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.

PLAN B (NDA-021045)

(LEVONORGESTREL)

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

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04/24/2018 (SUPPL-17)

Approved Drug Label (PDF)

5 Warnings and Precautions

Warnings

(Additions and/or revisions are underlined)

Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel.

09/28/2017 (SUPPL-16)

Approved Drug Label (PDF)

7 Drug Interactions

(Additions and/or revisions are underlined)

…Some drugs or herbal products that may decrease the effectiveness of progestin-only pills include:

barbiturates (including primidone)

… Concomitant administration of efavirenz has been found to reduce plasma levels of levonorgestrel (AUC) by around 50%, which may reduce the effectiveness of Plan B.

8 Use in Specific Populations

8.4 Pediatric Use

(Additions and/or revisions are underlined)

…Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older…

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

Patient Package Insert

(Additions and/or revisions are underlined)

What is Plan B?

It is a backup method of preventing pregnancy and should not be used as regular birth control.

When should I use Plan B?

The sooner you take emergency contraception, the better it works. You should use Plan B® within 72 hours (3 days) after you have had unprotected sex.

When not to use Plan B?

Plan B should not be used:

as a regular birth control method, because it’s not as effective as regular birth control.

…

When should I talk to a doctor or pharmacist?

Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of Plan B and increase your chance of becoming pregnant. Your doctor may prescribe another form of emergency contraception that may not be affected by these medications.

How does Plan B work?

Plan B is two tablets with levonorgestrel, a hormone that has been used in many birth control pills for several decades…

How can I get the best results from Plan B?

You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex…

How effective is Plan B?

If Plan B is taken as directed, it can significantly decrease the chance that you will get pregnant…

How will I know Plan B worked?

You will know Plan B has been effective when you get your next period, which should come at the expected time, or within a week of the expected time…

Will I experience any side effects?

…If your period is more than a week late, you may be pregnant.
if you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical attention.
if you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose.

Other information

If you are sexually active, you should see a healthcare provider for routine checkups. Your healthcare provider will talk to you about and, if necessary, test you for sexually transmitted diseases, teach you about effective methods of routine birth control, and answer any other questions you may have.