In two recent articles, Gastroenterology & Endoscopy News incorrectly stated that Linzess (linaclotide), which received FDA approval last August to treat chronic idiopathic constipation and to treat irritable bowel syndrome with constipation, is indicated for individuals “who do not respond to standard treatments.” This phrase is inconsistent with the FDA-approved indication for Linzess, which does not contain this stipulation.
 
“It is not necessary to fail another therapy before beginning treatment with Linzess,” noted Douglas S. Levine, MD, vice president of Medical Scientific Affairs, Ironwood Pharmaceuticals, which co-markets Linzess with Forest Pharmaceuticals.
 
The Prescribing Information for Linzess states: Linzess is a guanylate cyclase-C agonist indicated in adults for treatment of:
  • Irritable bowel syndrome with constipation (IBS-C)
  • Chronic idiopathic constipation
 
Both articles have been updated to reflect this correction:
FDA Approves Linzess To Treat IBS and Chronic Constipation,” by Maureen Sullivan. Gastroenterology & Endoscopy News October 2012;63:64
Linzess, New Drug for IBS and Chronic Constipation, Now Available in Pharmacies.” Gastroenterology & Endoscopy News January 2013;64:38
 
For more detailed information about Linzess, see the FDA press release at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317505.htm, or see the Prescribing Information at www.frx.com/pi/linzess_pi.pdf.