A report from the US Food and Drug Administration (FDA) published in Pharmacoepidemiology & Drug Safety has confirmed the safety profile and effectiveness of the anticoagulant Xarelto (rivaroxaban) in people with atrial fibrillation (AF), the manufacturer, German chemicals and life sciences group Bayer, said.

The study based on electronic healthcare data within the Mini-Sentinel safety program in the US, reporting data on a large real-world population of over 115,000 people who were prescribed rivaroxaban or warfarin, could potentiall boost the defense’s arguments in ongoing lawsuits brought by patents who say they were harmed by the drug.

To examine the safety of both products, rates of gastrointestinal bleeding, ischemic stroke and intracranial hemorrhage in people with AF were evaluated. Findings from the study, part of the active drug safety surveillance of the FDA,  are said to point to a lower risk of ischemic stroke and intercranial hemorrhage associated with the use of rivaroxaban compared to warfarin, while the risk of gastrointestinal bleeding was lower with warfarin.

Bayer said the FDA’s analysis is consistent with the findings it has seen in both clinical trials and real-world studies.

Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral anticoagulant (NOAC) worldwide. Xarelto is approved for seven indications.

The drug jointly developed by Bayer and Janssen Research & Development, a subsidiary of US healthcare giant Johnson& Johnson (J&J) is approved in more than 130 countries. It is marketed outside the US by Bayer and in the US by Janssen Pharmaceuticals.

According to a filing by J&J quoted by news agencies, at the end of 2017 more than 21,000 liability cases against Xarelto were pending in the US, most of them claiming gastrointestinal bleeding.

Bayer and J&J have won three of the four cases heard so far, losing their first in December, when a jury in Philadelphia, Pennsylvania, ordered the companies to pay $1.8 million in compensatory and $26 million in punitive damages to an Indiana couple. Both drugmakers said they planned to appeal.

While the lawsuits have claimed that Xarelto package information does not disclose its risks, Bayer & J&J have insisted that it does and noted also that the FDA has “repeatedly confirmed” the drug’s safety and efficacy.