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.

EFFIENT (NDA-022307)

(PRASUGREL HYDROCHLORIDE)

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

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12/22/2020 (SUPPL-18)

Approved Drug Label (PDF)

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

Patient Information

(Additions and/or revisions underlined)

Before you take Effient, tell your doctor about all of your medical conditions. . .

• Serious allergic reactions. Serious allergic reactions can happen with Effient, or if you have had a serious allergic

reaction to medicines called thienopyridines, for example clopidogrel (Plavix*) or ticlopidine hydrochloride.

03/28/2019 (SUPPL-16)

Approved Drug Label (PDF)

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

MEDICATION GUIDE

Newly added section; please refer to label for complete information.

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Administration

Advise patients not to break Effient tablets.
Remind patients not to discontinue Effient without first discussing it with the physician who prescribed Effient.
Inform patients to keep Effient in the container in which it comes, and keep the container closed tightly with the gray cylinder (desiccant) inside.
Bleeding
Inform patients that they:
will bruise and bleed more easily …
Thrombotic Thrombocytopenic Purpura
Instruct patients to get prompt medical attention if they experience symptoms of TTP that cannot otherwise be explained.
Hypersensitivity
Inform patients that they may have hypersensitivity reactions and to seek immediate medical attention if any signs and symptoms of a hypersensitivity reaction occur. Patients …

03/09/2018 (SUPPL-15)

Approved Drug Label (PDF)

7 Drug Interactions

Newly added subsection:

7.3 Opioids

As with other oral P2Y12 inhibitors, co-administration of opioid agonists delay and reduce the absorption of prasugrel’s active metabolite presumably because of slowed gastric emptying.

Consider the use of a parenteral anti-platelet agent in acute coronary syndrome patients requiring co- administration of morphine or other opioid agonists.

07/12/2016 (SUPPL-14)

Approved Drug Label (PDF)

6 Adverse Reactions

The following serious adverse reactions are also discussed elsewhere in the labeling:

Hypersensitivity Including Angioedema (addition)

8 Use in Specific Populations

Lactation (PLLR Conversion)

Risk Summary

There is no information regarding the presence of prasugrel in human milk, the effects on the breastfed infant, or the effects on milk production. Metabolites of prasugrel were found in rat milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Effient and any potential adverse effects on the breastfed child from Effient or from the underlying maternal condition.

Data

Animal Data

Following a 5-mg/kg oral dose of [14C]-prasugrel to lactating rats, metabolites of prasugrel were detected in the maternal milk and blood.

Pediatric Use

In a randomized, placebo-controlled trial, the primary objective of reducing the rate of vaso-occlusive crisis (painful crisis or acute chest syndrome) in pediatric patients, aged 2 to less than 18 years, with sickle cell anemia was not met (addition of sentence).

Pregnancy (PLLR Conversion)

Risk Summary

There are no data with Effient use in pregnant women to inform a drug-associated risk. No structural malformations were observed in animal reproductive and developmental toxicology studies when rats and rabbits were administered prasugrel during organogenesis at doses of up to 30 times the recommended therapeutic exposures in humans. Due to the mechanism of action of Effient, and the associated identified risk of bleeding, consider the benefits and risks of Effient and possible risks to the fetus when prescribing Effient to a pregnant woman.
The background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.

Data

Animal Data

In embryo fetal developmental toxicology studies, pregnant rats and rabbits received prasugrel at maternally toxic oral doses equivalent to more than 40 times the human exposure. A slight decrease in fetal body weight was observed; but, there were no structural malformations in either species. In prenatal and postnatal rat studies, maternal treatment with prasugrel had no effect on the behavioral or reproductive development of the offspring at doses greater than 150 times the human exposure.