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.

OVRETTE (NDA-017031)

(NORGESTREL)

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

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08/15/2017 (SUPPL-35)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions are underlined)

Opill Tablets is contraindicated for use by women who are known to have the following conditions:

Known or suspected carcinoma of the breast, or other progestin-sensitive cancer, now or in the past

5 Warnings and Precautions

PRECAUTIONS

(Additions and/or revisions are underlined)

3. Gastrointestinal

Diarrhea and/or vomiting within 4 hours after taking a pill may reduce hormone absorption. Women should use of a nonhormonal back-up method of birth control (such as a condom or spermicide) during the next 48 hours.

6. Carbohydrate and Lipid Effects

Some Opill Tablets users may experience slight changes in glucose tolerance with increases in plasma insulin, but women with diabetes mellitus who use progestin-only oral contraceptives do not generally experience changes in their insulin requirements.

The effect of progestin-only oral contraceptives on carbohydrate and lipid metabolism is generally not clinically significant.

WARNINGS

(Additions and/or revisions are underlined)

2. Delayed Follicular Atresia/Ovarian Cysts

Often they are asymptomatic; in some cases they are associated with mild abdominal pain, and rarely they may twist or rupture, requiring surgical intervention.

3. Bleeding Pattern Alterations

Irregular menstrual patterns are common among women using Opill Tablets. Undiagnosed abnormal uterine bleeding should be evaluated before Opill is prescribed. In the 8 U.S. clinical trials of Opill Tablets, there were a total of 2,575 enrolled subjects, and approximately half of them experienced some menstrual changes. This was defined in the clinical studies as vaginal bleeding which, in the judgment of the subject, did not have the characteristics of her pre-treatment menstrual periods in duration, amount or appearance. Subjects experienced unscheduled (breakthrough) bleeding (48.6%) and spotting (47.3%) on Opill Tablets. Amenorrhea occurred in 6.1% of subjects in their first cycle and 28.7% of all subjects during the studies. A total of 379 participants (17.4%) discontinued treatment due to side effects; 67.6% of all discontinuations were due to bleeding patterns. Overall, 6.4% of participants discontinued treatment due to breakthrough bleeding and 2.7% due to amenorrhea (n=2,173 subjects who completed at least one cycle).

If uterine bleeding together with the clinical history is suggestive of infection, malignancy, pregnancy, or other conditions, rule out these conditions. If amenorrhea occurs, consider the possibility of pregnancy.

4. Hepatic Neoplasia/Liver Disease

Discontinue Opill Tablet use if jaundice or acute disturbances of liver function develop. Do not resume use until markers of liver function return to normal and Opill Tablet causation has been excluded.

6 Adverse Reactions

(Additions and/or revisions are underlined)

The following adverse reactions were reported in greater than or equal to 5% of subjects in the Opill Tablet clinical studies:

Dysmenorrhea
Backache

7 Drug Interactions

(Additions and/or revisions are underlined)

The effectiveness of progestin-only pills is reduced by hepatic enzyme-inducing drugs such as phenytoin, carbamazepine, barbiturates, rifampin, efavirenz, bosentan and herbal preparations containing St. John’s Wort (hypericum perforatum).

During concomitant use of Opill and substances that may affect its efficacy, it is recommended that a nonhormonal back-up method of contraception (such as condom) be used in addition to the regular intake of Opill Tablets. Use of a nonhormonal back-up method is recommeded for 28 days after discontinuation of substances that have led to induction of hepatic microsomal enzymes.

Effectiveness of progestin-containing hormonal contraceptives and emergency contraceptive ulipristal acetate may be decreased if progestin-containing hormonal contraceptives are used within five days after ulipristal acetate dosing.

If a woman wishes to use Opill Tablets after using ulipristal acetate, she should do so no sooner than 5 days after the intake of ulipristal acetate and she should use a reliable barrier method for subsequent acts of intercourse until her next menstrual period.

8 Use in Specific Populations

(Additions and/or revisions are underlined)

Pregnancy

Opill Tablets are contraindicated for use in pregnant women because there is no need for pregnancy prevention in a woman who is already pregnant. Published studies report no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins in pregnant women.

Discontinue Opill Tablets if pregnancy is confirmed.

Nursing Mothers

Small amounts of progestin pass into the breast milk, resulting in steroid levels in infant plasma. No adverse effects have been reported on breastfeeding performance or infant health. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Opill Tablets and any potential adverse effects on the breastfed infant from Opill Tablets or from the underlying maternal condition.

Pediatric Use

Safety and efficacy of Opill Tablets have been established in women of reproductive age, including adolescents as young as 15 years of age, and almost 30% of subjects in the clinical trials who were under 20 years of age. Use of this product before menarche is not indicated.

Geriatric Use

Opill Tablets has not been studied in postmenopausal women and is not indicated in this population.

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

INFORMATION FOR THE PATIENT

(Additions and/or revisions are underlined)

Advise the patient to read the FDA-approved patient labeling (Patient Information).

She should use a nonhormonal back-up method of contraception (such as condoms or spermicides) for the next 48 hours whenever Opill Tablets are taken 3 or more hours late, or if she has vomiting or diarrhea within 4 hours after taking the pill.
Use of Opill Tablets may be associated with changes in their normal menstrual bleeding pattern. However, women who miss two periods (or have missed a single period but have missed doses of Opill) or suspect they may be pregnant should take a pregnancy test.
She should inform her healthcare provider if she develops repeated vaginal postcoital bleeding, prolonged episodes of bleeding, amenorrhea or development of severe abdominal pain.
Opill Tablets do not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).

Patient Information

(Extensive changes; please refer to label)

08/15/2017 (SUPPL-36)

Approved Drug Label (PDF)

Other

The label has been updated with the new proprietary name, Opill®.