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.

OMEGAVEN (NDA-210589)

(FISH OIL TRIGLYCERIDES)

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

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07/24/2025 (SUPPL-5)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Hypersensitivity Reactions

Additions and/or revisions underlined:

Omegaven contains fish oil and egg phospholipids, which may cause hypersensitivity reactions. In postmarketing experience, anaphylaxis has been reported following Omegaven administration [see Adverse Reactions (6.2)].

Omegaven is contraindicated in patients with known hypersensitivity to fish or egg protein or to any of the active or inactive ingredients in Omegaven [see Contraindications (4)]. If a hypersensitivity reaction occurs, stop infusion of Omegaven immediately and initiate appropriate treatment and supportive measures.

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined

The following adverse reactions have been identified during post-approval use of Omegaven. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hematologic system disorders: hemorrhage

Immune system disorders: hypersensitivity reactions, including anaphylaxis [see Contraindications (4), Warnings and Precautions (5.2)]

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

. . .

Hypersensitivity reactions

Inform caregivers that Omegaven may cause hypersensitivity reactions, including anaphylaxis. If Omegaven is infused at home, instruct caregivers to stop the infusion of Omegaven immediately and seek medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as rapid or weak heartbeat, feeling faint, difficulty in breathing or swallowing, vomiting, nausea, headache, sweating, dizziness, hives, rash, itching, flushing, dizziness, fever, or chills [see Warnings and Precautions (5.2)].

. . .

05/17/2023 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants

(Additions and/or revisions underlined)

In the postmarket setting, serious adverse reactions including acute respiratory distress, metabolic acidosis, and death have been reported in neonates and infants after rapid infusion of intravenous lipid emulsions. Hypertriglyceridemia was commonly reported.

Strictly adhere to the recommended total daily dosage; the hourly infusion rate should not exceed 1.5 mL/kg/hour [see Dosage and Administration (2.3)].

Preterm and small for gestational age infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.

Carefully monitor the infant’s ability to eliminate the infused lipids from the circulation (e.g., measure serum triglycerides and/or plasma free fatty acid levels). If signs of poor clearance of lipids from the circulation occur, stop the infusion and initiate a medical evaluation [see Warnings and Precautions (5.4, 5.6) and Overdosage (10)].

5.8 Monitoring/Laboratory Tests

Routine Monitoring

(Additions and/or revisions underlined)

Monitor fluid status closely in patients with pulmonary edema or heart failure.

Throughout treatment, monitor serum triglycerides [see Warnings and Precautions (5.7)], fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count (including platelets), and coagulation parameters.

The lipids contained in Omegaven may interfere with the results of some laboratory tests (e.g., hemoglobin, lactate dehydrogenase, bilirubin, oxygen saturation) if the blood is sampled before the lipids have cleared from the bloodstream. Conduct these tests at least 6 hours after stopping the infusion.

Omegaven contains Vitamin K that may counteract anticoagulant activity [see Drug Interactions (7)].

Essential Fatty Acids

Monitoring patients for signs and symptoms of essential fatty acid deficiency (EFAD) is recommended. Laboratory tests are available to determine serum fatty acids levels. Reference values should be consulted to help determine adequacy of essential fatty acid status. Increasing essential fatty acid intake (enterally or parenterally) is effective in treating and preventing EFAD.

6 Adverse Reactions

(Additions and/or revisions underlined)

The following clinically significant adverse reactions are described elsewhere in the labeling:

Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants [see Warnings and Precautions (5.1)]
Hypersensitivity reactions [see Warnings and Precautions (5.2)]

8 Use in Specific Populations

8.4 Pediatric Use

(Additions and/or revisions underlined)

The effectiveness of Omegaven was established in two open-label clinical trials of

82 pediatric patients, 3 to 42 weeks of age, including preterm neonates with estimated gestational age of greater than 24 weeks at birth. Patients administered Omegaven attained and maintained growth through at least 108 weeks of treatment [see Clinical Studies (14)].

The safety of Omegaven was established in 189 pediatric patients (19 days to 15 years of age). The most common adverse reactions in Omegaven-treated patients were vomiting, agitation, and bradycardia [(see Adverse Reactions (6.1)].

In the postmarketing setting, clinical decompensation with rapid infusion of intravenous lipid emulsion in neonates and infants, sometimes fatal has been reported [see Warnings and Precautions (5.1)].

Preterm neonates and infants who receive treatment with Omegaven may be at risk of aluminum toxicity and other metabolic abnormalities [see Warnings and Precautions (5.7, 5.8)].

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

17 PATIENT COUNSELING INFORMATION

(Extensive changes; please refer to label for complete information)