The FDA Center for Drug Evaluation and Research (CDER) has issued a warning on the use of medicinal products containing drospirenone; ethinyl estradiol (drospirenone; ethinyl estradiol) in women who currently have or have had breast cancer in the past.
Section “Contraindications”
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Drospirenone; ethinylestradiol is contraindicated in women who are known to have or develop the following conditions:
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– Current or past breast cancer, which may be hormone-sensitive [see section “Warnings and precautions”, subsection “Malignant neoplasms”]
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Section “Warnings and precautions”
Subsection “Malignant neoplasms”
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Breast cancer
Drospirenone; ethinylestradiol is contraindicated in women who currently have or have had breast cancer in the past, because breast cancer may be hormone-sensitive (see section “Contraindications”).
Epidemiological studies have not found a consistent association between the use of combined oral contraceptives (COCs) and the risk of breast cancer. The studies do not show an association between ever (current or past) use of COCs and the risk of breast cancer. However, some studies report a small increase in the risk of breast cancer among those who are currently or recently using (<6 months since last use) and those who have used COCs before (see the section "Adverse reactions," subsection "Post-marketing data").
“Adverse reactions” section
Subsection “Post-registration data”
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Five studies comparing the risk of breast cancer between ever users (current or past) of COCs and never users of COCs reported no association between COC use and the risk of breast cancer, with effect estimates from 0,90 to 1,12 (Figure 3).
Three studies compared the risk of breast cancer between current or recent COC users (<6 months since last use) and those who had never used them (Fig. 3). One of these studies reported no association between the risk of breast cancer and COC use. Two other studies found an increased relative risk of 1,19-1,33 with current or recent use. Both of these studies found an increased risk of breast cancer with long-term use, with the relative risk ranging from 1,03 for less than one year of COC use to approximately 1,4 for more than 8-10 years of COC use.
Figure 3: Relative studies of the risk of breast cancer with the use of combined oral contraceptives
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The original text is available at the link https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1183
