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Pradaxa-maker Kept FDA in Dark about Bleeding Risks

Regulators were kept in the dark about important data Boehringer Ingelheim had about the safety of its oral direct thrombin inhibitor dabigatran (Pradaxa) while the drug was under review for approval in nonvalvular atrial fibrillation (AF), according to several documents published Wednesday in the British Medical Journal (BMJ).

The four documents indicate that Boehringer Ingelheim didn’t share its own analysis with U.S. or European regulators suggesting a severe reduction in bleeding risk when Pradaxa was dosed with guidance from anticoagulation monitoring. It is likely this information was withheld because if it made its way to the regulators, it would have undermined the key Pradaxa marketing message that no such monitoring would be required, MedScape.com reported. One of alleged benefits of Pradaxa was that unlike warfarin, routine monitoring was not required. More Pradaxa-maker Kept FDA in Dark about Bleeding Risks

FDA Plans August Meeting to Discuss the Confidentiality of Cardiovascular Outcomes Trials

The U.S. Food and Drug Administration (FDA) announced Monday that it will hold a public meeting in August on ways to keep cardiovascular outcomes trials (CVOTs) confidential until they are completed.

Drug manufacturers have typically been required to conduct extensive clinical trials to assess the cardiovascular risks associated with their products to the tune of upwards of tens of thousands of dollars. Since the mid-2000s, the FDA has approved many drugs on the condition that drug companies complete mandatory trials by pre-specified dates, according to RAPS.org. More FDA Plans August Meeting to Discuss the Confidentiality of Cardiovascular Outcomes Trials

Tylenol no Better than Placebo for Back Pain

A large extensive trial has found that when it comes to treating back pain, acetaminophen works no better than a placebo.

The findings go against what consumers have been told for years. Advertisement after advertisement has included claims that acetaminophen, sold under brand names like Tylenol and Panadol, is the best option to treat back pain. Even medical guidelines around the world recommend acetaminophen as a go-to treatment. More Tylenol no Better than Placebo for Back Pain

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