Label Changes for:

NuvaRing (etonogestrel/ethinyl estradiol vaginal ring)

October 2014

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

October 2014

MEDICATION GUIDE

“What should I do if my NuvaRing comes out of my vagina?”

  • added...Reinsert the ring as soon as you remember...do not reinsert the NuvaRing that has been out of your vagina...Use another birth control method, such as male condoms with spermicide, until the new NuvaRing has been used for 7 days in a row.

 

June 2014

ADVERSE REACTIONS

Postmarketing Experience
  • Reproductive system and breast disorders: galactorrhea 

 

October 2013

WARNINGS AND PRECAUTIONS

Thromboembolic Disorders and Other Vascular Problems
  • Stop NuvaRing use if an arterial thrombotic or venous thromboembolic event (VTE) occurs. Stop NuvaRing use if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately. [See Adverse Reactions (6).]
  • If feasible, stop NuvaRing at least four weeks before and through two weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism, and during and following prolonged immobilization.

 

Hide
(web3)