Australia's drug regulator says Pradaxa safety advice will not change
- In the last five years, there have been 280 reported Pradaxa-related deaths and 1,400 adverse events.
- Australia’s drug regulator, the Therapeutic Goods Administration (TGA), contends that the label does not need updating, as there were only seven Pradaxa-related deaths between January and April of 2014---and there were also three warfarin-related deaths.
- Boehringer Ingelheim (BI) has already settled numerous lawsuits in response to claims from patients who suffered from various adverse events. The expected total payout is $650 million.
Pradaxa is a $1.6 billion drug that was heralded as a new and better anticoagulant option that warfarin — the standard-bearer of anticoagulation for the last half-century. However, though Pradaxa does not require the monitoring and constant titration associated with warfarin, there have been hundreds of adverse events, including internal bleeding and heart attacks, since Pradaxa was launched in 2012.
Nonetheless, TGA suggests that the number of Pradaxa-related deaths are decreasing as physicians become more familiar with using it. The bottom line: Pradaxa’s label will not change in Australia.
- pharmafile.com Pradaxa ‘safe’ says Australian regulator