In general, anticoagulants are prescribed to patients with atrial fibrillation and to patients who recently underwent knee or hip replacement surgery and may be in danger of blood-clotting in the surgical or hip area. Today, the anticoagulant market has more treatment options now than it has in the past century, with Eliquis only joining the market in 2012.

Eliquis had been approved to treat deep vein thrombosis and pulmonary embolism, both major clotting conditions in patients who recently underwent the mentioned surgeries, in 2014.

Deep vein thrombosis occurs when a blood clot forms in a large vein, usually in the lower leg, thigh, or pelvis. This condition can evolve into pulmonary embolism, at which point a portion or all blood clots start affecting the body by traveling to the lungs and blocking one or more blood vessels.

Both conditions can lead to sudden cardiac death. Eliquis and other anticoagulants work by blocking certain proteins that cause these clotting conditions.

When it was approved in 2012, Eliquis already had numerous patients with atrial fibrillation requesting it to prevent stroke; it gained further followers when it was approved to prevent certain clotting conditions.

Hip and knee surgeries are some of the most common procedures performed in the United States, with 719,000 knee surgeries and 332,000 hip replacements each year, and keeps increasing at an annual rate. It is unfortunate, but blood clotting is horribly common after these surgeries because major veins and arteries surround the areas.

For hip and knee-replacement surgeries, the risk of developing blood clots is highest in patients without thromboprophylaxis, so it is ultimately recommended that patients are prescribed Eliquis or another blood thinner before and after the surgery.

For Eliquis’ to obtain approval to treat blood clotting in hip and knee surgeries, it had gone through the FDA’s ADVANCE clinical trial program, which randomized more than 11,000 patients with 5,700 of them receiving Eliquis. After receiving positive results, the FDA accepted the review and results in December 2013, and officially approved the drug for those uses in mid-2014.

The need for anticoagulants has been present for decades, and had only gained one drug in the 1960’s with the release of Warfarin. Before the release of Pradaxa in 2010, Warfarin was the only anticoagulant available to patients.

The release of Pradaxa had been significant to patients and the medical community because the elusive anticoagulant market had been breached. It had been a successful venture for the manufacturing company, Boehringer Ingelheim, and had inspired other pharmaceutical companies to try and break into the market as well.

A year after the release of Pradaxa, Xarelto joined the market in a joint venture between Bayer Pharmaceuticals and Johnson & Johnson’s subsidiary, Janssen Pharmaceuticals. They have arguably been the most successful, as Xarelto soon dominated the anticoagulant market. Now Pfizer and Bristol-Myers Squibb are trying their luck in the harsh market, and have seen positive results from Eliquis since its approval in 2013.

With so many treatment options now available, it should be more reassuring to patients who may be at high risk for developing these clotting conditions. Unfortunately, there is an inherited risk in using anticoagulants that, many experts argue, outweighs their benefits.

Overview of Anticoagulant Bleeding Risk

Every anticoagulant comes with the risk of uncontrollable internal bleeding, but only one of them has an established stopping agent. While the newer anticoagulants have been advertised to be faster-acting and hassle-free for patients, they have come with an inherent risk of internal bleeding because they do not have a reversal agent.

At issue is that the labeling is reportedly not sufficiently explaining the risks. Even if Warfarin is slower, experts have been recently recommending this drug over its younger counterparts because it requires patients to frequently see their doctor, have frequent dose adjustments, and instructs patients to apply vitamin K to stop any internal bleeding events.

However none of the new-generation anticoagulants, Eliquis and the others, come with these precautions as they are prescribed in a constant dose and do not require patients to check-in with their doctors. While there are currently two reversal agents in the works for these newer anticoagulants, they are currently not available to patients. If patients suffer an internal bleeding event, they will most certainly have to be hospitalized for emergency intervention.

Many patients have complained that they were not adequately warned of the risks associated with Eliquis and other new anticoagulants. Even patients with hip and knee surgery have to weigh the risks between cardiac death and internal bleeding.