# FDA Advisory Committee Meeting July 10, 2013 of the Drug Safety and Risk Management Advisory Committee for Lotronex



## Jeffrey Roberts (Apr 15, 1987)

The Food and Drug Administration Amendments Act of 2007 requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On July 10, 2013, the Agency plans to discuss the risk management of Lotronex (alosetron hydrochloride) tablets, Prometheus Laboratories Inc., which is approved for the treatment of women with severe diarrhea predominant irritable bowel syndrome (IBS-d). The Agency will seek the committee's comments as to whether the REMS with ETASU for this drug assures safe use, is not unduly burdensome to patient access to the drug, and to the extent practicable, minimizes the burden to the health care delivery system.

Meeting Materials:

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/ucm332858.htm

Webcast information:

https://collaboration.fda.gov/dsarm71013/


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## Jeffrey Roberts (Apr 15, 1987)

Our letter submitted to the FDA Advisory Committee Meeting.



> Irritable Bowel Syndrome Self Help and Support Group
> 
> www.ibsgroup.org
> 
> ...


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## Jeffrey Roberts (Apr 15, 1987)

#FDA Advisory Mtg vote results about #Lotronex REMS for #IBS-D: Majority votes REMS updated to include e-pharm mgmt & eliminate sticker.

Most Advisory Cmte members believe patient signature be kept as very important to indicate that patients understand risks #Lotronex #IBS

Only the #FDA Advisory Cmte Patient Rep. member voted to eliminate the patient signature. #Lotronex #IBS


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## Jeffrey Roberts (Apr 15, 1987)

I am disappointed in #FDA Advisory Cmte vote. Severe burden on patient to find doctor who will prescribe. Signature is irrelevant. #Lotronex #IBS


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