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.

ZMAX (NDA-050797)

(AZITHROMYCIN)

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

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11/22/2021 (SUPPL-26)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Cardiovascular Death

Newly added information:

Some observational studies have shown an approximately two-fold increased shortterm potential risk of acute cardiovascular death in adults exposed to azithromycin relative to other antibacterial drugs, including amoxicillin. The five-day cardiovascular mortality observed in these studies ranged from 20 to 400 per million azithromycin treatment courses. This potential risk was noted to be greater during the first five days of azithromycin use and does not appear to be limited to those patients with preexisting cardiovascular diseases. The data in these observational studies are insufficient to establish or exclude a causal relationship between acute cardiovascular death and azithromycin use. Consider balancing this potential risk with treatment benefits when prescribing ZITHROMAX.

6 Adverse Reactions

Newly added information:

The following clinically significant adverse reactions are described elsewhere in

labeling:

• Hypersensitivity [see Warnings and Precautions (5.1)]

• Hepatotoxicity [see Warnings and Precautions (5.2)]

• Infantile Hypertrophic Pyloric Stenosis (IHPS) [see Warnings and Precautions (5.3)]

• QT Prolongation [see Warnings and Precautions (5.4)]

• Cardiovascular Death [see Warnings and Precautions (5.5)]

• Clostridioides difficile-Associated Diarrhea (CDAD) [see Warnings and Precautions

(5.6)]

• Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.7)]

6.2 Postmarketing Experience

Additions and/or revisions underlined:

Cardiovascular: Arrhythmias including ventricular tachycardia and hypotension. There

have been reports of QT prolongation, and torsades de pointes, and cardiovascular

death.

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

Patient Information

Additions and/or revisions underlined:

What are the possible side effects of ZITHROMAX?

Serious heart rhythm changes that can be life-threatening, including heart

stopping (cardiac arrest), QT prolongation, torsades de pointes, feeling that your

heart is pounding or racing (palpitations), chest discomfort, or irregular

heartbeat.

Tell your healthcare provider right away if you or your child feel a fast or irregular

heartbeat, get dizzy or faint.

04/24/2019 (SUPPL-25)

Approved Drug Label (PDF)

7 Drug Interactions

7.3 Potential Drug-Drug Interaction with Macrolides

Addition of colchicine following digoxin throughout subsection.

8 Use in Specific Populations

8.1 Pregnancy

8.2 Lactation

PLLR conversion; please refer to label for complete information.

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

PATIENT COUNSELING INFORMATION

Addition of the following statement:

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

PATIENT INFORMATION

Tell your healthcare provider about all the medicines you take

Addition of the following:

Zmax and other medicines may affect each other causing side effects. Zmax may affect the way other medicines work, and other medicines may affect how Zmax works.

Especially tell your healthcare provider if you take:

nelfinavir
a blood thinner (warfarin)
digoxin
colchicine
phenytoin
an antacid that contains aluminum or magnesium

03/30/2017 (SUPPL-24)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Allergic and Skin Reactions

Additions and/or revisions underlined:

Serious allergic reactions, including angioedema, anaphylaxis, Acute Generalized Exanthematous Pustulosis (AGEP), Stevens Johnson syndrome, and toxic epidermal necrolysis have been reported in patients on azithromycin therapy using other formulations ...

6 Adverse Reactions

6.2 Postmarketing Experience with Other Azithromycin Products

Additions and/or revisions underlined:

Skin/appendages: Pruritus, rash, photosensitivity, serious skin reactions including erythema multiforme, AGEP, Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS ...

02/09/2017 (SUPPL-21)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Infantile Hypertrophic Pyloric Stenosis (IHPS)

(new subsection added)

Following the use of azithromycin in neonates (treatment up to 42 days of life), IHPS has been

reported. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs.

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

PATIENT COUNSELING INFORMATION

(addition underlined)

General Patient Counseling

…

Direct parents or caregivers to contact their physician if vomiting and irritability with feeding occurs in the infant.

…

Patient Information

(addition underlined)

Contact your healthcare provider immediately if you are giving Zmax to a young child (less than 6 weeks of age) and he or she vomits or becomes irritable when fed.