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.

NOROXIN (NDA-019384)

(NORFLOXACIN)

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

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07/26/2016 (SUPPL-67)

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

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

Peripheral Neuropathy (new sentences added)

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

Tendinitis and Tendon Rupture replaces Tendinopathy

Fluoroquinolones, including NOROXIN, 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 NOROXIN, 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 NOROXIN immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Avoid fluoroquinolones, including NOROXIN, 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 NOROXIN, tell your healthcare provider if you:

Additions underlined:

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

MG - How should I take NOROXIN? (additions underlined)

Do not skip any doses of NOROXIN, 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 NOROXIN?”
you have central nervous system problems. See “What is the most important information I should know about NOROXIN?”

MG - What is NOROXIN?

NOROXIN 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.
NOROXIN 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 NOROXIN?

Tendon rupture or swelling of the tendon (tendinitis).

Stop taking NOROXIN 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 NOROXIN. (addition)

PCI - Serious Adverse Reactions

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