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cardiovascular 27 articles

Canadian regulators warn consumers about cardiovascular risks of testosterone drugs

Canada’s national health regulators have issued a warning to consumers and health care providers about the serious risks associated with the use of testosterone-replacement drugs, which are being prescribed to increasing numbers of men as a treatment for low natural testosterone levels. Health Canada said its safety review of testosterone drugs involved evaluating the currently available studies and reports on the cardiovascular risks the drugs presented. In the course of its safety review, the agency found “a growing body of evidence suggesting a possible association between the use of testosterone replacement products and cardiovascular risk.” As in the U.S., men ... Read More

Stress test drugs linked to heart attack, death risk

Cardiac nuclear stress test agents Lexiscan (regadenoson) and Adenoscan (adenosine) have been linked to a rare but serious risk of heart attack and death, the Food and Drug Administration (FDA) warned. The drugs are used to identify coronary artery disease in patients who cannot exercise adequately and are unable to undergo traditional exercise stress tests. The Warnings & Precautions section of Lexiscan and Adenoscan labels previously contained information about the possible risk of heart attack and death with use of these drugs. However, recent reports of serious adverse events reported to the FDA and in medical literature have prompted the FDA ... 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

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

Injection used during diagnostic imaging recalled due to particle contamination

Nine lots of the injectable solution Isovue (iopamidol) used during diagnostic imaging are being recalled because of the presence of visible particles in the syringes. The recall, initiated by Bracco Diagnostics Inc., is categorized as a Class 1, which is the most serious type of recall reserved for products that predictably could cause serious health problems or death. The recall involves Isovue Pre-Filled Power Injector Syringes (PFS), which are used in combination with Stellant CT Injection Systems. Isovue PFS is a single use item, administered for agiography throughout the cardiovascular system, and arterial injection for cerebral angiography. If used, the ... Read More

‘Lifestyle intervention’ for weight loss does not improve heart attack risk in diabetics

Longtime type 2 diabetics who undergo “lifestyle intervention” and lose weight do not reduce their heart attack and stroke risk, suggests a new study supported by the National Institutes of Health. The study focused on whether an intensive diet and exercise program resulting in weight loss would reduce the rates of heart disease, stroke, and cardiovascular-related deaths in overweight and obese people with type 2 diabetes. This demographic is already at greater risk for these conditions. For the study, researchers worked with more than 5,000 people. Half of the participants engaged in an intensive diet and exercise program while the ... 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

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