lawsuit against Takeda was selected as the first of more than 3,000 similar cases to ... Read More

Kentucky files Avandia lawsuit against GlaxoSmithKline

Drug maker GlaxoSmithKline (GSK) was slapped with a lawsuit by Kentucky’s attorney general, alleging that the company’s type 2 diabetes drug Avandia violated the state’s Consumer Protection Act by overstating the effectiveness of the drug and hiding information that showed the drug could cause serious and often fatal heart attacks. “We will not stand idly by as drug companies operate outside the law and put Kentuckians’ health at risk,” Attorney General Jack Conway told the Associated Press. The lawsuit was filed in Franklin County Circuit Court in Frankfort, Ken., and seeks civil penalties of up to $10,000 per violation. Kentucky’s ... Read More

Newly approved type 2 diabetes drugs come with warnings, requirements

After more than five years of reviews and rejections, the dipeptidyl peptidase IV (DDP-4) inhibitor alogliptin has finally been approved by the Food and Drug Administration (FDA). The new drug was approved in three versions to improve blood sugar control in adults with type 2 diabetes. Nesina contains alogliptin as a single-agent drug; Kazano contains alogliptin with metformin; and Oseni contains alogliptin with pioglitazone. The drugs are to be prescribed in combination with diet and exercise. Alogliptin is the fourth DDP-4 inhibitor to gain FDA clearance. Others include sitagliptin, sold under the brand name Januvia; saxagliptin, sold as Onglyza; and ... Read More

New Actos lawsuit accuses Takeda of inadequately stating, concealing drug’s risks

A Minnesota man has filed a lawsuit against Takeda Pharmaceuticals and Eli Lilly and Company for injuries he allegedly received as a result of taking the diabetes drug Actos (pioglitazone). The plaintiff, one of the latest to join the Actos litigation consolidated in federal court in Lafayette, Louisiana, claims the type 2 diabetes drug caused him to develop bladder cancer. He seeks damages for permanent injuries, severe mental and physical pain and suffering, and economic losses related to his medical expenses and the costs of maintaining a change in lifestyle brought about by his injuries. Like many plaintiffs who allege ... Read More

First Actos bladder-cancer claim against Takeda headed to trial in February

The first lawsuit against Takeda Pharmaceuticals and related companies over Actos injuries will be heard February 19 in Los Angeles Superior Court. In that case, Mississippi resident Jack Cooper alleges that he developed bladder cancer as a result of taking Actos to treat his type 2 diabetes. Mr. Cooper filed his lawsuit in California, where Japan-based Takeda keeps its North American headquarters. Because it will be the first Actos case to go to trial, Mr. Cooper’s lawsuit will serve as a bellwether for potentially thousands of other such cases filed throughout the country. A recent Business Week report estimates the number of ... Read More

GSK to pay an additional $90 million in Avandia heart attack claims

GlaxoSmithKline (GSK), makers of the type 2 diabetes drug Avandia, agreed to pay $90 million to settle claims by 37 states and the District of Columbia that the drug company illegally promoted the medication and misled consumers about whether the blockbuster prescription medication caused deadly heart attacks and strokes in order to boost sales. The settlement is yet another financial blow to GSK, which has already paid more than $3 billion to resolve government investigations into questionable marketing of Avandia and other drugs. One of the charges involved the company’s failure to report safety data about Avandia. Avandia is in ... Read More