Pradaxa Dangers — Why are Americans Always the Last to Know?

In yet another embarrassing moment for our United States regulatory authorities and medical establishment, doctors in New Zealand have written an open letter published in the New England Journal of Medicine highlighting the extreme danger posed by the drug Pradaxa.

As we have written before, Pradaxa is Takeda Pharmaceutical’s solution to the bothersome blood work that Coumadin patients undergo to monitor their blood levels. Both Pradaxa and Coumadin are prescribed to patients who suffer from Atrial Fibrillation or abnormal heart beat. By thinning the blood, these medicines reduce the risk of blood clots forming in the heart. Unlike those who take Coumadin, Pradaxa users do not require regular blood levels checked.

The problem however, for Pradaxa takers is the danger presented when they suffer any bleeding event, medical condition or trauma that requires emergency care or surgery.

Since those taking both Coumadin and Pradaxa have thin blood, any bleeding event such as an ulcer or stroke is a potentially life threatening event. For those taking Coumadin an effective reversal agent exists. Packed red blood cells or vitamin K delivered emergently allows doctors to control the bleeding and to perform emergency surgery. Pradaxa however, has no effective reversal agent. The danger for those taking Pradaxa is a potentially lethal and irreversible bleeding event.

The group of doctors who published the open letter state:

“The serious consequences of the lack of an effective reversal agent should not be underestimated.” They based their comments on a two month study of bleeding incidents including major bleeds and found that, “Prolonged bleeding increased morbidity and possibly contributed to the death of one patient.”

They even found that reduced dosage of the medication in older patients did not reduce the risk of bleeding events.

Unlike the FDA, a group of physicians in New Zealand expressed concern about the possibility of excess bleeding in Pradaxa patients soon after it became available in New Zealand in July 2011. They formed a panel to study the problem and are now publishing their results which are very concerning.

By contrast, Pradaxa has been on the market in the United States for over ten years. The FDA finally got around to “studying the problem” of reported excessive bleeding events in December of 2011.

Why is it that the medical establishment in other countries routinely snuffs out bad drugs and defective medical devices years before the FDA even speaks to these issues. It took doctors in New Zealand less than a year to uncover the dangers of Pradaxa. Within that same year they had studied the problem and are now publishing their findings in one of America’s most prestigious medical journals.

Where are our doctors? Where is the FDA? Americans deserve better.