FDAnews Drug Daily Bulletin

Is Pradaxa an example of flawed approval processes? (World of DTC Marketing Blog)
“Pradaxa has become a blockbuster drug in its two years on the market, bringing in more than $1 billion in sales,” according to The New York Times. “But Pradaxa has been linked to more than 500 deaths in the United States, and a chorus of complaints.” The drug is an example, some critics say, of what can happen when a medication that performs well in tightly controlled trials is released into the messy world of real-life medicine.