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U.S. food and drug administration 60 articles

Fraudulent mislabeling of seafood products rampant, DNA testing finds

Genetic testing of hundreds of seafood samples found that one-third of the products were mislabeled as being something other than what the packaging said, according to the ocean conservation group Oceana. The group’s study, conducted to determine whether seafood packaging is “honestly labeled,” examined 1,215 seafood samples collected from nearly 674 retail stores in 21 states. DNA testing on the samples found that 33 percent of the products were mislabeled according to U.S. Food and Drug Administration (FDA) guidelines. According to Oceana, “Of the most commonly collected fish types, samples sold as snapper and tuna had the highest mislabeling rates … ... 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

Court overturns FDA’s decision barring Watson from making generic Actos

Prescriptions of Takeda Pharmaceutical’s blockbuster diabetes drug Actos (pioglitazone) have plummeted since a number of clinical studies linked the drug to a significantly higher risk of bladder cancer in patients, but those safety concerns haven’t dissuaded a group of other drug makers from fighting over the rights to make their own generic versions as Takeda’s Actos patent expires. On Monday, U.S. District Judge Amy Berman Jackson in Washington overturned the U.S. Food and Drug Administration’s (FDA) decision to bar Watson Pharmaceuticals from joining a period of shared exclusivity the agency grants to companies that are first to file for the ... Read More

Several patients sue Takeda over Actos injuries, cancer in Los Angeles

Fourteen people have filed a personal injury lawsuit against Takeda Pharmaceuticals alleging the its diabetes drug Actos (pioglitazone) caused them to develop bladder cancer. The lawsuit, filed in Los Angeles Superior Court, also names Takeda’s subsidiaries and Eli Lilly, which helped the Japan-based drugmaker market the blockbuster drug. According to the plaintiffs’ lawyers, the former Actos users claim the drug promoted the growth of bladder cancer and a number of related complications, including “permanent, severe and debilitating injuries, pain and suffering, and emotional distress.” As a result of the injuries allegedly brought about by Takeda’s “negligence, fraud and malice,” the ... Read More

Auburn University now the headquarters for FDA’s food-safety training program

The U.S. Food and Drug Administration (FDA) has chosen Auburn University as headquarters for a national food-safety training program established under the federal Food Safety Modernization Act, which was  signed into law in January 2011. Auburn will receive $6.5 million in federal funds to support the five-year program, which aims to standardize training and establish certifications for food inspectors at all levels. Ultimately, the program aims to reduce the number of food contamination incidents in the U.S., which sicken 76 million people each year and kill an estimated 5,000. About 300,000 people are hospitalized from food-borne illness every year, according ... Read More

Takeda faces Actos class-action in Quebec

MONTREAL, QUEBEC–A group of Actos patients from Quebec, Canada have filed a class action lawsuit against Takeda Pharmaceuticals and its affiliate Eli Lilly in an effort to collect damages for injuries they allege were brought about by the blockbuster diabetes drug. The latest Canadian lawsuit asserts that Japan-based Takeda and Indiana-based Eli Lilly knew about but failed to disclose critical safety information that the popular drug, used to treat patients with type 2 diabetes, promotes the development of bladder cancer. The Quebec patients involved in the new class action developed bladder cancer as a result of taking Actos, the lawsuit ... Read More

Researchers to test Actos as potential Alzheimer’s treatment

Takeda’s controversial diabetes drug Actos could soon be used to treat patients at high risk of developing Alzheimer’s disease, opening the drug to an entirely new customer base beyond diabetic patients. Previous research has established a link between decreased glucose utilization in the brain and Alzheimer’s disease. Actos (pioglitazone) is used to regulate glucose (blood sugar) in the body by making cells more sensitive to insulin – a natural hormone that stabilizes blood sugar levels. Only recently have researchers discovered that Actos taken by diabetic patients reaches the brain. Expanding on that knowledge, researchers with Takeda and Zinfandel Pharmaceuticals used ... Read More

Another new study finds Actos elevates bladder cancer risk

A new Canadian analysis of previously completed Actos studies has linked Takeda’s blockbuster diabetes drug to an increased risk of bladder cancer yet again. Jeffrey A. Johnson, the Canada Research Chair in Diabetes Health Outcomes at the University of Alberta’s School of Public Health and the study’s senior author, told HealthDay News the analysis found Actos (pioglitazone), used to treat type 2 diabetes, is associated with a 22 percent increased risk of developing bladder cancer. According to Dr. Johnson, it’s not known precisely how Actos elevates the bladder cancer risk, but some studies suggest the drug may cause crystals to ... Read More

New study links Actos and Avandia to vision problems

A new study published in The Archives of Internal Medicine has found that patients taking thiazolidinediones, a class of type 2 diabetes drugs that includes Actos and Avandia, may be at a higher risk of developing vision problems. The study monitored more than 103,000 patients with type 2 diabetes over a period of about 10 years. Researchers found that those who took either Actos or Avandia had a risk of developing macular edema two to three times higher than those who didn’t use the popular drugs. The eye disorder occurs when protein deposits collect on or under the central part ... Read More