Wednesday, February 19, 2014

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Investigation: Pradaxa most complained about U.S. drug; blamed for deaths, life-threatening injuries

CLEVELAND - A Five On Your Side Investigation found Pradaxa, a popular blood thinner,  is the most complained about drug in the United States.

Our research found more complaints were filed with the FDA about Pradaxa than any other prescription drug in both 2011 and 2012.

Since it was approved by the FDA in 2010, Pradaxa has been blamed for 1,158 U.S. deaths and 12,494 serious injuries, according to Tom Moore, the senior scientist for drug safety and policy at the Institute for Safe Medication Practices. The ISMP is a non-profit organization that monitors FDA reports.

The drug is used to treat atrial fibrillation, a heart condition that significantly increases the risk of stroke.

"We've found that this drug had a potential benefit in preventing stroke, but it also had extremely high risk of bleeding as do some other anti-coagulants,” said Moore.

Court Order Reveals Hidden Documents

Earlier this month, as the result of an Illinois court order, documents were released that revealed the drug’s manufacturer, Boehringer Ingelheim, performed a study that showed a small minority of patients could have a higher bleeding risk.

The documents also show the German based company knew regular blood tests could help manage the bleeding risk.

However, in an internal e-mail obtained by 5 On Your Side Investigators, a supervisor expressed concern requiring monitoring could hurt sales.

Dr. Jutta Heinrich-Nols writes “Is it really wanted to publish this?” and “This will make any defense of no monitoring . . . extremely difficult . . . and undermine our efforts to compete (with other blood thinners.)”

The FDA approved with no requirement for regular monitoring.

"It's a great tragedy in medicine in the regulation of drugs,” said Moore.

"There was an opportunity to make it safer, instead it appears the commercial instincts to sell more drugs won out,” he said.

“This drug now needs to be reassessed and it's not clear that it is safe,” he said.

Northeast Ohio Patient Discuss Injuries

Inez Brest, 71, agrees. The Amherst grandmorther suffered a severe cerebral hemorrhage last April after taking Pradaxa a few months.

 "All of a sudden, I had this huge, like it sounded like it went ‘Pow!’ It was like my brain exploded, she said.

“My head was on fire. It was a real god awful feeling. It was like it was burning in there,” said Brest.

Brest now uses a walker and has significant memory loss. “I miss my brain,” she said.

Michael Timko, 67, of Lorain also blames Pradaxa for his injuries.

He has become homebound after experiencing a gastrointestinal hemorrhage in April 2012.

"Even my worst enemy, i wouldn't want to put them in the position I'm in right now,” he said

His wife, Jean, said her husband is completely dependent on her and their daughter.

"He can't take our grandson fishing, that's the one thing he's talked about. He'd love to take Mikey fishing and he can't take Mikey fishing,” she said.

"He doesn't deserve the life he's living now,"  she said.

Brest and Timko are among 2,304 former Pradaxa users who have filed lawsuits in federal court against Boehringer Ingelheim for failing to warn them.

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