Black Box Warning

WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE LINZESS is contraindicated in patients less than 2 years of age; in nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )]. WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE See full prescribing information for complete boxed warning. LINZESS is contraindicated in patients less than 2 years of age; in neonatal mice, linaclotide caused deaths due to dehydration. ( 4 , 5.1 , 8.4 )

What this means:A black box warning is the FDA's strongest required safety notice. It signals a serious or life-threatening risk. Patients should review this with their prescriber before starting, continuing, or switching Linzess.

Other warnings & precautions

BLACK BOX WARNING — Pediatric Risk: Linzess is contraindicated in patients 6 years of age and younger. Juvenile mice given linaclotide died from dehydration. Avoid use in patients 6 to 17 years of age. The safety and effectiveness have not been established in this age group.
Severe Diarrhea: Severe diarrhea has been reported. Patients requiring hospitalization for dehydration or electrolyte imbalance have been reported. If severe diarrhea occurs, suspend dosing and rehydrate the patient; reassess benefit-risk before resuming therapy.
Dehydration and Electrolyte Imbalance: Monitor patients at increased risk, including the elderly, patients with cardiac disease, renal impairment, or those taking diuretics for signs of dehydration and electrolyte abnormalities during treatment.
Mechanical Gastrointestinal Obstruction: Linzess is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Using a secretagogue in the presence of obstruction may cause bowel perforation or worsening obstruction.
Hypersensitivity Reactions: Discontinue Linzess and treat appropriately if signs or symptoms of a serious hypersensitivity reaction (anaphylaxis, angioedema) occur, although such reactions are rare given minimal systemic absorption.
Drug Interaction — Electrolyte-Active Medications: Particular caution is warranted when Linzess is used concurrently with medications that can cause hypokalemia or alter fluid balance, including loop diuretics, thiazides, and corticosteroids.
Post-Marketing Safety: Rectal hemorrhage and hematochezia have been reported; evaluate for organic colorectal pathology including colorectal malignancy before initiating therapy in appropriate patients.
Pregnancy Considerations: Animal studies at supratherapeutic doses suggest potential fetal harm. There are no adequate data in pregnant women. Use in pregnancy only if clearly needed and benefit outweighs risk; counsel patients accordingly.
Breastfeeding: It is not known whether linaclotide or its active metabolite is present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need and any potential adverse effects.
Long-Term Use: The safety of Linzess beyond 26 weeks has not been established in controlled trials. Periodically reassess the need for continued therapy and perform appropriate diagnostic evaluation if symptoms change significantly.

Other warnings & precautions

BLACK BOX WARNING — Pediatric Risk: Linzess is contraindicated in patients 6 years of age and younger. Juvenile mice given linaclotide died from dehydration. Avoid use in patients 6 to 17 years of age. The safety and effectiveness have not been established in this age group.

Severe Diarrhea: Severe diarrhea has been reported. Patients requiring hospitalization for dehydration or electrolyte imbalance have been reported. If severe diarrhea occurs, suspend dosing and rehydrate the patient; reassess benefit-risk before resuming therapy.

Dehydration and Electrolyte Imbalance: Monitor patients at increased risk, including the elderly, patients with cardiac disease, renal impairment, or those taking diuretics for signs of dehydration and electrolyte abnormalities during treatment.

Mechanical Gastrointestinal Obstruction: Linzess is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Using a secretagogue in the presence of obstruction may cause bowel perforation or worsening obstruction.

Hypersensitivity Reactions: Discontinue Linzess and treat appropriately if signs or symptoms of a serious hypersensitivity reaction (anaphylaxis, angioedema) occur, although such reactions are rare given minimal systemic absorption.

Drug Interaction — Electrolyte-Active Medications: Particular caution is warranted when Linzess is used concurrently with medications that can cause hypokalemia or alter fluid balance, including loop diuretics, thiazides, and corticosteroids.

Post-Marketing Safety: Rectal hemorrhage and hematochezia have been reported; evaluate for organic colorectal pathology including colorectal malignancy before initiating therapy in appropriate patients.

Pregnancy Considerations: Animal studies at supratherapeutic doses suggest potential fetal harm. There are no adequate data in pregnant women. Use in pregnancy only if clearly needed and benefit outweighs risk; counsel patients accordingly.

Breastfeeding: It is not known whether linaclotide or its active metabolite is present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need and any potential adverse effects.

Long-Term Use: The safety of Linzess beyond 26 weeks has not been established in controlled trials. Periodically reassess the need for continued therapy and perform appropriate diagnostic evaluation if symptoms change significantly.

Linzess Black Box Warning

Black Box Warning

Other warnings & precautions

Linzess Black Box Warning

Black Box Warning

Other warnings & precautions