Estring (estradiol vaginal ring) August 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

Summary View

Sections Modified

ADVERSE REACTIONS

• Postmarketing Experience
  • A few cases of toxic shock syndrome (TSS) have been reported...
  • A few cases of ring adherence to the vaginal wall, making ring removal difficult, have been reported...
  • A few cases of bowel obstruction and vaginal ring use have been reported...

PATIENT PACKAGE INSERT

• Who should not use Estring?
  • Currently have or have had liver problems.
• What are the possible side effects of Estring?
  • Initial Paragraph
• What can I do to lower my chances of getting a serious side effect with Estring?