EMA’s safety committee recommends a 4-week limit for use of high-strength estradiol creams
The European Medicines Agency (EMA) pharmacovigilance risk assessment committee (PRAC) has recommended limiting the use of high-strength estradiol vaginal creams (containing 100 micrograms/g or 0.01%) to a single treatment period of up to 4 weeks.
The PRAC review concluded that in postmenopausal women who had used these creams, the levels of estradiol in the blood were higher than normal postmenopausal levels and could result in similar side effects to those seen with systemic (oral or transdermal) hormone replacement therapy (HRT).
The side effects of HRT include venous thromboembolism, stroke, endometrial cancer, and breast cancer.
In the absence of safety data for long-term use of high-strength estradiol creams, the PRAC recommended that these creams should only be used for a single treatment period of a maximum of 4 weeks. This formulation should not be used in patients already on hormone replacement therapy. Other vaginal estrogen formulations are available and may be preferred.
Treatment of recurrent UTI in postmenopausal women includes use of vaginally applied estrogen therapy to restore the normal vaginal flora and reduce the risk of vaginal colonisation by Escherichia coli. Vaginally applied estrogen therapy demonstrated a decreased incidence and longer time to recurrence of UTI in hypo-estrogenic women. However, its use is inferior to continuous antibiotic suppression in prevention of UTIs.
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Can be clinically categorized into uncomplicated/complicated, acute, or recurrent.
Escherichia coli is the most common organism in uncomplicated infections.
Costovertebral angle tenderness together with fever suggests pyelonephritis.
Diagnosed using urine dipstick, microscopic urinalysis (bacteria, white blood cell, red blood cell), and urine culture.
Antibiotic selection should be guided by local bacterial susceptibilities and guidelines, or based on known urine culture and sensitivity.
A urinary tract infection (UTI) is an infection of the kidneys, bladder, or urethra. Infectious cystitis is the most common type of UTI, which is caused by a bacterial infection of the bladder. Pyelonephritis is an infection of the kidney that often occurs via bacterial ascent, and urethritis is an infection causing an inflammation of the urethra.
History and exam
Female Pelvic Medicine and Reconstructive Surgery
Section of Urology and Renal Transplantation
Virginia Mason Medical Center
UJL declares that she has no competing interests.
Dr Una J. Lee would like to gratefully acknowledge Dr Elliot Blau for his contribution to this monograph, and Dr Bhavin N. Patel and Dr Howard B. Goldman, previous contributors to this topic.
Cleveland Clinic Foundation
PS declares that she has no competing interests.
Associate Residency Director
Texas Tech University Health Sciences Center
TJB declares that he has no competing interests.
Professor of Primary Care Research
Community Clinical Sciences Division
University of Southampton
PL declares that he has no competing interests.
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