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.

MOXIFLOXACIN HYDROCHLORIDE (NDA-205572)

(MOXIFLOXACIN HYDROCHLORIDE)

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

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03/27/2020 (SUPPL-7)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion, please refer to label for complete information).

8.2 Lactation

(PLLR conversion)

Risk Summary

It is not known if moxifloxacin is present in human milk. Based on animal studies in rats, moxifloxacin may be excreted in human milk (see Data). When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Moxifloxacin Injection and any potential adverse effects on the breastfed child from Moxifloxacin Injection or from the underlying maternal condition.

Data

In lactating rats given a single oral dose of 4.59 mg/kg moxifloxacin (approximately 9 times less than the recommended human dose based on body surface area) 8 days postpartum, there was very low excretion of substance-related radioactivity into the milk, amounting to approximately 0.03% of the dose.

8.4 Pediatric Use

(extension additions and revisions, please refer to label for complete information)

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

MEDICATION GUIDE

(section updated, please refer to label for complete information)

05/03/2019 (SUPPL-6)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.9 Risk of Aortic Aneurysm and Dissection

(new subsection added)

Epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients. The cause for the increased risk has not been identified. In patients with a known aortic aneurysm or patients who are at greater risk for aortic aneurysms, reserve Moxifloxacin Injection for use only when there are no alternative antibacterial treatments available.

8 Use in Specific Populations

8.5Geriatric Use

(additions underlined)

…

Epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients.

…

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

MEDICATION GUIDE

(additions underlined)

…

What are the possible side effects of moxifloxacin injection?

…

Aortic aneurysm and dissection. Tell your healthcare provider if you have ever been told that you have an aortic aneurysm, a swelling of the large artery that carries blood from the heart to the body. Get emergency medical help right away if you have sudden chest, stomach, or back pain.

…

PATIENT COUNSELING INFORMATION

(additions underlined)

…

Inform patients of the following serious adverse reactions that have been associated with moxifloxacin or other fluoroquinolone use:

…

Aortic aneurysm and dissection: Inform patients to seek emergency medical care if they experience sudden chest, stomach, or back pain.

…

10/18/2018 (SUPPL-4)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Central Nervous System Effects

(Additions and/or revisions are underlined)

Psychiatric Adverse Reactions

Fluoroquinolones, including moxifloxacin, have been associated with an increased risk of psychiatric adverse reactions, including: toxic psychosis, hallucinations, or paranoia; depression or suicidal thoughts or acts; anxiety, agitation, or nervousness; confusion, delirium, disorientation, or disturbances in attention; insomnia or nightmares; and memory impairment. These adverse reactions may occur following the first dose. If these reactions occur in patients receiving moxifloxacin, discontinue moxifloxacin immediately and institute appropriate measures.

Central Nervous System Adverse Reactions

Fluoroquinolones, including moxifloxacin, have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (including pseudotumor cerebri), dizziness, and tremors. As with all fluoroquinolones, use moxifloxacin with caution in patients with known or suspected CNS disorders (for example, severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold. These adverse reactions may occur following the first dose. If these reactions occur in patients receiving moxifloxacin, discontinue moxifloxacin immediately and institute appropriate measures.

5.12 Blood Glucose Disturbances

(Additions and/or revisions are underlined)

As with all fluoroquinolones, disturbances in blood glucose, including both hypoglycemia and hyperglycemia have been reported with moxifloxacin. In moxifloxacin-treated patients, dysglycemia occurred predominantly in elderly diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (for example, sulfonylurea) or with insulin. Severe cases of hypoglycemia resulting in coma or death have been reported. In diabetic patients, careful monitoring of blood glucose is recommended. If a hypoglycemic reaction occurs, discontinue moxifloxacin and initiate appropriate therapy immediately.

07/26/2016 (SUPPL-2)

Approved Drug Label (PDF)

Boxed Warning

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

Fluoroquinolones, including MOXIFLOXACIN®, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including:

Tendinitis and tendon rupture
Peripheral neuropathy
Central nervous system effects

Discontinue MOXIFLOXACIN immediately and avoid the use of fluoroquinolones, including MOXIFLOXACIN, in patients who experience any of these serious adverse reactions. Fluoroquinolones, including MOXIFLOXACIN, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid MOXIFLOXACIN in patients with known history of myasthenia gravis.

Because fluoroquinolones, including MOXIFLOXACIN, have been associated with serious adverse reactions, reserve MOXIFLOXACIN for use in patients who have no alternative treatment options for the following indications:

Acute exacerbation of chronic bronchitis
Acute uncomplicated cystitis
Acute sinusitis

5 Warnings and Precautions

Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects (addition)

Fluoroquinolones, including MOXIFLOXACIN, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting MOXIFLOXACIN. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.
Discontinue MOXIFLOXACIN immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including MOXIFLOXACIN, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.

Peripheral Neuropathy (new sentences added)

Fluoroquinolones, including MOXIFLOXACIN, have been associated with an increased risk of peripheral neuropathy. Cases of sensory…
…minimize the development of an irreversible condition…Avoid fluoroquinolones, including MOXIFLOXACIN, in patients who have previously experienced peripheral neuropathy.

Tendinitis and Tendon Rupture replaces Tendinopathy

Fluoroquinolones, including MOXIFLOXACIN, have been associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur, within hours or days of starting MOXIFLOXACIN, or as long as several months after completion of fluoroquinolone therapy... Tendinitis and tendon rupture can occur bilaterally.
The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Discontinue MOXIFLOXACIN immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Avoid fluoroquinolones, including MOXIFLOXACIN, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture.

6 Adverse Reactions

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:

Disabling and Potentially Irreversible Serious Adverse Reactions (addition)
Tendinitis and Tendon Rupture (replaces Tendon Effects)

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

MG - Before you take MOXIFLOXACIN, tell your healthcare provider if you:

have a disease that causes muscle weakness (myasthenia gravis); MOXIFLOXACIN should not be used in patients who have a known history of myasthenia gravis.
have nerve problems; MOXIFLOXACIN should not be used in patients who have a history of a nerve problem called peripheral neuropathy

MG - What is MOXIFLOXACIN?

MOXIFLOXACIN should not be used in patients with acute exacerbation of chronic bronchitis, acute uncomplicated cystitis, and sinus infections, if there are other treatment options available.
MOXIFLOXACIN should not be used as the first choice of antibacterial medicine to treat lower respiratory tract infections cause by a certain type of bacterial called Streptococcus pneumonia.

MG - What is the most important information I should know about MOXIFLOXACIN?

Tendon rupture or swelling of the tendon (tendinitis).

Stop taking MOXIFLOXACIN immediately and get medical help right away…
Worsening of myasthenia gravis (a problem that causes muscle weakness). Tell your healthcare provider if you have a history of myasthenia gravis before you start taking MOXIFLOXACIN. (addition)

PCI - Serious Adverse Reactions

Advise patients to stop taking MOXIFLOXACIN if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug. Inform patients of the following serious adverse reactions that have been associated with MOXIFLOXACIN or other fluoroquinolone use:

Disabling and potentially irreversible serious adverse reactions that may occur together: Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and central nervous system effects, have been associated with use of MOXIFLOXACIN and may occur together in the same patient. Inform patients to stop taking MOXIFLOXACIN immediately if they experience an adverse reaction and to call their healthcare provider. (addition)
Tendinitis and tendon rupture replaces Tendon Disorders