Monday, June 4, 2012

Regulatory History of Pradaxa

Pradaxa First Marketed as a Thrombin Inhibitor

Boehringer Ingelheim announced in March of 2008 that the European Commission had granted approval to market their new oral thrombin inhibitor known as Pradaxa 27 EU states. At this juncture it was expected that Pradaxa would soon be released in Germany and the UK as well. Pradaxa was approved at this time for the prevention of venous thromboembolic events in those who experienced hip or knee replacement surgery.

The risk of life-threatening blood clots following orthopedic surgery is a major concern, and there has long been a need for an effective oral with a good safety profile other than Warfarin. While patients typically received Warfarin following orthopedic surgery up to this point, Warfarin is known for its extensive interactions with other drugs and foods as well as for the need for constant blood testing. For use following orthopedic surgeries, Pradaxa demonstrated good levels of efficacy and safety and the company noted that Pradaxa had a rapid onset in the anticoagulation effect while exhibiting no drug/food interactions.

FDA Approval

In the fall of 2010, the United States FDA approved Pradaxa for use in inhibiting strokes and blood clots in those who suffer from atrial fibrillation or abnormal heart rhythms. Atrial fibrillation affects over two million Americans and is one of the most ordinary types of irregular heart rhythms although those with the disease suffer a much greater risk of having blood clots. Pradaxa’s safety as well as how well it works were studied in a clinical trial which put Pradaxa up against Warfarin, a drug which had been in use since the early 1950’s. In this trial, those taking Pradaxa exhibited less strokes than those on Warfarin. The most common adverse reaction to Pradaxa appeared to be uncontrolled bleeding which in some cases was life-threatening or fatal. Some Pradaxa patients experienced GI symptoms such as stomach pain, heartburn, nausea and bloating. The FDA approval required an accompanying medication guide to inform patients of potential bleeding risks.

Further Regulatory Events

March of 2011—less than six months after approving Pradaxa, the FDA issued a minor alert to patients which only stated that Pradaxa needed to be kept in its initial packaging to prevent loss of potency. In August of 2011, the Japanese Ministry of Health and Welfare asked Boehringer Ingelheim to provide a letter to doctors detailing the specific bleeding risks of Pradaxa particularly in patients older than 75. This request was issued following the deaths of fourteen elderly patients from excess hemorrhaging. A short month later New Zealand officials reported excessive bleeding risks in those taking Pradaxa.

In the first year after its release over a million Pradaxa prescriptions were written with over 400,000 patients receiving the drug. In October of 2011—a year after Pradaxa burst onto the American Market—the European Medicines Agency recommended labeling changes which would advise renal assessments prior to taking Pradaxa as well as caution against high dosages in the elderly population. One month later the U.S. recommended a similar label change regarding the risks of Pradaxa administration in those who suffer renal impairment. The FDA stated they would be evaluating Boehringer’s post –marketing reports of serious bleeding events in those taking Pradaxa.

The FDA in 2012

The first month of 2012 the FDA requested that Boehringer change the Pradaxa label to increase the risks and warnings in those who are suffer renal impairment. They further asked that the word “antidote,” (as in there is no antidote) be moved to the warning section on the labeling insert. Finally, the FDA asked that Boehringer state the increased risk of bleeding events on their label. The FDA has been given over a thousand claims of serious adverse effects involving Pradaxa not to mention over five hundred hospitalizations , the permanent disability of at least two dozen Pradaxa patients and it has believed that as many as 250 Pradaxa patients have died from bleeding out. While the FDA is hedging on issuing a recall of Pradaxa they have advised those taking Pradaxa to see their physician immediately in the event of adverse side effects. It is believed that the adverse events related to Pradaxa will continue to happen since there is no known antidote to Pradaxa in the case of severe bleeding.

Author: Sullo & Sullo Attorneys

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