Can a pregnant woman take Linzess (linaclotide) for constipation?

Can a Pregnant Woman Take Linzess for Constipation?

No, pregnant women should not take Linzess (linaclotide) for constipation—safer, well-established alternatives including dietary fiber, polyethylene glycol, and lactulose should be used instead. 1, 2, 3

Why Linzess Should Be Avoided in Pregnancy

Limited Safety Data

• The FDA drug label explicitly states that "available data on LINZESS use in pregnant women are not sufficient to inform any drug-associated risk for major birth defects and miscarriage." 3
• While linaclotide has negligible systemic absorption and is not expected to result in fetal exposure, the lack of adequate human pregnancy data makes it inappropriate as a first-line or even second-line option. 3
• Animal studies showed severe maternal toxicity and fetal effects in mice at high doses, though rats and rabbits showed no adverse effects. 3

Not Included in Pregnancy Guidelines

• The 2024 AGA Clinical Practice Update on pregnancy-related gastrointestinal disease does not include linaclotide among recommended treatments for constipation in pregnancy. 1
• Current pregnancy guidelines specifically recommend dietary fiber, lactulose, and polyethylene glycol-based laxatives as safe treatment options. 1

Recommended Treatment Algorithm for Constipation in Pregnancy

Step 1: Dietary and Lifestyle Modifications

• Increase dietary fiber to approximately 30 g/day through fruits (prunes, raisins, apples, pears), vegetables (broccoli, kale, spinach, sweet potatoes), whole grains, and legumes. 2
• Aim for 3-4 servings of fruits and 3-4 servings of vegetables daily. 2
• Ensure adequate fluid intake, particularly water, to soften stools. 2
• Allow sufficient time for bowel movements and use relaxation techniques. 2

Step 2: Bulk-Forming Agents (If Dietary Changes Insufficient)

• Psyllium husk or methylcellulose are safe during pregnancy due to minimal systemic absorption. 2
• These agents improve stool viscosity and transit time while increasing bulk. 2
• Caution: Excessive fiber can cause maternal bloating. 2

Step 3: Osmotic Laxatives (If Bulk-Forming Agents Fail)

• Polyethylene glycol (PEG) can be safely administered during pregnancy and is the preferred osmotic laxative. 1, 2
• Lactulose is also safe and is the only osmotic agent specifically studied in pregnancy, though it may cause more bloating than PEG. 1, 2
• Both agents are well-established with extensive safety data in pregnant populations. 1, 2

Step 4: Short-Term Rescue Therapy Only

• Stimulant laxatives (bisacodyl, senna) should generally be avoided as safety data are conflicting and they should only be used for short-term relief if absolutely necessary. 2

Clinical Pitfalls to Avoid

Common Mistakes

• Do not prescribe newer secretagogues (linaclotide, plecanatide, lubiprostone) during pregnancy due to insufficient safety data, even though they are effective for IBS-C and chronic constipation in non-pregnant populations. 1, 3
• Do not withhold treatment thinking constipation is a minor issue—it affects 20-40% of pregnant women and significantly impacts quality of life. 2
• Do not skip evaluation for secondary causes: assess for hypothyroidism, hypercalcemia, and medication-related causes (iron supplementation is a common culprit). 1, 2

Important Considerations

• Constipation in pregnancy results from increased progesterone levels slowing GI motility, mechanical compression from the gravid uterus (especially third trimester), and low dietary fiber intake. 2
• Screen for hemorrhoids, which occur in approximately 80% of pregnant women and may complicate constipation management. 2
• Hydrocortisone foam has been shown to be safe in the third trimester for hemorrhoid treatment if needed. 2

Why This Recommendation Prioritizes Patient Safety

The principle of "first, do no harm" is paramount in pregnancy. While linaclotide is highly effective for IBS-C and chronic constipation in the general population 1, 4, 5, 6, the lack of adequate human pregnancy data and the availability of multiple safe, well-studied alternatives make it an inappropriate choice. 1, 3 The stepwise approach outlined above provides effective symptom relief while using only medications with established safety profiles in pregnancy. 1, 2