FDA Issues Warning Letter to Johnson & Johnson

In June of 2013, the FDA's Office of Prescription Drug Promotion (OPDP) issued a cease and desist letter to Johnson & Johnson, the manufacturer of Xarelto®. In its letter, the FDA asserted that certain print advertising for Xarelto® was misleading since it stated that dosage adjustments for Xarelto® were not necessary and that periodic blood tests were not required.

This claim was contrary to the approved prescribing information for Xarelto® which directs physicians to periodically test the renal function of patients who are renally-compromised (through blood testing) and to adjust the dosage for such patients when clinically indicated.

Since Xarelto® is a medication that is eliminated through the kidneys, patients who are renally-impaired may not have the ability to eliminate all of the medication in a safe and timely manner. As kidney function declines, the body's ability to eliminate Xarelto® will likely decline as well. The result is a "stacking" effect where, as a result of declining kidney function, the amount of Xarelto® circulating in the blood increases. Add to that the patients normal daily dosing and the result can be uncontrolled bleeding.

Clearly, prescribing physicians must be adequately warned to conduct periodic blood testing of patients who are renally-compromised and to adjust the dosage for such patients when clinically indicated so that the risk of overmedication and uncontrolled bleeding is minimized.