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Lotronex for IBS-D restricted access removed by the FDA


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Jeffrey Roberts

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.

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Jeffrey Roberts
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.

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