Blood thinner drug manufacturer withheld critical safety data from FDA

Most Viewed Articles
Popular on Facebook
BACK INTO THE CLOSET: Why U.S. reporters are not allowed to write about rainbow events in nations where being gay is still condemned
Depopulation test run? 75% of children who received vaccines in Mexican town now dead or hospitalized
A family destroyed: Six-month-old dies after clinic injects baby with 13 vaccines at once without mother's informed consent
INVESTIGATION: Three days before Dr. Bradstreet was found dead in a river, U.S. govt. agents raided his research facility to seize a breakthrough cancer treatment called GcMAF
BAM! Chipotle goes 100% non-GMO; flatly rejecting the biotech industry and its toxic food ingredients
BOMBSHELL: China and America already at war: Tianjin explosion carried out by Pentagon space weapon in retaliation for Yuan currency devaluation... Military helicopters now patrolling Beijing
ECONOMIC SLAVERY FOR ALL: While we were distracted with the Confederate flag flap, Congress quietly forfeited our entire economic future via fast-track trade authority
March Against Monsanto explodes globally... World citizens stage massive protests across 38 countries, 428 cities... mainstream media pretends it never happened
GMO crops totally banned in Russia... powerful nation blocks Monsanto's agricultural imperialism and mass poisoning of the population
SCOTUS same-sex marriage decision may have just legalized the concealed carry of loaded firearms across all 50 states, nullifying gun laws everywhere
Nearly every mass shooting in the last 20 years shares one surprising thing? and it's not guns
Vicious attack on Dr. Oz actually waged by biotech mafia; plot to destroy Oz launched after episode on glyphosate toxicity went viral
Holistic cancer treatment pioneer Dr. Nicholas Gonzalez dies suddenly; patients mourn the loss of a compassionate, innovative doctor who helped thousands heal from cancer
Pepsi drops aspartame from diet soda as consumers reject toxic sweetener
Bride of Frankenfood: Hillary Clinton pushes GMO agenda... hires Monsanto lobbyist... takes huge dollars from Monsanto
STATINS RED ALERT: Widely prescribed drugs act as cellular poisons that accelerate aging... deactivate DNA repair... promote diabetes, muscle fatigue and memory loss
Mind control through emotional domination: How we're all being manipulated by the "crisis of the NOW"
Wild eyes and bowl cuts: Why do mass shooters always share the same hair styles and crazed zombie stares?
(NaturalNews) A German drug company has been outed for lying to the U.S. Food and Drug Administration (FDA) and European regulators about the safety of a popular blood-thinning medication. A series of papers recently published in The BMJ explain that Boehringer Ingelheim, maker of Pradaxa (dabigatran), withheld key data about how the drug can accumulate in the bloodstream and cause major health problems, including death.

An investigation by The BMJ's Deborah Cohen found that drug use guidelines for Pradaxa are "flawed" in that they mislead the public about how to safely use Pradaxa. A replacement for an earlier iteration of the medication known as Coumadin (warfarin sodium), Pradaxa bears claims that it is superior because it does not require constant monitoring of plasma levels or anticoagulant activity, and doses of the drug do not need to be adjusted.

But this is apparently not true, according to the investigation, as internal documents released during litigation in the U.S. -- Boehringer recently settled a whopping 4,000 state and federal lawsuits over the drug, agreeing to pay out $650 million in damages -- revealed that Pradaxa does need to be monitored, and doses adjusted, to maximize patient safety.

"Boehringer Ingelheim, the maker of dabigatran, has failed to share with regulators information about the potential benefits of monitoring anticoagulant activity and adjusting the dose to make sure the drug is working as safely and effectively as possible," explains Cohen's BMJ paper. "The company also withheld analyses that calculated how many major bleeds dose adjustment could prevent."

This failure to provide the FDA and European regulators with key information about the drug's safety -- information that may have led to the drug not even being approved -- caused many Pradaxa patients to suffer major bleeding problems. In some cases, patients died due to the false presumption that they could continue taking standard doses of Pradaxa without regular monitoring and adjustment.

Nearly half of all bleeding events, deaths could have been avoided if Boehringer was honest

According to Cohen's analysis, upwards of 40 percent of patients who reported serious bleeding events or who died as a result of taking Pradaxa could have avoided this fate if they had just had regular blood testing. But because of Boehringer's willful deception in the matter, they all suffered needlessly.

It makes sense that a ruthless drug company like Boehringer would lie about something like this, as the supposed benefits of Pradaxa over Coumadin and other anticoagulant drugs was the very basis for the drug's creation and approval. If Boehringer had been honest about Pradaxa from the start, in other words, it would have been obvious that Pradaxa is no better than any other potentially deadly stroke drug currently on the market.

"If monitoring is needed, that advantage goes away," admitted Dr. Srinivas Murali, medical director of Allegheny Health Network's Cardiovascular Institute, to the Pittsburgh Post-Gazette. For now, Dr. Murali plans to cease prescribing Pradaxa and stick to older anticoagulants instead, which include regular monitoring.

Thousands of patients from across the nation had filed separate lawsuits against Boehringer for injuries sustained as a result of taking Pradaxa, the basis of the $650 million agreed settlement. One man from Tennessee, as reported by Drug Watch, was hospitalized for hemorrhage as a result of taking Pradaxa. And even after he stopped taking the drug, he still suffered from internal bleeding due to the medication.

"I thought it would lessen the headache of being on Coumadin," said Roy Heady, a retired electrician from Cookeville, as quoted by USA Today. "But it ended up creating more of a headache."

Sources for this article include:







Follow real-time breaking news headlines on
Blood thinner at FETCH.news
Join over four million monthly readers. Your privacy is protected. Unsubscribe at any time.
comments powered by Disqus
Take Action: Support NaturalNews.com by linking back to this article from your website

Permalink to this article:

Embed article link: (copy HTML code below):

Reprinting this article:
Non-commercial use OK, cite NaturalNews.com with clickable link.

Follow Natural News on Facebook, Twitter, Google Plus, and Pinterest

Colloidal Silver

Advertise with NaturalNews...

Support NaturalNews Sponsors:

Advertise with NaturalNews...


Sign up for the FREE Natural News Email Newsletter

Receive breaking news on GMOs, vaccines, fluoride, radiation protection, natural cures, food safety alerts and interviews with the world's top experts on natural health and more.

Join over 7 million monthly readers of NaturalNews.com, the internet's No. 1 natural health news site. (Source: Alexa.com)

Your email address *

Please enter the code you see above*

No Thanks

Already have it and love it!

Natural News supports and helps fund these organizations:

* Required. Once you click submit, we will send you an email asking you to confirm your free registration. Your privacy is assured and your information is kept confidential. You may unsubscribe at anytime.