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.

DEPO-PROVERA (NDA-020246)

(MEDROXYPROGESTERONE ACETATE)

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

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12/12/2025 (SUPPL-74)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Meningioma

Newly added subsection:

Cases of meningiomas have been reported following repeated administration of medroxyprogesterone acetate, primarily with long term use. Monitor patients on Depo-Provera CI for signs and symptoms of meningioma. Discontinue Depo-Provera CI if a meningioma is diagnosed.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Counsel patients with a history of meningioma about the possible risk of worsening meningioma [see Warnings and Precautions (5.4)].

…

PATIENT INFORMATION

Additions and/or revisions underlined:

…

What should I tell my healthcare professional before taking Depo-Provera CI?

Before taking Depo-Provera CI, tell your healthcare professional if you have:

…

have or have ever had a type of usually benign brain tumor called a meningioma

….

What are the possible side effects of Depo-Provera CI? Depo-Provera CI can cause serious side effects, including:

…

possible increased risk for growth of a meningioma (a usually benign brain tumor), primarily when the product is used for a long time.

…

07/11/2024 (SUPPL-68)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion

Additions and revisions underlined:

Risk Summary

There is no use for contraception in pregnancy; therefore, Depo-Provera CI should be discontinued during pregnancy.

Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to progestins before conception or during early pregnancy.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

8.2 Lactation

PLLR conversion

Newly added subsection:

Risk Summary

Although medroxyprogesterone acetate is detectable in the milk of mothers receiving Depo-Provera CI, milk composition, quality, and amount do not appear to be adversely affected. Effects on milk production and lactation initiation/duration remain unclear when administered before 6 weeks after delivery, therefore, in mothers who exclusively breastfeed, initiate Depo-Provera CI during or after the sixth post-partum week [see Dosage and Administration (2.1)].

No adverse effects in breastfed infants would be expected with maternal use of progestins. Neonates and infants exposed to medroxyprogesterone acetate from breast milk have been studied and no adverse effects have been noted.

The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for Depo-Provera CI and any potential adverse effects on the breastfed child from Depo-Provera CI or from the underlying maternal condition.

8.3 Females and Males of Reproductive Potential

PLLR conversion

Newly added subsection:

Depo-Provera CI is indicated for the prevention of pregnancy and would therefore be expected to impair female fertility until cessation of treatment. Women may experience a delay in return to ovulation and fertility (conception) following discontinuation of Depo-Provera CI [see Warnings and Precautions (5.14)].

12/04/2020 (SUPPL-60)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Loss of Bone Mineral Density

(Additions and/or revisions underlined)

Use of Depo-Provera CI reduces serum estrogen levels and is associated with significant loss of bone mineral density (BMD). This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. It is unknown if use of Depo-Provera CI by younger women will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.

A study to assess the reversibility of loss of BMD in adolescents was conducted with Depo-Provera CI. After discontinuing Depo-Provera CI in these adolescents, mean BMD loss at the total hip and femoral neck did not fully recover by 5 years (60 months) post-treatment in the sub-group of adolescents who were treated for more than 2 years [see Clinical Studies (14.3)]. Similarly, in adults, there was only partial recovery of mean BMD at the total hip, femoral neck, and lumbar spine towards baseline by 2 years post-treatment [see Clinical Studies (14.2)].

The use of Depo-Provera CI is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. BMD should be evaluated when a woman needs to continue to use Depo-Provera CI long-term. In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity.

12/04/2020 (SUPPL-62)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Loss of Bone Mineral Density

(Additions and/or revisions underlined)

12/16/2016 (SUPPL-58)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.6 Injection Site Reactions

(new subsection added)

Injection site reactions have been reported with use of Depo-Provera CI.

Persistent injection site reactions may occur after administration of Depo-Provera CI due to inadvertent subcutaneous administration or release of the drug into the subcutaneous space while removing the needle.

6 Adverse Reactions

6.2 Post-marketing Experience

( addition of injection site reactions to the “body as a whole” section of Table 3, please refer to label)