FDA Has Problems With Print Ad For J&J Stroke Drug Xarelto, Letter Says

The Food and Drug Administration told Johnson & Johnson that a direct-to-consumer print advertisement for Xarelto (rivaroxaban) tablets is false or misleading because it minimizes the drug’s risks and makes a misleading claim, according to an “untitled” letter posted June 19 on FDA’s website.

The print advertisement appeared in the January/February issue of WebMD magazine, the agency said.

Xarelto is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The prescribing information contains boxed warnings regarding increased risk of stroke after discontinuation in patients with nonvalvular atrial fibrillation and the risk of spinal/epidural ...