Pradaxa Bleeding Reports To FDA Pass 500

Pradaxa bleeding reports to the U.S. Food and Drug Administration (FDA) have exceeded 500. Pradaxa, made by Boehringer Ingelheim, was approved by the FDA in October 2010 and is used to prevent strokes in people with atrial fibrillation.

The most recent report, said Pharmalot, reveals that 505 cases of hemorrhage were reported to the agency in 2011’s first quarter. The cases involved death, disability, hospitalization, and other significant outcomes, said Pharmalot. The median patient age was 80—25 percent were 84 years of age and older—adding to concerns that older patients are at greatest risk for hemorrhaging over Pradaxa overdose, according to the QuarterWatch report from the Institute for Safe Medicine Practices (ISMP).

We just wrote that a recently published analysis of Pradaxa clinical trials found that patients taking the blood thinner have a higher risk for heart attacks and chest pain. Pradaxa was expected to be adopted as a replacement for warfarin, which can have dangerous interactions with certain foods; however, in recent months, concerns have been mounting about potentially dangerous Pradaxa side effects.

Most recently, for example, the FDA said it was conducting a safety review of Pradaxa aimed at determining if serious bleeding is occurring in Pradaxa patients more commonly than would be expected. In its Drug Safety Communication, the agency said it was evaluating post-marketing reports of serious bleeding events in patients taking the blood thinner, but did not indicate how many such reports it had received.

Just prior, Boehringer Ingelheim, revealed it had received 260 reports of fatal bleeding among Pradaxa patients worldwide, including 21 in Europe. The events occurred between March 2008 and October 31, 2011.

The large study used to gain approval of Pradaxa did hint at a small increased risk of heart attack among people taking the medication. Since, researchers have been trying to determine if Pradaxa does pose an increased risk.

We recently wrote that a recent Pradaxa study, published in The Archives of Internal Medicine, consisted of an analysis of seven earlier clinical trials for the drug involving more than 30,000 people taking Pradaxa, warfarin, enoxaparin, or a placebo. Of 20,000 Pradaxa patients, 237 had a heart attack or chest pain, versus 83 patients out of 10,514 on one of the other drugs, or a placebo. The study also found that Pradaxa boosted the risk of a heart attack and a condition known as acute coronary syndrome by 33 percent. The added risk for any one individual of having a heart attack, if on Pradaxa—known as the absolute increased risk—was 0.27 percent. According to Pharmalot, the analysis indicated that Pradaxa was “significantly associated with a higher risk” of heart attacks and acute coronary syndrome.

ISMP said that the findings suggest that the agency should take another look at Pradaxa dosing, pointing out, said Pharmalot, that in the first quarter of last year alone, 272,119 prescriptions were dispensed to outpatients, with 932 serious adverse events reported, including 120 deaths, 25 cases of disability, and 543 cases needing hospitalization.

According to ISMP, Pradaxa was approved at a dose of 150mg twice daily; however, frequent lab tests to manage the drug—such as what is seen in warfarin—were not recommended, wrote Pharmalot. Also, declining or impaired kidney function is a potential safety issue; however, prescribing information has no recommendation on dosing adjustment in anything but severe renal impairment, and offers no recommendation for regular renal function testing, said ISMP.