UPDATE: Eliquis tied to fewer serious adverse events

Share this article:

Warfarin replacements Xarelto, Pradaxa and Eliquis were not significantly different from the older drug in terms of overall safety reports, healthcare informatics company AdverseEvents said, based on an analysis of post-approval data. However, patients taking Eliquis, the oral anticoagulant being co-marketed by Pfizer and Bristol-Myers Squibb, reported a relatively lower number of serious adverse events like hospitalization or death.

Among Eliquis patients reporting side effects, 21% said they had been hospitalized, while among those on warfarin, 50% cited hospitalizations. By comparison, 43% of patients taking J&J's Xarelto and 39% of those on Boehringer Ingelheim's Pradaxa flagged events of a serious nature.

In response to the report, J&J's Janssen unit issued the following statement: "The cross-treatment comparison in this report lacks scientific validity for a number of reasons. Apixaban was approved recently for one clinical use. In just over one year, it has been prescribed to far fewer patients and may not yet have an established pattern in reported adverse events. It is not valid to compare one medicine with a single use to other medicines that have several clinical uses, different durations of therapy and far more patients using the treatments.”

Janssen also pointed out that, to date, 5.4 million prescriptions have been written for Xarelto in the US across its six indications since 2011, and about 435,000 prescriptions since 2012 across its single indication. In addition, it pointed out, the FDA standard for comparing the safety of treatments requires substantial evidence, such as two adequate and well-controlled studies.

Share this article:
You must be a registered member of MMM to post a comment.

Next Article in Business Briefs

Email Newsletters

MM&M Future Leaders

Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.