Pradaxa was originally met with high praise. Shortly after its approval, three major cardiovascular health organizations added it to their care guidelines simultaneously. Many convenience benefits made Pradaxa, the first blood-thinning drug approved since 1954, a clear winner over the effective but troublesome warfarin, which, incidentally, is also used as a rat poison.
Unfortunately, the Pradaxa honeymoon was not to last. In recent months, the European Medicines Agency (EMA) alerted the medical community that it had received reports linked of 256 deaths linked to the drug since its approval. As a result, the EMA urged doctors to prescribe the drug with caution. Of particular concern were the elderly and those who have kidney problems, who may have a hard time eliminating the drug from their system.
The FDA has not yet issued a safety communication about Pradaxa, although it says it is reviewing reports of serious or fatal bleeding events. However, the FDA says it still believes the drug’s benefits outweigh its risks. The FDA also downplayed the reported bleeding events as being due in part to the newness of the drug, which is often known to increase adverse events reporting.
If you have been hurt or lost a loved one, you may be able to persuade the FDA to take stronger action in the case of this drug. Please contact a local personal injury lawyer today to learn more about your rights.
