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Blood thinner drug manufacturer withheld critical safety data from FDA


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(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:

http://www.bmj.com

http://www.techtimes.com

http://www.drugwatch.com

http://www.post-gazette.com

http://usatoday30.usatoday.com

http://science.naturalnews.com

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