An update from the FDA on the medication for IBS-D called Lotronex (alosetron hydrochloride) which is only marketed in the US.

Lotronex and approved generics are FDA approved for the treatment of irritable bowel syndrome in women whose predominant bowel symptom is diarrhea.

Although safety risks for Lotronex (alosetron hydrochloride) and approved generics still exist, FDA has determined the risk evaluation and mitigation strategies (REMS) programs for these drugs ARE NO LONGER NECESSARY to ensure the benefits outweigh the risks of ischemic colitis and serious complications of constipation.

https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/lotronex-alosetron-hydrochloride-information

 

Aside:  In 2002, myself & 10 other IBS patients testified at the FDA asking for Lotronex to be returned to the market as we deemed it safe if prescribed correctly. Fast forward 21 years and restricted access of a very well tolerated medication for IBS-D has been lifted. Thank you to the FDA.

Good news. I wonder what caused them to reevaluate their decision.

On 9/20/2023 at 8:17 AM, danb said:

Good news. I wonder what caused them to reevaluate their decision.

I believe there were no new adverse events reported that continued to require the guidance.

Dear Jeff, 🤩

I just came online now again after many years (since 2019). No thanks to Covid/Long Covid, I have not been able to participate in my old "hobbies". 

When I read your post right now, Tears came to my eyes.  You have been more than an inspiration to the entire iBS POPULATION. Your IBS support group

from the beginning days of the Internet HELPED and SAVED more lives than you will ever know. 

I am sorry I have not been in communication as I once was. Tonight I decided to take a look around and thought of Good OL' Lotronex vs Generic

and humanity EMERGE... and I just need you to know I have not forgotten and I never will. 

Sincerely with Love and Good Wishes to you and your family, ❤️

Lisa 

PS JEFF!!  Thank you for the GOOD NEWS re: REMOVAL OF restricted access.  sheessh, I have been gone way too long. I didn't even know this happened! 

PPS Jeff, I am still learning how to navigate this website.  So if I get lost somewhere or am delayed in response, please forgive me, Im not ignoring you or anyone 

🤔  😄