Ever since the blood-thinning drug Pradaxa won FDA approval back in 2010, it has been the subject of significant legal fireworks. Disgruntled patients have alleged that Pradaxa’s lack of a “reversal agent” make it a potentially very dangerous drug. On other hand, the blood thinner market is extremely lucrative – worth up to $10 billion or more, according to some estimates. So even though Pradaxa has been associated with problems like pulmonary embolism and other heart issues, it remains a blockbuster product for Boehringer Ingelheim.
Pradaxa may have some new challengers on the block – specifically, Janssen Pharmaceuticals’ new drug, Xarelto. The U.S. Food & Drug Administration recently granted Xarelto a priority review status, which means that within just a half a year, an FDA review of the product could be finished. (The standard time period for such a review is 10 to 12 months.)
Janssen believes that Xarelto could help treat deep vein thrombosis and pulmonary embolism.
Unfortunately, some researchers and consumer advocates believe Xarelto may have similar side effects to Pradaxa. Like Pradaxa, it is non-reversible. Data from the FDA’s Adverse Event Reporting System peg Xarelto as the primary suspect in almost a thousand different adverse events – the primary one being pulmonary embolism, a profound and potentially fatal condition.
On the one hand, it’s understandable that drug manufacturers want to push to find a replacement for Warfarin, the most commonly prescribed generic blood-thinner. Warfarin is far from perfect. On the other hand, it’s disturbing to see that the FDA would rush through a drug that’s been closely associated with problems like pulmonary embolism and that has the same “no U-turn” issue that Pradaxa has.
It’s great that drug manufacturers are able to produce and disburse life saving drugs to people in dire need. That said, when the scientific review process is not conducted appropriately – and people are not warned of risks or effectively watched for side effects – victims and their families often suffer grievously. If you or someone you care about has gotten ill due to the side effects of Xarelto or Pradaxa, connect with the team here at Carey, Danis & Lowe for a free a consultation, and explore your potential rights to obtain a recovery.
