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Health Canada Warns of Dangers of Testosterone Products

Testosterone hormone replacement products carry a risk of serious and possibly life-threatening cardiovascular (heart and blood vessel) problems, according to a new health advisory released by Health Canada.

Testosterone hormone replacement products are intended to be taken by men who are experiencing medical conditions because their body cannot make enough testosterone. However, many of the products are also marketed to improve sex drive and end up being taken by men who do not have a medical condition. More Health Canada Warns of Dangers of Testosterone Products

Human Sues Medtronic, Accuses the Company of Falsely Representing its Infuse Bone Growth Product

Managed care company Humana has sued Medtronic Inc., accusing the company of falsely representing its Infuse bone growth device as safe and effective in spinal fusion surgeries.

Humana filed the lawsuit in federal court in Tennessee on Friday. The complaint alleges that Medtronic paid for academic literature that fraudulently portrayed Infuse as safe and effective for off-label uses. According to court documents, Humana said that Medtronic engaged in a “sophisticated and deeply deceptive marketing strategy” designed to expand the market for Infuse, by urging and compensating spine surgeons to use the device by over-emphasizing its benefits and downplaying its serious risks, Reuters reported. More Human Sues Medtronic, Accuses the Company of Falsely Representing its Infuse Bone Growth Product

Boehringer Ingelheim Settles Pradaxa Bleeding Cases

Boehringer Ingelheim announced Wednesday that it has reached a settlement of state and federal cases involving litigation regarding its blood clot medication Pradaxa. The settlement is reported to be in the amount of $650 million.

Boehringer is hoping to resolve approximately 4,000 claims with this settlement. The company said it expects the vast majority, if not all, of the plaintiffs to accept the terms of the settlement, InsuranceNewsNet.com. More Boehringer Ingelheim Settles Pradaxa Bleeding Cases

NaturaLyte Liquid Bicarbonate Concentrate Recalled Nationwide and in Canada

The U.S. Food and Drug Administration (FDA) recently announced a recall that involves the entire United States and Canada of NaturaLyte® Liquid Bicarbonate Concentrate over its potential health risk. The product is manufactured by Fresenius Medical Care North America.

Fresenius announced that 56 lots of its NaturaLyte® Liquid Bicarbonate Concentrate, in the 6.4 liter size, are being removed from distribution. The NaturaLyte® Liquid Bicarbonate Concentrate is meant to be used in hemodialysis machines. More NaturaLyte Liquid Bicarbonate Concentrate Recalled Nationwide and in Canada

Medtronic Tries to Settle Infuse Cases but Many Patients May Still See Their Day in Court

More than 6,500 reports of injuries related to Medtronic’s Infuse bone growth product have flooded into the U.S. Food and Drug Administration (FDA) since 2002. About 3,300 were registered with the agency’s medical device reporting system last year alone. Now, the company is settling as many cases as possible while patients await their day in court.

Medtronic told investors last week that it will pay $22 million to settle about 950 claims and is setting aside $140 million to settle future claims, according to MedPageToday.com. More Medtronic Tries to Settle Infuse Cases but Many Patients May Still See Their Day in Court

Researchers Want Females Represented in Animal Studies

Two leaders from the National Institutes of Health are calling on drug researchers to start including female rats as test subjects in drug research.

As it currently stands, many animal trials involving various drugs only include male rats, pigs, or dogs, Slate.com reported. Dr. Frances Collins and Dr. Janine Clayton believe the over-reliance on male animals and cells in preclinical research obscures key sex differences that could guide clinical studies. They said this could potentially be harmful because women experience higher rates of adverse drug reactions than men do. More Researchers Want Females Represented in Animal Studies

Chicago Jury Decides Takeda Pharmaceutical Co. is not Responsible for Man’s Bladder Cancer Death

Takeda Pharmaceutical Co. is not responsible for the death of a man who died in 2006 after taking the Type 2 diabetes drug Actos, a jury decided yesterday.

A lawyer for the family of William Whitlach, 57, urged the jury to award at least $10 million to his wife and children for pain, suffering, and financial losses caused by his death. During the closing arguments of the four-week trial, the attorney said Takeda continued to sell its Actos even though it knew caused bladder cancer in order to maximize returns before competing generic versions reached the market, BusinessWeek.com reported. More Chicago Jury Decides Takeda Pharmaceutical Co. is not Responsible for Man’s Bladder Cancer Death

Corticosteroid Injections Linked to Injuries and Death

Injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death, the U.S. Food and Drug Administration (FDA) said in a warning.

The injections are given to treat neck and back pain, and radiating pain in the arms and legs. The FDA is requiring the addition of a warning to the drug labels of injectable corticosteroids to describe these risks. The agency is recommending that patients discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. More Corticosteroid Injections Linked to Injuries and Death

Woman who Suffered Injuries from use of Yasmin Awarded $14 Million

A suburban Chicago woman who alleged in a lawsuit that she suffered a serious stroke after taking the Bayer’s birth control drug Yasmin was awarded $14 million by a jury on Friday.

Mariola Zapalski said her stroke occurred just 13 days after she began taking Yasmin. The stroke paralyzed her left side and caused permanent brain injury, the Associated Press reported. More Woman who Suffered Injuries from use of Yasmin Awarded $14 Million

European Agency Investigating Testosterone Therapy Link to Cardiovascular Risk

The European Medicines Agency (EMA) is following the footsteps us the U.S. Food and Drug Administration (FDA) and launching an investigation into testosterone therapies to find out what potential cardiovascular side effects they may cause.

The EMA’s decision to act is based on the same pair of studies the FDA cited when it opened an investigation in February. A November study that appeared in the Journal of American Medical Association found a greater risk of cardiovascular injury and death in Veterans Affairs population, according to MedPageToday. A January study in Plus One also found that men 65-years and older were at an increased risk of cardiovascular issues when on the testosterone drugs.

More European Agency Investigating Testosterone Therapy Link to Cardiovascular Risk