A team of leading New Zealand hematologists are turning to the New England Journal of Medicine to reignite concerns about a blood thinner used in heart patients. The medical experts say that the trial used to assess the safety of the drug Pradaxa is questionable and that there is research showing the medication can cause prolonged bleeding events, particularly in elderly and underweight patients with renal problems.
The team of experts says that high risk patients were not properly represented in safety trials conducted by the drug’s maker, Boehinger Ingelheim, and that prolonged bleeding caused by Pradaxa may likely have contributed to the death of at least one patient last year.
“We are concerned that the potential risks of this medication are not generally appreciated,” the team was quoted in the medical journal.
Pardaxa, also known as dabigatran, is a blood thinner that is used to prevent blood clots that can cause strokes in patients with certain heart problems. Unlike other blood thinners, like warfarin, there is no antidote to reverse its effects in the event of a bleeding emergency. While bleeding is an expected side effect from most blood thinners, the team of hematologists say that the bleeding risk with Pardaxa is compounded by age, poor kidney function, and low body weight.
According to the new data, during the first two months of use, 78 episodes of bleeding were reported in patients, 16 of whom required a blood transfusion or surgery. In a quarter of those cases, prescriber error was to blame. Two thirds of the patients were over the age of 80, 58 percent had moderate or severe renal impairment, and approximately half weighed less than 130 pounds.
Source: Manawatu Standard