Sales of blood thinner Pradaxa flourish despite safety issues

pradaxa Sales of blood thinner Pradaxa flourish despite safety issuesDrug maker Boehringer Ingelheim enjoyed some gains during the first six months of 2012, but the next six months may be a bit rocky. “The economic headwind from the sovereign debt crisis in southern Europe and the continued weak economic growth in the USA make the business environment increasingly difficult for the pharmaceutical industry,” Andreas Barner, chairman of the board, said in a statement.

Barner added that the economic and financial strains have hampered the launches of two of its newer medications – the blood thinner Pradaxa and the diabetes drug Tradjenta. Pradaxa alone brought in $678 million in sales in the first six months of 2012. Sales of the blood thinner for the calendar year 2011 topped $1 billion.

Pradaxa was highly anticipated from the moment it hit the market. In the United States, it was approved in October 2010 to prevent strokes in patients with a heart rhythm abnormality called atrial fibrillation. It became the first anticoagulant in 50 years to go head-to-head with warfarin for stroke prevention in atrial fibrillation patients.

It was an attractive alternative because patients on warfarin must be regularly monitored to prevent bleeding problems. However, unlike warfarin, there are no reversal agents available to stop the anti-clotting effects of Pradaxa, leaving patients at greater risk for death or serious injuries in the event of a major bleed. This has made many people question the safety of Pradaxa and whether it should remain on the market.

According to Food and Drug Administration records, 3,781 adverse events and 542 deaths were associated with Pradaxa use in 2011 alone, surpassing all other monitored drugs. Now, more and more doctors are carefully considering whether it is safe to prescribe Pradaxa to patients.

Meanwhile, Boehringer Ingelheim continues to reap the profits of its blockbuster drug but is cautious about the future. “Sustaining the positive business development in the first half of 2012 over the next six months will be challenging,” Finance chief Hubertus von Baumbach said in a statement.

Source: Medical Marketing & Media