Published on:

House Committee Investigating Safety of Warfarin

For decades, Warfarin (Coumadin) has been the gold standard drug for atrial fibrillation (Afib) patients to avoid being at a higher risk for stroke and other potentially deadly medical conditions like a pulmonary embolism (PE).

courtroom-1-1207444-mWhile Warfarin is considered relatively safe, it does require patients to have frequent monitoring by their physicians to make sure the dosage is correct. This means the patients need to regularly have blood taken to determine how the blood thinner is working. If the dosage is off, it can result in serious medical conditions, including bleeding disorders. While this is a risk, with proper monitoring, it should not occur, and, if it does occur, doctors can often reverse the effects of the drug.

A few years ago, Pradaxa, Eliquis, Xarelto, and more recently, Savaysa came on the market with their respective makers, all claiming their drugs were safe alternatives to Warfarin and they were much easier to take because the dosage was generally the same for all patients, and there was no need for frequent blood tests. This sounded great to many patients, and they switched to one of these new oral anti-coagulants (NOACs) instead of continuing to take Warfarin. New patients chose to start with these NOACs rather than take the relatively safe Warfarin.

The problem, as our Boston Pradaxa injury attorneys can explain, is that these drugs were not perfectly safe alternatives. These drugs are now known to cause a serious internal bleeding condition, including intracranial bleeding, in some of the patients on the drugs. To make matters worse, there is no FDA-approved antidote on the market, and there is no way to tell if a new patient is one of the patients likely to develop the deadly bleeding disorder. While the drug companies claim it is a relatively low number of patients who will experience internal bleeding, since it is a deadly disease for which there is no cure, the fact those thousands of patients who are still sick or have died are a small percentage of all NOAC users is of consolation to nobody.

Since sales are somewhat declining as a result of public awareness of the serious complication, drugs companies and their lobbyists seem interested in getting Congress and the United Stated Food and Drug Administration to reexamine whether Warfarin is as a safe as everyone believes.   Essentially, since they claim in good faith their respective drugs are not causing deadly internal bleeding incidents, they are getting Congress to question Warfarin safety.

According to a recent news article from RAPS, the House Committee on Energy and Commerce is now seeking information from the FDA and Health and Human Services (HHS). The committee claims it is aware of a high number of adverse events related to Warfarin, especially in regard to nursing home patients. Doctors have used Warfarin to treat patients in need of an anticoagulant or blood thinner since 1954, however it is only now the House committee is interested in the drug.   It seems extremely likely the drug companies, through their lobbyists, are asking Congress members to take action against their competitor.

If you are the victim of illness due to taking Pradaxa, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.

Additional Resources:

House Committee Seeks More Info from FDA on Safety of Blood Thinners, September 4, 2015, RAPS, by Zachary Brennan

More Blog Entries:
FDA Announces Testosterone Meds Must Carry Broader Warning, July 7, 2014, Boston Products Liability Lawyers Blog