According to ABC 7 Detroit, Pradaxa, a popular blood thinner, is the most complained about drug in the United States.
Pradaxa is used to treat atrial fibrillation, a heart condition that significantly increases the risk of stroke. Research found more complaints were filed with the Food and Drug Administration (FDA) about Pradaxa than any other prescription drug, in both 2011 and 2012.
“We’ve found that this drug had a potential benefit in preventing stroke, but it also had extremely high risk of bleeding,” stated Tom Moore, the senior scientist at the Institute for Safe Medication Practice. The ISMP is a non-profit organization that monitors FDA reports.
As we blogged about before, in February, 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 than others. One of Pradaxa’s main selling points is that the drug does not require regular blood tests to ensure it’s working, but the documents also showed that the company knew daily blood testing could help manage the bleeding risk, but did not notify consumers.
“It’s a great tragedy…in the regulation of drugs. There was an opportunity to make it safer, instead it appears the commercial instincts to sell more drugs won out,” Moore added. “This drug now needs to be reassessed and it’s not clear that it is safe.”
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If you or a loved one developed a serious injury or condition after taking a pharmaceutical drug or using a medical device, contact our injury lawyers today by calling (305) 476-7400. For no charge, you can find out if you have a potential case. We represent clients nationwide.
Did You Know: Since it was approved by the FDA in 2010, Pradaxa has been blamed for 1,158 deaths in the US and 12,494 serious injuries.
Colson Hicks Eidson – Injury Attorneys