The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for phosphodiesterase 5 (PDE-5) inhibitors regarding a new contraindication with guanylate cyclase stimulators, such as riociguat.

The labeling update pertains to the increased risk of hypotension with concomitant use of PDE-5 inhibitors and guanylate cyclase stimulators (eg, riociguat). Affected products include: vardenafil HCl, sildenafil, tadalafil, vardenafil HCl, and avanafil. These PDE-5 inhibitors are indicated for the treatment of erectile dysfunction. The inhibition of PDE-5 enhances erectile function by increasing the amount of cGMP. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in erection.

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The sNDA provides a new Contraindication to the labeling, as well as revisions to other sections including Highlights, Dosage and Administration, Patient Counseling Information, and Patient Information.


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For more information call (888) 463-6332 or visit FDA.gov.