As this blog and other media sources have reported recently, the rash of lawsuits against Pradaxa may finally be having an affect, not only on the drug’s manufacturer, the German company Boehringer Ingelheim, but also on the entire market for blood thinning drugs.
Last Friday, Johnson & Johnson went back to the U.S. Food & Drug Administration with extra data to try to prove that it’s new anti blood-thinning drug Xarelto is a legitimately safe drug. J&J hopes to compete with the “classic standard” warfarin (a.k.a. Coumadin), which has run afoul of both patients and doctors because of its disturbing side effects and because getting the dosage right is inherently expensive, risky, and time consuming.
Coumadin’s side effects and other issues (e.g. the expensive tests that must be conducted regularly on patients) created a major opening in the blood thinner market, which Boehringer Ingelheim was all too happy to fill with its own drug, Pradaxa. But as anecdote and studies have revealed, Pradaxa is potentially a very flawed and dangerous drug in its own right.
Johnson & Johnson’s alternative – Xarelto – also known as Rivaroxaban – also potentially has problems. It’s currently approved for some highly specific uses – for patients who need a blood thinner after hip or knee replacement surgery or patients at risk for stroke, who also present with atrial fibrillation.
Johnson & Johnson would obviously like to make a play for a larger share of the market. J&J gave the FDA data from a new study, the Atlas study, which examined over 15,000 patients. It seems to suggest that Xarelto, combined with an Aspirin and another drug, led to a reduction in heart attacks, deaths, and strokes. Of course, without examining the data in depth, it is difficult to comment – but Xarelto has a more checkered record than you might realize, if you just looked at the J&J publicity materials about the Atlas study.
We all want drugs like Coumadin, Xarelto, Pradaxa, etc to work and to save lives with minimal side effects. No one expects drug manufacturers to be perfect or to create products that have zero side effects and only upsides. However, when drug makers and even Federal watchdogs fail to warn consumers effectively about potential side effects – e.g. unstoppable bleeding – then consumers and their family members deserve vigorous assistance. The team at the law offices of Carey, Danis & Lowe can help you understand what you might be able to do, if you or someone you care about suffered side effects while taking Xarelto or Pradaxa.
