Many older adults take anticoagulants to manage a variety of conditions. But new guidance on how to use them has caused some controversy because it changed some wording. It said certain medications should be avoided instead of used with caution, which prompted scrutiny from two employees of a company that markets one of the drugs.
Mar Creixell, PharmD, PhD, and Ante Harxhi, MD, both employees of Janssen Pharmaceuticals, published a letter on Sept. 22 in the Journal of the American Geriatrics Society in response to The American Geriatric Society (AGS) Beers Criteria, which was updated this year. The previous update was in 2019.
The updates shared recommendations on vitamin K antagonists (like warfarin) and direct oral anticoagulants, or DOACs, such as rivaroxaban, apixaban and dabigatran, to treat nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE). In the US, Janssen markets Xarelto, or rivaroxaban.
“We recognize the purpose is to identify medications for which potential harms outweigh the expected benefit in older adults [at or over 65 years old],” the authors wrote.
The Beers panel made the “strong” recommendation that the use of rivaroxaban in these two indications should be changed from the 2019 recommendation of “use with caution” to “avoid” in “favor of safer anticoagulant alternatives.”
The report says the change was made based on a “moderate” quality of evidence from recent observational studies and network meta-analyses. That research found an increased risk of major and gastrointestinal bleeding in older adults taking rivaroxaban compared to other DOACs.
Creixell and Harxhi said the recommendation on rivaroxaban in people over the age of 65 was concerning because telling people to avoid it as opposed to using it with caution seemed “overly severe” based on observational studies and meta analyses. The guidance didn’t share which publications the Beers panel used to justify that change, Creixell and Harxhi said.
“It is generally understood in the field that ‘low-quality evidence’ or even ‘moderate’ evidence should not support a ‘strong’ recommendation,” Creixell and Harxhi wrote.
Creixell and Harxhi also said the wording in “favor of safer anticoagulant alternatives” was misleading, because there’s no randomized controlled trials comparing safety and/or efficacy of DOACs to say which is safer.
Both Janssen employees say the guidance conflicts with prescribing information for the drug, too.
“The risk of deprescribing in patients successfully managed with rivaroxaban based on these guidelines is concerning,” Creixell and Harxhi wrote. “Considering the potential risk of a thrombotic event when stopping and/or transitioning from one anticoagulant to another, patients successfully managed on rivaroxaban should not be forced to transition to another therapy based solely on the recommendations of the Beers criteria.”
Creixell and Harxhi say the guidance gives important safety considerations. Because older adults are at risk for ischemic and bleeding events, doctors need to assess the risk of thrombotic events should be weighed against the risk of bleeding when choosing anticoagulants. The Janssen employees wrote in their letter that it’s better to maintain the previous recommendations than advise people to use it with caution.
