Drug Safety-related Labeling Changes (SrLC)

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NORDETTE-21 (NDA-018668)

(ETHINYL ESTRADIOL; LEVONORGESTREL)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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04/29/2022 (SUPPL-42)

Approved Drug Label (PDF)

4 Contraindications

Additions underlined

  • Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive.

5 Warnings and Precautions

WARNINGS

Additions underlined

11.Malignant Neoplasms

Breast Cancer

NORDETTE-21 is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive [see Contraindications (4)].

Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk. Studies do not show an association between ever (current or past) use of COCs and risk of breast cancer. However, some studies report a small increase in the risk of breast cancer among current or recent users (<6 months since last use) and current users with longer duration of COC use (see ADVERSE REACTIONS, Postmarketing Experience).

6 Adverse Reactions

Additions underlined

Post Marketing Experience

Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 2).

Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). One of these studies reported no association between breast cancer risk and COC use. The other two 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 current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use.

Figure 2: Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives

Please refer to label to view Figure 2.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT INFORMATION

Additions underlined

Do birth control pills cause cancer?

There may be slight increases in the risk of breast cancer among current users of hormonal birth control pills with longer duration of use of 8 years or more.

05/07/2021 (SUPPL-41)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions underlined)

NORDETTE-21 is contraindicated in females who are known to have the following conditions:

  • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:

    • Smoke, if over age 35 [see BOXED WARNING and WARNINGS (1)].

    • Have current or history of deep vein thrombosis or pulmonary embolism [see WARNINGS (1)].

    • Have cerebrovascular disease [see WARNINGS (1)].

    • Have coronary artery disease [see WARNINGS (1)].

    • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS (1)].

    • Have inherited or acquired hypercoagulopathies [see WARNINGS (1)].

    • Have uncontrolled hypertension or hypertension with vascular disease [see WARNINGS (1)].

    • Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or

      vascular disease or other end-organ damage, or diabetes mellitus of >20 years duration [see WARNINGS (7)].

    • Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches [see WARNINGS (8)].

  • Current or history of breast cancer or other estrogen- or progestin-sensitive cancer.

  • Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis [see WARNINGS (2)].

  • Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see WARNINGS (5)].

  • Undiagnosed abnormal uterine bleeding [see WARNINGS (9)].

5 Warnings and Precautions

(Extensive changes; please refer to label)

6 Adverse Reactions

(Extensive changes; please refer to label)

08/09/2017 (SUPPL-40)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions are underlined)

Combination oral contraceptives should not be used in women with any of the following conditions:

Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations.

5 Warnings and Precautions

WARNINGS

(Additions and/or revisions are underlined)

5.           Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment

During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications such as COCs. Discontinue Nordette-21 prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. Nordette-21 can be restarted approximately 2 weeks following completion of treatment with the combination drug regimen.

7 Drug Interactions

(Additions and/or revisions are underlined)

Concomitant Use with Hepatitis C Virus (HCV) Combination Therapy – Liver Enzyme Elevation

Do not co-administer Nordette-21 with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

Patient Information

(Additions and/or revisions are underlined)

DETAILED PATIENT LABELING

WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES

Or, if you have any of the following:

  • Hepatitis C and are taking any drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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