New blood thinners such as Eliquis can lead to uncontrollable bleeding problems.

Bristol-Myers Squibb and Pfizer manufacture Eliquis, generically known as apixaban.

Eliquis and other new blood thinners, including Xarelto and Pradaxa, have been marketed as superior to older blood thinner Coumadin (warfarin).

These new blood thinners are once daily oral medications that do not need patient monitoring like Coumadin does.

Are the New Blood Thinners Superior?

The new blood thinners have been touted as superior because they are single-dose daily pills that do not require blood level monitoring.

They have been marketed as a one-size-fits-all answer to those in need of an anticoagulant.

Dr. Curt Furberg is a medical advisor to the Institute for Safe Medication Practices (ISMP), a nonprofit organization dedicated to educating the healthcare community and the public about medication safety.

Dr. Furberg says that the new blood thinners have a wide variation of clot-preventing effects, depending upon the patient.

Research shows that while one of the new blood thinners might work well for some patients, the same dose might be too low to effectively stop a blood clot from forming or it might be too high and cause excessive bleeding in other patients.

Eliquis Had a Rough Road to FDA Approval

Eliquis was the last of the new blood thinners to be approved by the FDA, and its approval process was rocky.

Its clinical trial known as ARISTOTLE (Apixaban for Reduction in Stroke and Other Thrombotic Events in Atrial Fibrillation) was wrought with problems.

There were accusations of alleged cover-ups, unreported serious adverse events, and patients who received the wrong medication.

The FDA said that the drug’s clinical trial issues showed problems that demonstrated a “pattern of inadequate trial conduct and oversight.”

The FDA faulted the study for containing inaccurate data, and the data in the English version did not match the data presented in the Chinese language.

The FDA approved Eliquis in December 2012 after deciding other clinical trial results adequately showed the drug’s effectiveness.

New Blood Thinners and Bleeding Problems

New blood thinners Eliquis and Xarelto have no antidote. If a patient is taking either of these anticoagulants and starts to have uncontrollable bleeding, there is little a doctor can do.

Pradaxa maker Boehringer Ingelheim introduced an antidote for Pradaxa called Praxbind, which became available on the market in the fall of 2015. Prior to that, there was no way to stop internal bleeding of Pradaxa patients.

The old standby blood thinner Coumadin can have its anticoagulant effects reversed by introducing vitamin K.

Patients who suffered from internal bleeding while on Coumadin or warfarin had a way to reverse the bleeding, while many patients on the new blood thinners still do not, and many are questioning the safety of these new medications.