Tag: U.S. Food and Drug Administration

WEDMD PHOTO | Coumadin, a blood thinner, can be difficult for doctor’s to prescribe effectively.

Blood clots can cause strokes, heart attacks or pulmonary embolism. But blood clotting can be beneficial, preventing or stopping bleeding during trauma.

Achieving a balance of both scenarios is critical.

For almost half a century, physicians treating patients with dangerous blood clots have had one type of oral medication to prescribe — the anticoagulant warfarin, more commonly known by the brand name Coumadin.

But health experts say it can be difficult to prescribe this drug effectively, as it easily interacts with a patient’s diet.

Within the past five years, the study of anticoagulants has become a hot topic in the medical field, sparking U.S. Food and Drug Administration approval of three new medications: Pradaxa (dabigatran etexilate), Xaralto (Rivaroxaban) and Eliquis (apixaban). Another option, Edoxaban, is awaiting FDA approval.

Patients and providers now have alternative treatment options, each with its own benefits.

“These new drugs have been shown to be as effective as warfarin, if not more effective, and they are remarkably safer when it comes to serious bleeding,” said Dr. Christian Ruff, a professor at Harvard Medical School who is helping to conduct clinical trials of Edoxaban, which involve over 21,000 patients from 46 countries.

While many people refer to anticoagulants as “blood thinners,” they do not actually thin the blood. Instead, they cause the blood to take longer to form a clot — something that’s undesirable in an emergency situation.

More than a third of patients at risk for a dangerous clotting event aren’t given the medication because of the fear of serious bleeding, Dr. Ruff said.

Warfarin, which costs pennies a pill, was initially created as a rat poison back in the 1940s. It was approved for human use in 1954 and, after suffering a heart attack while in office, President Eisenhower became one of the first patients to receive it, Dr. Ruff said.

The drug works by interfering with your body’s use of vitamin K, which creates clotting factors and prevents bleeding. But vitamin K is a naturally occurring nutrient present in many leafy green vegetables, Dr. Ruff said, and when ingested can affect the impact warfarin has on the body.

“It is certainly the most difficult and the most dangerous drug used in clinical practice,” he said.

The new medications inhibit clotting in different ways and are not dependent on vitamin K, enabling them to cut life-threatening bleeding by half compared to warfarin, Dr. Ruff said.

Researchers are still researching what they call an “antidote” to these new drugs — a treatment administered to reverse their clot-inhibiting effects in the event of an emergency.

“I think there’s been a bit of confusion about the reversal of these drugs, and the best thing to consider is prevention,” he said. “Would you rather cause double the amount of life-threatening bleeding and pray that you can reverse it or prevent half the amount of life-threatening bleeding in the first place?”

Dr. Ruff added that there is no true reversal agent for warfarin.

While the new options may ease a patient’s fear following a fall or accident, they can place added pressure on the budget, as the medications can be more expensive than warfarin, Dr. Ruff said.

“As more patients use these drugs, the volume goes up and the amount that companies charge per prescription will go down,” he said, adding that until then, the best option is what is affordable to a patient given the risks.

Got a health question or column idea? Email Carrie Miller at [email protected]. Follow her on twitter @carriemiller01.