Pradaxa, the warfarin alternative from Boehringer Ingelheim, is again under fire only weeks after the FDA released information that the blood thinner was at least as safe as the drug it seeks to supplant. Authorities in Australia are reconsidering their recommendation for its use there, and the FDA just sent out a new medical alert warning against using the blood thinner on patients with mechanical heart valves.
The Pharmaceutical Benefits Advisory Committee (PBAC) in Australia says that based on new data, it is reconsidering its recommendation that the government cover the cost of the drug, PharmaTimes reports. The notice to the government is in a report on the use of anticoagulant therapy. The report acknowledges that there are health and financial benefits to the drug but says some real-world data suggests that it is being used by a different age group of patients and at different doses than the clinical data presented to the PBAC when it approved it last year. That has led the group to say more study may be needed. The agency has invited Boehringer Ingelheim to submit new data.
The company has data it can submit. It recently released results of a longer-term study that showed that over 4.3 years the efficacy and safety of the blockbuster drug did not wane. There also are the FDA findings released in early November. The agency sought to quell growing concerns from physicians about using Pradaxa, a drug that already has hit blockbuster status because it doesn't come with the nasty side effects associated with warfarin. But it also doesn't have an antidote for bleeding like warfarin does, so some doctors have publicly discussed frustrations. The FDA sorted through thousands of records to determine that despite an onslaught of adverse-event reports--and hundreds of deaths--rates of gastrointestinal bleeding and intracranial hemorrhage were no higher in Pradaxa patients than in those using the older drug.
Still, the FDA this week warned doctors against using Pradaxa in patients with mechanical heart valves, pointing out that a study was stopped because they "were more likely to experience strokes, heart attacks and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin."
- read the PharmaTimes story