Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

TRIPHASIL-21 (NDA-019192)

(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-49)

Approved Drug Label (PDF)

4 Contraindications

Additions underlined

Triphasil-21 is contraindicated in females who are known to have or develop the following conditions:

…

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

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5 Warnings and Precautions

WARNINGS

Additions underlined

…

3. MALIGNANT NEOPLASMS

Breast Cancer

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

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 also among current users with longer duration of COC use. (see Adverse Reactions).

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6 Adverse Reactions

Additions underlined

Postmarketing 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 1).

Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). 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 1: Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives

Please refer to label to view Figure1.

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

PATIENT INFORMATION

Brief Summary Patient Package Insert

Additions underlined

…

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. In addition, some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives.

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DETAILED PATIENT LABELING

Additions underlined

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WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES

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Breast cancer or a history of breast cancer

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RISK OF TAKING ORAL CONTRACEPTIVES

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5. Risk of cancer

It is not known if hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use.

If you have breast cancer now, or have had it in the past, do not use hormonal birth control because some breast cancers are sensitive to hormones.

Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives.

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However, this finding may be related to factors other than the use of oral contraceptives.

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05/08/2019 (SUPPL-48)

Approved Drug Label (PDF)

5 Warnings and Precautions

Precautions

(addition underlined)

…

6.HEREDITARY ANGIOEDEMA

In females with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.

...

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

PATIENT INFORMATION

(addition underlined)

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OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES

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Hereditary angioedema.

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08/09/2017 (SUPPL-47)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions are underlined)

Women who are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (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 Triphasil-21 prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. Triphasil-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 HCV Combination Therapy – Liver Enzyme Elevation

Do not co-administer Triphasil-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)

Brief Summary Patient Package Insert

…

You should not take the pill if you take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.

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This product’s label may have been updated. For current full prescribing information, please visit www.pfizer.com.

DETAILED PATIENT LABELING

WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES

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