By Independent Staff Writer
Although only on the market for a relatively short period of time, Pradaxa, the blood-thinning drug manufactured by Boehringer Ingelheim—has already suffered under the weight of threatened recalls, lawsuits and warnings by the FDA. Pradaxa is the first FDA-approved drug of its type since the drug Warfarin was approved in 1954. Both Warfarin and Pradaxa are commonly prescribed as blood thinners to reduce the risk of stroke in patients with heart rhythm irregularities.
Warfarin was used almost exclusively until November of 2005 when Boehringer Ingelheim sponsored a clinical trial to determine the long-term safety and effectiveness of their “new kid on the block,” Pradaxa. The Pradaxa blood-thinning drug trial concluded in March of 2009 to rave reviews. More than 18,000 patients were enrolled in the trial across 44 countries. Boehringer announced that Pradaxa was able to significantly reduce the risk of stroke when compared to the older established drug, Warfarin, and that it had similar or even reduced risks of causing major bleeding in the body—depending on the dosage.
Pradaxa Receives FDA Approval
Pradaxa FDA approval came in October of 2010. The FDA approved Pradaxa as the first anti-coagulant drug approved for the prevention of stroke since the approval of Warfarin. The end of 2010 saw Boehringer Ingelhem Pharmaceuticals aggressively marketing Pradaxa across the United States, touting it as a much more effective alternative to Warfarin. Then, merely three months later, the pharmaceutical company saw the first of what was to be a series of blips on the radar of their new drug which was already adding millions of dollars to their coffers. This first snag was a minor one—the FDA issued a fairly benign alert, stating that Pradaxa must be kept in its original packaging in order to avoid the potential of moisture to cause the drug to break down and lose potency.
Boehringer Reports Increase in Sales
Still riding high in August of 2011, Boehringer reported its business had seen a sixty percent increase in net sales since the launch of Pradaxa in Canada, the United States and Japan. In fact, in less than twelve months on the market, over a million prescriptions for Pradaxa were dispensed to Americans, with nearly 400,000 patients receiving a Pradaxa prescription. Apparently Boehringer should have waited for the announcement of success. Three months later, in November of 2011, Boehringer Ingelheim reported that Pradaxa had been linked to 260 deaths worldwide, then the FDA issued a safety review of Pradaxa in December of 2011. At the end of 2011 the FDA reported they were evaluating reports of serious or even fatal uncontrolled internal bleeding incidents among Pradaxa blood-thinning drug patients.
Side Effects of Warfarin vs. Pradaxa
Although Warfarin is well-known by health care professionals to sometimes cause excessive bleeding there is a major—and significant—difference between the drugs. In an emergency which involves excess bleeding there are currently no medications known which can reverse the effects of Pradaxa, while in an emergency involving Warfarin, the effects can be reversed by giving the patient Vitamin K. The downside of Warfarin is that it requires several days to take effect and the patient taking Warfarin must undergo frequent testing to arrive at the proper dosage. Warfarin has also been known to react poorly with specific foods or other medications. While Pradaxa has none of these issues, Pradaxa patients are considered to have a 33% higher risk of a heart attack or other heart disease symptoms than the patient using Warfarin. Most alarming, however, is the potential with Pradaxa for excessive bleeding which cannot be stopped, possibly leading to death.
What is the FDA Doing About Pradaxa?
The FDA is currently conducting studies to determine whether the reports of excessive bleeding among patients who are taking Pradaxa is more common than previously expected. The FDA continues to assert that Pradaxa provides important health benefits when used as directed. These studies become more complicated since a wide variety of factors can influence whether or not adverse side effects are reported. After the FDA announced their intent to study the side effects of Pradaxa prior to making a recall determination, findings from a new study were published in a well-known medical journal which suggested there could be an increased risk of heart disease in patients taking Pradaxa as compared to Warfarin.
To date, the FDA has received over 900 reports of serious negative side effects involving Pradaxa as well as reports of 500 hospitalizations and the permanent disability of twenty-five people as a direct result of Pradaxa use. The Journal of the American College of Cardiology released a study showing Pradaxa users had a 16% increased risk of severe bleeding while Warfarin users had only a 6% increased risk.
No Recall, Lawsuits Filed
Although the FDA has not yet issued a recall, they do strongly advise any person taking Pradaxa who has experienced any negative side effects to see their physician immediately. Side effects can include bruising more easily than normal, dizziness or feelings of lethargy, a serious or prolonged headache, vomiting or coughing up blood, unusual or prolonged nosebleeds or bleeding from the gums, urine which is pink or brown-tinged or a weakness or swelling in the extremities. Just this month, the first three Pradaxa lawsuits have been filed, one of which claims the death of a Tennessee woman who suffered a gastrointestinal bleed while taking Pradaxa.
What You Should Do if You Take Pradaxa
Those patients who have put their belief and trust into a drug which has FDA approval and is physician-prescribed can end up feeling confused and overwhelmed when that same drug turns out to be unsafe and is found to cause serious, life-threatening side effects. Many people have suffered serious health issues as a result of taking Pradaxa—if you or a loved one has also suffered such issues you must take steps now to protect your rights and your future. Drug companies must be held accountable for allowing dangerous drugs to flood the market.
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