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Premarin (conjugated estrogens) Vaginal Cream
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2012
Premarin Vaginal Cream therapy should not be used in women with any of the following conditions:
- Known anaphylactic reaction or angioedema to Premarin Vaginal Cream
- Known protein C, protein S or antithrombin deficiency, or other known thrombophilic disorders
WARNINGS AND PRECAUTIONS
Anaphylactic Reaction and Angioedema
- Cases of anaphylaxis, which develop within minutes to hours after taking orally-administered Premarin and require emergency management, have been reported in the postmarketing setting. Skin (hives, pruritus, swollen lips-tongue-face) and either respiratory tract (respiratory compromise) or gastrointestinal tract (abdominal pain, vomiting) involvement has been noted.
- Angioedema involving the tongue, larynx, face, and feet requiring medical intervention has occurred postmarketing in patients taking orally-administered Premarin. If angioedema involves the tongue, glottis, or larynx, airway obstruction may occur. Patients who develop an anaphylactic reaction with or without angioedema after treatment with oral Premarin should not receive oral Premarin again.
- Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema.
Clinical Trials Experience (TABLE)
Number (%) of Patients Reporting Treatment Emergent Adverse Reactions ≥ 1 Percent Only:
- Body As A Whole: Abdominal Pain…Headache…Moniliasis…Pain…Pelvic Pain
- Cardiovascular System: Migraine…Vasodilation
- Musculoskeletal System: Muscle Cramp
- Nervous System: Dizziness
- Skin and Appendages: Acne…Erythema…Pruritus
- Urogenital System: Breast Enlargement…Breast Pain…Dysuria…Leukorrhea…Metrorrhagia…Urinary Frequency…Urinary Tract Infection…Urinary Urgency…Vaginal Hemorrhage…Vaginal Moniliasis…Vaginitis…Vulvovaginal Disorder
Who should not use Premarin Vaginal Cream?
Do not start using Premarin Vaginal Cream if you:
- Have been diagnosed with a bleeding disorder