Pharmaceutical

Study finds Pradaxa could make common falls lethal for elderly

The death of an 83-year-old man who checked into The University of Utah’s hospital after suffering from a routine fall raises concerns that hemorrhaging may be irreversible in patients taking Boehringer Ingelheim’s blood-thinning drug Pradaxa.

A new report published Thursday in the Journal of Neurosurgery, authored by physicians in the University’s Neurosurgery Department who treated the patient, details his decline and eventual death hours after arriving at the hospital. The patient went to the hospital after experiencing a standing-level fall that left him banged up but alert and coherent. The study notes that one month prior to his fall, the patient’s primary care physician put him on a regimen 150 mg of dabigatran (the clinical name for Pradaxa) twice daily to treat his irregular heartbeat.

Initial scans showed the patient was bleeding heavily in his brain. According to the report, “Approximately 2 hours after admission to the intensive care unit, the patient developed dysarthric speech, although he was still able to briskly follow commands.” After six hours the man lapsed into a coma and died shortly after. Subsequent scans revealed that blood had flooded the left side of his brain and a large portion of the right.

The study’s authors note that the U.S. Food and Drug Administration’s (FDA) approval of Pradaxa in October 2010 “presents a new dilemma for neurosurgeons” because “imbalance and falls are common (in elderly patients), and intracranial hemorrhage resulting even from minor trauma may occur with increasing frequency as use of this drug becomes more widespread.”

The concern is especially valid because the FDA is about to approve similar drugs, which could potentially lead to more unstoppable bleeding and deaths in patients who suffer from routine falls.

Clinical studies have shown that Pradaxa can be more effective at reducing the risk of stroke than other blood thinners in some patients, and it’s easier for doctors to administer than warfarin, the leading blood thinning drug, because it has fewer interactions with food and other drugs. It also doesn’t require monthly blood tests to adjust the dose.

However, the problem is that no agent currently exists to stop hemorrhaging in patients taking Pradaxa, making bleeding practically irreversible. Patients can only be treated with kidney dialysis to remove the drug from their blood, but the process generally takes hours, rendering it ineffective in a hemorrhaging emergency. Bleeding can typically be controlled in patients taking Warfarin with injections of vitamin K.

After conducting an analysis of data from the FDA’s Adverse Event Reporting System in the first quarter of 2011, the Institute for Safe Medicine Practices said a “review of [dabigatran’s] adverse effects in high risk patients deserves to be a national priority.” The analysis found “932 serious adverse events were linked to this drug, including 120 deaths, 25 cases of permanent disability, and 543 cases requiring hospitalization.”

Additionally, dabigatran was linked to 505 cases of hemorrhaging – more than any other drug and nearly three times as much as warfarin, which ranked second.

For more information, see www.pradaxa-claims.com.

Sources:

The Journal of Neurosurgery

The Salt Lake Tribune

Reuters