Lower Strength Linzess Approved
January 26, 2017 - The U.S. FDA approved a new lower strength of Linzess® (linaclotide), jointly marketed by Allergan and Ironwood Pharmaceuticals. Like the 145mcg capsules, which were approved in 2012, the new 72mcg capsules are indicated to treat adults who have chronic idiopathic constipation (CIC). Over 30 million Americans are believed to have CIC, which has no apparent cause. Recommended dosing for CIC is one 72mcg or 145mcg capsule at least one-half hour before breakfast each day. A 290mg strength is approved for treating adults who have irritable bowel syndrome with constipation (IBS-C). A guanylate cyclase-C (GC-C) agonist, Linzess increases the amount of fluids in the intestines, speeds up movement of bowel contents and lessens abdominal pain. Due to the possibility that it may cause dehydration, Linzess should not be used for patients under the age of 18. The 72mcg strength is projected to be released in first quarter 2017.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.