Premarin Associated With Risk of Malignant Neoplasms

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" Use of conjugated estrogen in women with intact uteri

is associated with an increased risk of endometrial

cancer, the greatest risk occurring with prolonged use

(15- to 24-fold increased risk for 5-10 years of use

or more) and persisting for at least 8 to 15 years

after discontinuation " .

 

 

 

http://www.medscape.com/viewarticle/483415

 

Conjugated Estrogen Alone (Premarin) or With

Medroxyprogesterone (Prempro, Premphase) Associated

With Risk of Malignant Neoplasms

 

On April 20, the FDA approved extensive revisions to

the safety labeling for conjugated estrogen tablets

and vaginal cream (Premarin) and conjugated

estrogen/medroxyprogesterone acetate tablets (Prempro,

Premphase), advising of increased health risks

associated with their use. The products are made by

Wyeth Pharmaceuticals, Inc.

 

The FDA warned that estrogen with or without progestin

should not be used for the prevention of

cardiovascular disease.

 

Use of conjugated estrogen in women with intact uteri

is associated with an increased risk of endometrial

cancer, the greatest risk occurring with prolonged use

(15- to 24-fold increased risk for 5-10 years of use

or more) and persisting for at least 8 to 15 years

after discontinuation.

 

Use of conjugated estrogen is also associated with an

increased risk of breast cancer. Results of the

Million Women Study in Europe showed an increased risk

of mortality due to breast cancer among current users

of estrogen alone or with progestin compared with

therapy-naive patients.

 

Results of the Women's Health Initiative (WHI) study

showed increased risks of myocardial infarction,

stroke, invasive breast cancer, pulmonary emboli, and

deep vein thrombosis in postmenopausal women aged 50

to 79 years during five years of treatment with

conjugated estrogens (0.625 mg) combined with

medroxyprogesterone acetate (2.5 mg), compared with

placebo.

 

The WHI Memory Study showed an increased risk of

probable dementia in postmenopausal women aged 65

years and older treated with combined conjugated

estrogen and medroxyprogesterone acetate over four

years.

 

The FDA notes that although other combinations and

doses were not studied in the WHI clinical trials, the

risks should be assumed to be similar. Estrogen with

or without progestin should be prescribed at the

lowest effective dose and for the shortest duration

consistent with treatment goals.

 

The FDA recommends close clinical monitoring of women

taking these products, including diagnostic measures

such as endometrial sampling to rule out malignancies

in all cases of undiagnosed persistent or recurring

abnormal vaginal bleeding.

 

Conjugated estrogen vaginal cream is indicated in the

treatment of atrophic vaginitis and lichen sclerosus

et atrophicus of the vulva (also known as kraurosis vulvae).