Has the FDA Taken any Action Against Xarelto?

FDA VERSUS XARELTO

The Controversy Begins

Several years ago, Bayer Pharmaceuticals invented an anticoagulant know as Rivaroxaban; although, it would come to be labeled under the name Xarelto. After oral consumption and absorption in the gut, it works by inhibiting the factor Xa. Its primary use includes blood thinning and blood clot prevention. It works up to nearly half of a day, or twelve hours. After its manufacture, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) handles its marketing and distribution.

In the beginning of 2011, Janssen applied for approval to the United States Food and Drug Administration (FDA) in order to market Xarelto. While eventually successful in obtaining approval from the FDA, the agency expressed significant concerns regarding the drug. Specifically, it doubted the veracity of the information Janssen proffered in support of its application. Also, it questioned the low prediction of side effects (for things such as internal bleeding, wound damage, or internal organ damage) from taking Xarelto within Janssen's statistical support. Nevertheless, it granted approval for the drug for the limited confines of deterring embolisms and thrombosis in hip and knee replacement surgeries.

The FDA Gives Demands

In the summer of 2011, the FDA gave conditions for the approval (which eventually came in November of that year) of the marketing and distribution of Xarelto. There were essentially three requirements that Janssen had to abide by, including the following:

1. Create, manufacture, market, and distribute a low-dose alternative (either in a 5, 10, or other size milligram pill).

2. Conduct clinical studies examining possible side effects.

3. Report all bleeding episodes of patients prescribed Xarelto for three years.

The FDA also expressed concerns with the sufficiency of Janssen's evidence supporting its suppositions regarding the claimed benefits of Xarelto as well as the actual efficacy of the drug itself. For instance, it questioned whether there were enough people in the clinical trials to support many of Janssen's major assumptions regarding the benefits of the medicine. Also, the FDA wondered if Xarelto was preferable to- or even necessary with-current alternatives, such as Warfarin. Again, however, it did not preclude the release of the drug into the market.

Janssen Looks to Expand Xarelto

In the middle of 2012, Janssen met with a committee of the FDA to consider several uses beyond its original 2011 application. That committee eventually decided that it could not count on any information offered by the company because of its dubious origins, or at least unsubstantial nature. It voted against an expansion. However, Janssen was successful later in that year of obtaining consent from the FDA for a broader application of Xarelto into the medical market. Yet, with that permission, the FDA also tacked a stern message of alarm regarding the possibility of excessive bleeding after taking the drug. Yet, as before, none of these concerns stopped the agency from blocking Xarelto from flooding into another market.

Janssen's Advertising Missteps

In June of 2013, the FDA wrote to Johnson & Johnson regarding the marketing practices of its affiliate, Janssen Pharmaceuticals. It stated that in two different ares the company had misleadingly advertised its drug, Xarelto. First, Janssen minimized the seriousness and frequency of possible side effects that include, among others, bleeding, blood clots, and wound aggravation. Second, it contradicted its own label by claiming that patients did not have to adhere to any dosage restrictions. For all of these violations, however, the FDA took no other action besides sending these communications.

FDA Takes Action

Finally, in 2014, the FDA responded to the questionable science and assumptions underlying Xarelto by requiring Janssen to include certain warnings with the marketing and distribution of the drug (including one to its "black box"). These include some of the following:

• Its inability to stop bleeding brought about by the consumption of Xarelto.
• The dangerous combination of Xarelto and certain other drugs.
• The damaging relationship between taking Xarelto and undergoing spinal surgery.
• The possibility of liver or kidney damage.
• The insufficiency of statistics underlying many Janssen statements regarding Xarelto.