Post-Marketing Surveillance of Rivaroxaban Finds the Drug "Inherently Safe"

Research on the post-marketing surveillance of rivaroxaban found that the drug was as safe as determined from the results of the anticoagulant’s randomized controlled trial.

A poster presented at the European Society of Cardiology's annual congress in London looked at almost 40,000 people taking rivaroxaban after it was approved by the FDA to determine how often they bled and what the consequences were, explained W. Frank Peacock IV, MD, from the Baylor College of Medicine, in a video interview with MD Magazine.

“When you have a randomized controlled trial, you have a very refined population of people with a certain age and a certain risk factor profile that is well described,” he said. “When you roll out to the public and all doctors anywhere can use it, you’re not always certain they’re going to apply it right and that risk-benefit analysis may change.”

He added that sometimes when a drug is rolled out to the public, there are “strange little things” that happen. In the case of this study, that did not occur.

“We wanted to make sure that the results that we had in real life look like the results that we had when we studied it in a randomized controlled trial,” Dr Peacock said.

The study found that of the nearly 40,000 people in the study, 970 had a bleed and most of them had a gastrointestinal bleed. In addition, 35 people died, mostly from intracranial hemorrhages. Dr Peacock added that the bleed rate was about 2.89 for 100 patient years and the risk of dying was 0.1.

“This is all statistically consistent with what we saw in the trials and it goes to show you that these drugs are inherently safe,” he said.