Is Coumadin on the Way Out?

Seattle, WABecause it has been around for so many years, Coumadin was widely regarded as the gold standard for anticoagulant medications. New medications have come along to replace Coumadin, claiming to not carry the same risk of Coumadin side effects - or the same need for blood monitoring. But because Coumadin (known also as warfarin) has an antidote, it has survived competition from the newer drugs.

Coumadin is an anticoagulant used to prevent blood clots, which can lead to strokes. To be prescribed Coumadin, however, patients have to have blood monitoring to ensure their levels stay within certain guidelines. This monitoring can affect a person’s life, because it must be done at regular intervals. Furthermore, because Coumadin prevents blood clots, it affects a person’s blood-clotting ability, meaning a relatively minor bleeding event can quickly turn serious. This issue could be made even worse by the use of certain non-steroidal anti-inflammatory drugs (NSAIDs), which can interact with anticoagulant medications.

What sets Coumadin apart from other anticoagulants, however, is that there is an antidote to the drug. If a patient experiences a bleeding event and gets to a hospital quickly enough, the patient can be given vitamin K to counteract the anticoagulant and get the bleeding under control. Newer anticoagulant medications do not have an approved antidote.

That may be about to change. Pradaxa, one of the newer-generation anticoagulants may soon have an approved antidote. Boehringer Ingelheim has announced idarucizumab, a potential antidote to Pradaxa that is on the FDA’s fast track for accelerated approval. This would mean that Coumadin would no longer be the only anticoagulant with an antidote.

Lawsuits have been filed against the makers of many newer anticoagulant medications, alleging patients were not warned that the new medications - unlike Coumadin - did not have a proper antidote. As of April 15, 2015, there were more than 1,600 Pradaxa lawsuits consolidated before US District Judge David Herndon in MDL 2385, in the Southern District of Illinois.

Among side effects that have reportedly been linked to the use of Coumadin are dangerous interactions with other medications, a potential increased risk of birth defects when taken by a pregnant woman, unusual bleeding or bruising, and increased risk of hemorrhagic stroke.

When exactly Pradaxa’s antidote will be available is not yet known.