Since November 2011, at least 260 deaths worldwide have been linked to new blood thinner Pradaxa. An estimated 1.1 million prescriptions have already been written for Pradaxa, and 371,000 patients are currently taking the drug.
Serious Bleeding Events
Pradaxa was approved by the Food & Drug Administration (FDA) in October 2010 to reduce the risk of blood clots and strokes in patients with non-valvular atrial fibrillation. Just over a year after being approved, the FDA issued a safety communication for Pradaxa, warning consumers that patients taking the drug have reported experiencing serious bleeding events.
Symptoms of these adverse events include the following:
- Persistent nose bleeding
- Unusual gum bleeding
- Vomiting or coughing up blood
- Heavier than normal menstrual bleeding
- Red or black stool
- Pink or brown urine
- Severe or uncontrollable bleeding
The FDA recommends that if you or a loved one experiences any of these symptoms, you seek the help of a health care provider immediately.
Can We Trust the FDA?
Although the FDA is currently investigating claims that Pradaxa has caused serious bleeding, the agency maintains that "[a]t this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label.”
The FDA has made statements like this before for drugs that were later proven to indeed be very dangerous. Patients taking Avandia, for example, reported adverse events like heart attacks. The FDA had approved Avandia in 1999 simply because it helped diabetics to control blood sugar levels. But after nearly 47,000 people taking Avandia suffered a heart attack, stroke, or even death, the FDA finally restricted the use of the drug in 2010.
More recently, the FDA has received criticism for allowing experts with conflicts of interest to sit on a panel to determine whether the popular birth control pills Yaz and Yasmin should be taken off the market. At least four of the experts on the panel had received compensation from Yaz and Yasmin’s manufacturer Bayer. All of them voted in favor of keeping the pills on the market.
And it seems as though the FDA may be behind the curve on Pradaxa. Both Japan and Australia have issued safety warnings, linking Pradaxa to serous bleeding events.
To learn more about the pharmaceutical industry and why the FDA approves these dangerous drugs, download my FREE e-book Prescription Drug Safety: 7 Secrets the Pharmaceutical Industry Does NOT Want You to Know at www.vanweylaw.com today.