Tag Archives: IBS-C

FDA Approves Higher Dosage of Linaclotide for IBS-C and ByHeart Formula Recall Due to Botulinism

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A Brooks. HCPLive 11/5/25: FDA Approves Linaclotide (Linzess) Capsules for Pediatric IBS-C

An excerpt:

The US Food and Drug Administration (FDA)  has approved Ironwood Pharmaceuticals’ linaclotide (Linzess) capsules for pediatric patients ≥ 7 years of age with irritable bowel syndrome with constipation (IBS-C), making it the first treatment approved for IBS-C in this patient population.1…

The approval for pediatric IBS-C was supported by extrapolation of efficacy from adequate and well-controlled studies in adults and a 12-week double-blind, randomized, parallel-group trial in pediatric patients 7-17 years of age who met modified Rome III criteria for child/adolescent IBS-C. The recommended dosage for this indication is 145 mcg orally once daily.1…

In 2023, the FDA approved linaclotide for the treatment of pediatric patients aged 6-17 years with functional constipation at a recommended dosage of 72 mcg orally once daily. 

Reference: US Food and Drug Administration. FDA approves 1st drug for children 7 years and older with irritable bowel syndrome with constipation. November 5, 2025. Accessed November 5, 2025. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-1st-drug-children-7-years-and-older-irritable-bowel-syndrome-constipation

Also, NBC news (11/08/25): ByHeart baby formula recalled amid 10-state outbreak of infant botulism The U.S. Food and Drug Administration said the outbreak includes 13 hospitalizations since August of children who consumed ByHeart Whole Nutrition Infant Formula. No deaths have been reported.

The recall includes two lots of the powdered formula with Dec. 1 “use by” dates, the FDA said in a statement Saturday. The lot numbers are 206VABP/251261P2 and 206VABP/251131P2…The FDA says ByHeart makes up less than 1% of the baby formula sold in the U.S.

Chicago Botanic Garden

Briefly Noted: Kiwi for IBS-C

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R Gearry et al. AJG 2022. DOI: 10.14309/ajg.0000000000002124.Open Access! Consumption of 2 Green Kiwifruits Daily Improves Constipation and Abdominal Comfort—Results of an International Multicenter Randomized Controlled Trial

Participants included healthy controls (n = 63), patients with functional constipation (FC, n = 60), and patients with constipation-predominant irritable bowel syndrome (IBS-C, n = 61). Mean age 35 years.

Key findings: Consumption of green kiwifruit was associated with a clinically relevant increase of ≥ 1.5 CSBM (complete spontaneous bowel movement) per week (Functional constipation; 1.53, P < 0.0001, IBS-C; 1.73, P = 0.0003) and significantly improved measures of GI comfort (GI symptom rating scale total score) in constipated participants (FC, P < 0.0001; IBS-C, P < 0.0001)

Related blog post: Small Study: Kiwi For Constipation

Relooking at Medications for Constipation-Predominant Irritable Bowel Syndrome

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A recent study (CJ Black et al. Gastroenterol 2018; 155: 1753-63) examined the effectiveness of secretagogues for constipation-predominant irritable bowel syndrome (IBS-C).  The authors conducted a systematic review and network meta-analysis with 15 eligible randomized controlled trials (8462 patients).

Key findings:

  • Linaclotide (290 mcg per day) was ranked first in efficacy using the end point recommended by the FDA for IBS-C trials
  • Tenapanor (50 mg twice a day) was ranked first for bloating
  • Plecanatide (6 mg per day) ranked first for safety
  • Diarrhea was significantly more common with all of the secretagogues except for lubiprostone; nausea was significantly more common with lubiprostone

The authors acknowledge the limitations in comparing medicines without direct head-to-head trials (which may never occur).  They state that linaclotide being superior to other treatments had a probability of 88%.

My take: This study indicates that linaclotide may be more likely to be effective than other IBS-C medications; all of these secretagogues have been shown to be superior to placebo.

In this same issue, pgs 1666-9 (J Ruddy), a patient describes her long journey with abdominal pain/GI symptoms.  She describes her initial experiences with physicians who were dismissive and not attentive. Ultimately, a physician listened to her and  helped her improve after explaining that she had a postinfectious IBS and provided treatment.

Related study: S Ishague et al. BMC Gastroenterol 2018; 18:71.  This randomized controlled trial which compared a multistrain probiotic (Bio-Kult, n=181) to placebo (n=179).  The probiotic group had a 69% decrease in abdominal pain compared to a 47% decrease in placebo group.

Sunrise, Death Valley