Pradaxa and Xarelto Bleeding Side Effects Worries Doctors

There are now 2 new drug alternatives for stroke prevention in millions of heart patients who suffer with Atrial Fibrillation. The condition affects about 3 million Americans, causing blood to pool in a storage chamber of the heart (atrium), where it can form a clot and travel to the brain.

These new blood thinners are the first replacements in 60 years for warfarin/coumadin, which was the gold standard anticoagulant pill.

But there is growing complaints of bleeding risks and deaths, most concerns involve Pradaxa, a twice daily pill from Boehringer Ingelheim that was approved by the U.S. Food and Drug Administration in October 2010 to prevent strokes.

Pradaxa Bleeding Bad News

According to Dr. Alan Jacobson, director of anti-coagulation services at the Veterans Administration (VA) healthcare system in Loma Linda, California, "the good news is you now have an alternative to warfarin, the bad news is you can kill a patient as easily with the new drug as you could with the old drug if it is not handled properly."

Xarelto Side Effects

Xarelto, is a once daily pill from Johnson & Johnson was approved last November for atrial fibrillation.

Coumadin/Warfarin Risks

The risks of warfarin, as with any anticoagulant, include brain hemorrhages and other dangerous bleeding. Patients taking warfarin require close monitoring and regular blood tests as well as dietary and lifestyle changes.

Safe Medication Practices Report

The nonprofit Institute for Safe Medication Practices estimated that 542 reports of deaths associated with Pradaxa were reported to the FDA in 2011, topping all other medicines, including warfarin, with 72 deaths. Adverse event reports on Xarelto were not available.

Pradaxa in the spotlight with European Regulators

European regulators have instructed Boehringer Ingelheim to add warnings about the bleeding risk to Pradaxa's package insert. Almost two dozen U.S. federal lawsuits have been filed against Boehringer Ingelheim alleging harm from Pradaxa.

Cost of Pradaxa and Xarelto

About 130,000 U.S. prescriptions were written for Xarelto in the first three months of 2012. Pradaxa and Xarelto each cost about $3,000 a year, versus just $200 for generic warfarin.

Pradaxa and Xarelto Risks and Warnings

According to U.S. heart doctors, neither new drug has a known antidote for a bleeding emergency, unlike warfarin.

They also say that patients using them should undergo testing ahead of time to ensure good kidney function, be carefully taught potential pitfalls of the drugs and be seen by doctors periodically, especially after a switch is made.

Many doctors fail to test patient kidney function before prescribing Pradaxa, 80 percent of the drug is excreted via the kidney.

Impaired kidney function or renal failure allows the drug to build to unsafe levels in the bloodstream. About two thirds of Xarelto is eliminated by the kidneys. Sometimes doctors failed to ask patients whether they had a history of gastrointestinal bleeding, which raises the risk for Pradaxa.

Pradaxa and Xarelto Mechanism of Action

Warfarin thins the blood by blocking Vitamin K, while Pradaxa directly inhibits thrombin – a protein involved in clotting. Xarelto and Eliquis – which Bristol-Myers is developing with Pfizer Inc – interferes with a protein called Factor Xa.

Eliquis is eliminated mainly by the liver, which some doctors say could make it more appropriate than Pradaxa or Xarelto for older patients and those with kidney problems. The FDA is expected to make a decision on Eliquis by June 28.