FDA Approves Sprout's Controversial Libido Drug, with Warnings

Source: xconomy

Aug 19, 2015

The U.S. FDA approved Sprout Pharmaceuticals' highly-discussed Addyi (flibanserin) to treat low sexual desire in women, but the approval comes with a strict monitoring program to guard against safety risks associated with the drug.

According to the FDA, Addyi can cause severely low blood pressure and loss of consciousness. Risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines. Due to the risks, the FDA is requiring that Addyi prescriptions come from certified physicians who must counsel patients, and scripts must be filled by pharmacies trained on the drug’s risks. Flibanserin will also carry a boxed warning detailing the drug’s risks.

Sprout resubmitted the New Drug Application for flibanserin three times amid much controversy before being granted approval. The process garnered attention from major national news outlets as many pointed out the disparity in the number of FDA drugs approved for male sexual dysfunction versus female. 

Read the xconomy article  

Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.

Comments

No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments