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.

FACTIVE (NDA-021158)

(GEMIFLOXACIN MESYLATE)

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

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05/03/2019 (SUPPL-26)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.8 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 FACTIVE for use only when there are no alternative antibacterial treatments available.

6 Adverse Reactions

(additions underlined)

…

Risk of Aortic Aneurysm and Dissection

…

Blood Glucose Disturbances

…

8 Use in Specific Populations

8.5 Geriatric 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 FACTIVE?

FACTIVE may cause serious side effects, including:

…

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)

…

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

…

12/13/2018 (SUPPL-24)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

FACTIVE is contraindicated in patients with a history of hypersensitivity to gemifloxacin, other fluoroquinolone antibacterial agents, or any of the product components.

8 Use in Specific Populations

8.1 Pregnancy

8.2 Lactation

PLLR conversion; extensive changes. Please refer to label for complete information.

8.4 Pediatric Use

8.5 Geriatric Use

8.7 Hepatic Impairment

Extensive changes; please refer to label for complete information.

8.6 Gender

8.8 Renal Impairment

Newly created subsections; please refer to label for complete information.

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

PATIENT COUNSELING INFORMATION

Extensive changes; please refer to label for complete information.

Other

PLR conversion; extensive changes. Please refer to label for complete information.

10/18/2018 (SUPPL-25)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS

(Additions and/or revisions are underlined)

Central Nervous System Effects:

Psychiatric Adverse Reactions: Fluoroquinolones, including FACTIVE, have been associated with an increased risk of psychiatric adverse reactions, including toxic psychosis, hallucinations or paranoia; depression, suicidal thoughts or acts; anxiety, agitation, or restlessness; confusion, delirium, disorientation, or disturbances in attention; insomnia; memory impairment. If these reactions occur in patients receiving FACTIVE, discontinue FACTIVE immediately and institute appropriate measures.

Central Nervous System Adverse Reactions: Fluoroquinolones, including FACTIVE, have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (pseudotumor cerebri), lightheadedness; and tremors. As with other fluoroquinolones, FACTIVE should be used with caution in patients with CNS diseases such as epilepsy or patients predisposed to convulsions. If these reactions occur in patients receiving FACTIVE, discontinue FACTIVE immediately and institute appropriate measures.

Blood Glucose Disturbances: Fluoroquinolones have been associated with disturbances of blood glucose, including symptomatic hyperglycemia, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. Severe cases of hypoglycemia resulting in coma or death have been reported from other Fluoroquinolones. If a hypoglycemic reaction occurs in a patient being treated with FACTIVE, discontinue FACTIVE and initiate appropriate therapy immediately.

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

MEDICATION GUIDE FACTIVE® [FAC-tiv](gemifloxacin) 320mg Tablets

What are the possible side effects of FACTIVE?

(Additions and/or revisions are underlined)

Changes in blood sugar
People who take fluoroquinolone medicines with oral anti-diabetes medicines or with insulin can get low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). Follow your healthcare provider’s instructions for how often to check your blood sugar. If you have diabetes and you get low blood sugar while taking FACTIVE, stop taking FACTIVE and call your healthcare provider right away. Your antibiotic medicine may need to be changed.

07/26/2016 (SUPPL-23)

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

Because fluoroquinolones, including FACTIVE, have been associated with serious adverse reactions, reserve FACTIVE 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 FACTIVE, 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 FACTIVE. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.
Discontinue FACTIVE immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including FACTIVE, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.

Peripheral Neuropathy (new sentences added)

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

Tendinitis and Tendon Rupture replaces Tendinopathy

Fluoroquinolones, including FACTIVE, 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 FACTIVE, 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 FACTIVE immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Avoid fluoroquinolones, including FACTIVE, 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 - How should I take FACTIVE?

Do not skip any doses of FACTIVE, or stop taking it, even if you begin to feel better, until you finish your prescribed treatment unless:

you have nerve problems. See “What is the most important information I should know about FACTIVE?”
you have central nervous system problems. See “What is the most important information I should know about FACTIVE?”

MG - What is FACTIVE?

FACTIVE 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.

FACTIVE 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 pneumoniae.

Before you take FACTIVE, tell your healthcare provider if you:

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

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

Tendon rupture or swelling of the tendon (tendinitis).

Stop taking FACTIVE 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 FACTIVE. (addition)

PCI - Serious Adverse Reactions

Advise patients to stop taking FACTIVE 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 FACTIVE 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 FACTIVE and may occur together in the same patient. Inform patients to stop taking FACTIVE immediately if they experience an adverse reaction and to call their healthcare provider. (addition)
Tendinitis and tendon rupture replaces Tendon Disorders