Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

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.

ARISTADA (NDA-207533)

(ARIPIPRAZOLE LAUROXIL)

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

Download Data

Expand all

08/27/2020 (SUPPL-17)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

(Additions and/or revisions underlined)

The following adverse reactions have been identified during post-approval use of oral aripiprazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure: occurrences of allergic reaction (anaphylactic reaction, angioedema, laryngospasm, pruritus/urticaria, or oropharyngeal spasm), pathological gambling, hiccups, blood glucose fluctuation, oculogyric crisis, and drug reaction with eosinophilia and systemic symptoms (DRESS).

11/30/2018 (SUPPL-13)

Approved Drug Label (PDF)

5 Warnings and Precautions

Newly added subsection:

5.3 Potential for Dosing and Medication Errors

Medication errors, including substitution and dispensing errors, between ARISTADA and ARISTADA INITIO could occur. ARISTADA INITIO is for single administration in contrast to ARISTADA which is administered monthly, every 6 weeks, or every 8 weeks. Do not substitute ARISTADA INITIO for ARISTADA because of differing pharmacokinetic profiles.

6 Adverse Reactions

6.1 Clinical Studies Experience

Additions and/or revisions underlined:

ARISTADA

Patient Exposure

ARISTADA has been evaluated for safety in 1180 adult patients …

8 Use in Specific Populations

8.5 Geriatric Use

Newly added information:

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ARISTADA is not approved for the treatment of patients with dementia- related psychosis.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Pregnancy Registry

Advise patients that there …

06/05/2017 (SUPPL-4)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Studies Experience

(Additions and/or revisions are underlined)

ARISTADA

Patient Exposure

ARISTADA has been evaluated for safety in 1019 adult patients in clinical trials in schizophrenia.

8 Use in Specific Populations

8.1 Pregnancy

(Additions and/or revisions are underlined)

Risk Summary

…No teratogenicity was observed in animal reproductive studies withintramuscular administration of aripiprazole lauroxil to rats and rabbits during organogenesis at doses up to 5 and 15 times, respectively, the maximum recommended human dose (MRHD) of 1064 mg based on body surface area (mg/m2)….

Data

Animal Data for Aripiprazole Lauroxil

Aripiprazole lauroxil did not cause adverse developmental or maternal effects in rats or rabbits when administered intramuscularly during the period of organogenesis at doses of 18, 49, or 144 mg/animal in pregnant rats which are approximately 0.6 to 5 times the maximum recommended human dose (MRHD) of 1064 mg on mg/m2 basis, and at doses of 241, 723, and 2893 mg/animal in pregnant rabbits which are approximately 1 to 15 times the MRHD on mg/m2 basis.

02/23/2017 (SUPPL-6)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.8. Falls

(Newly added subsection)

Antipsychotics including ARISTADA may cause somnolence, postural hypotension, or motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for those patients on long-term antipsychotic therapy.

6 Adverse Reactions

(Additions and/or revisions are underlined)

The following are discussed in more details in other sections of the labeling:

Falls

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

17. PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Falls

Advise patients and their caregivers of the possibility that they may experience somnolence, postural hypotension, or motor and sensory instability, which may lead to the risk of falls, particularly in patients with diseases, conditions, or medications that could exacerbate these effects.

08/18/2016 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

Pathological Gambling and Other Compulsive Behaviors (additional section)

Post-marketing case reports suggest that patients can experience intense urges, particularly for gambling, and the inability to control these urges while taking aripiprazole. Other compulsive urges, reported less frequently include: sexual urges, shopping, eating or binge eating, and other impulsive or compulsive behaviors. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or intense gambling urges, compulsive sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with aripiprazole. It should be noted that impulse-control symptoms can be associated with the underlying disorder. In some cases, although not all, urges were reported to have stopped when the dose was reduced or the medication was discontinued. Compulsive behaviors may result in harm for the patient and others if not recognized. Consider dose reduction or stopping the medication if a patient develops such urges.

6 Adverse Reactions

The following adverse reactions are discussed in more detail in other sections of the labeling:

Pathological Gambling and Other Compulsive Behaviors (addition)

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

MG - What are the possible side effects of ARISTADA?

ARISTADA may cause serious side effects, including:

Gambling urges and other uncontrollable (compulsive) behaviors. Some people taking aripiprazole products have had strong urges to gamble. Other strong urges include increased sex drive, spending money (compulsive shopping), binge eating or eating that you cannot control. If you or your family members notice that you are having strong urges, talk to your healthcare provider. These behaviors may go away if your dose of ARISTADA is lowered or stopped.

PCI - Pathological Gambling and Other Compulsive Behaviors

Advise patients and their caregivers of the possibility that they may experience compulsive urges to shop, intense urges to gamble, compulsive sexual urges, binge eating and/or other compulsive urges and the inability to control these urges while taking aripiprazole. In some cases, but not all, the urges were reported to have stopped when the dose was reduced or stopped.