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.

FERRLECIT (NDA-020955)

(SODIUM FERRIC GLUCONATE COMPLEX)

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

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03/16/2022 (SUPPL-20)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

The following additional adverse reactions have been identified with the use of Ferrlecit from postmarketing spontaneous reports:

Cardiovascular System: shock, fetal bradycardia, injection site superficial thrombophlebitis, phlebitis, acute myocardial ischemia with or without myocardial infarction with in-stent thrombosis in the context of hypersensitivity reaction.

Gastrointestinal System: dysgeusia.

Immune System: anaphylactic-type reactions.

Nervous System: loss of consciousness, generalized convulsion, hypoesthesia. Skin and Appendages: skin discoloration, pallor.

…

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Prior to Ferrlecit administration:

Question patients regarding any prior history of reactions to parenteral iron products.
Advise patients of the risks associated with Ferrlecit.

Advise patients to report adverse reactions associated with the use of Ferrlecit, including hypersensitivity, allergic reactions, chest pain, dizziness, lightheadedness, swelling, and breathing problems [see Warnings and Precautions (5.1, 5.2) and Adverse Reactions (6.1, 6.2)].

…

12/02/2020 (SUPPL-19)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Risk of Serious Adverse Reactions in Infants Due to Benzyl Alcohol Preservative

(Additions and/or revisions underlined)

Ferrlecit is not approved for use in neonates or infants. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low-birth-weight infants treated with benzyl alcohol-–preserved drugs, including Ferrlecit. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. (Ferrlecit contains 9 mg of benzyl alcohol per mL) [see Use in Specific Populations (8.4)].

8 Use in Specific Populations

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

Pregnancy

Advise pregnant women about the risk of hypersensitivity reactions which may have serious consequences for the fetus. Advise patients who may become pregnant to inform their healthcare provider of a known or suspected pregnancy (contains benzyl alcohol) [see Use in Specific Populations (8.1)].

Lactation

Advise patients that treatment with FERRLECIT is not recommended for use while breastfeeding [see Use in Specific Populations (8.2)].

8.1 Pregnancy

(Pregnancy and Lactation Labeling Rule (PLLR) conversion; extensive revisions – please refer to label)

8.2 Lactation

(Pregnancy and Lactation Labeling Rule (PLLR) conversion; additions and/or revisions underlined)

Risk Summary

Ferrlecit contains benzyl alcohol. Because benzyl alcohol is rapidly metabolized by a lactating woman, benzyl alcohol exposure in the breastfed infant is unlikely. However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see Warnings and Precautions (5.4) and Use in Specific Populations (8.4)]. Consider alternative iron replacement therapies without benzyl alcohol for use during lactation.

There are no available data on the presence of Ferrlecit in human or animal milk, the effects on milk production, or the effects on the breastfed child.

03/31/2020 (SUPPL-17)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions underlined)

Ferrlecit is contraindicated in patients with known hypersensitivity to sodium ferric gluconate or any of its components. Reactions have included anaphylaxis.

5 Warnings and Precautions

5.4 Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative

(Revised subheading; additions and/or revisions underlined)

Ferrlecit is not approved for use in neonates or infants. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth infants treated with benzyl alcohol-preserved drugs, including Ferrlecit. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. (Ferrlecit contains 9 mg of benzyl alcohol per mL).

6 Adverse Reactions

6.2 Postmarketing Experience

(Additions and/or revisions underlined)

The following additional adverse reactions have been identified with the use of Ferrlecit from postmarketing spontaneous reports: anaphylactic-type reactions, shock, loss of consciousness, generalized convulsion, fetal bradycardia due to severe maternal hypotension or shock, superficial thrombophlebitis at injection site, skin discoloration, pallor, phlebitis, dysgeusia, and hypoesthesia.

8 Use in Specific Populations

8.1 Pregnancy

(Additions and/or revisions underlined)

Pregnancy Category B

There are no adequate and well-controlled studies with Ferrlecit in pregnant women. Reproduction studies have been performed in mice at doses up to 100 mg/kg/day (300 mg/m2/day) and in rats at up to 20 mg/kg/day (120 mg/m2/day). The doses in mice and rats are 4 and 1.5 times the human dose of 125 mg/day (77 mg/m2/day) on a body surface area basis and have revealed no evidence of harm to the fetus due to Ferrlecit. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Ferrlecit contains benzyl alcohol as a preservative. There are no known adverse outcomes associated with fetal exposure to the preservative benzyl alcohol through maternal drug administration; however, the preservative benzyl alcohol can cause serious adverse events and death when administered intravenously to neonates and infants.

Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur with Ferrlecit which may have serious consequences on the fetus, such as fetal bradycardia, especially during the second and third trimester.

8.4 Pediatric Use

(Additions and/or revisions underlined)

The safety and effectiveness of Ferrlecit have been established in pediatric patients 6 to 15 years of age. Safety and effectiveness in pediatric patients younger than 6 years of age have not been established.

Benzyl Alcohol Toxicity and Pediatrics

Ferrlecit is not approved for use in neonates or infants. Serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and low birth weight infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative. In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L).

Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Benzyl alcohol contained in Ferrlecit may cause serious and anaphylactoid reactions in infants and children up to 3 years old. The administration of medications containing benzyl alcohol to newborns or premature neonates has been associated with a fatal “Gasping Syndrome” (symptoms include a striking onset of gasping syndrome, hypotension, bradycardia, and cardio-vascular collapse). Preterm, low-birth weight infants may be more likely to develop these reactions because they could be less able to metabolize benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known (Ferrlecit contains 9 mg of benzyl alcohol per mL).