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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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Our letter submitted to the FDA Advisory Committee Meeting.

Irritable Bowel Syndrome Self Help and Support Group

www.ibsgroup.org

Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417

Re: July 10, 2013: Meeting of the Drug Safety and Risk Management Advisory Committee Meeting about Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU) of Lotronex (alosetron) for IBS-D

The IBS Self Help and Support Group, an IBS patient advocacy group, testified to the FDA in 2002 as an organizing member of the then Lotronex Action Group (LAG), demanding access to Lotronex, on behalf of patients.

We have always been deeply concerned about how perceptions of diarrhea predominant Irritable Bowel Syndrome (IBS-D) may be affecting the Food and Drug Administration's consideration of risks and benefits related to use of Lotronex.

Although IBS-D is viewed as a non-fatal disease, its effects are often debilitating. The typical sufferer of IBS-D is a female with primary symptoms including multiple and daily explosive diarrhea attacks and severe daily abdominal discomfort. Many of our members, who have been lucky enough to gain access to Lotronex have found Lotronex to be the only effective treatment for IBS-D, enabling themselves to assume normal adult lives for the first time.

Since Lotronex was returned to the market in 2002 we hear very often from our members enquiring about doctors who would be willing to prescribe it. We are led to believe that Lotronex's REMS have created an enormous burden for both patients and physicians. For patients they must seek out a prescribing physician often traveling great distances and seeing multiple physicians before finding one whom will prescribe it. Physicians must assume an unwarranted perceived risk for prescribing Lotronex, not even in place for controlled medications such as narcotics. Why is this type of risk strategy still in place for Lotronex well over ten (10) years since it was returned to the market?

Lotronex's post market safety profile has been exemplary since it returned to the market because it has been marketed and prescribed responsibly. Despite this, we have witnessed fewer physicians willing to prescribe the medication due to the current REMS. Many physicians who have indicated that they are not willing to take the time to either enroll in the program or assume the unwarranted risk of prescribing a drug that has been so maligned.

We believe that the FDA should re-examine the current REMS to reduce the onerous and burdensome process demanded from patients and physicians. IBS-D, while not directly fatal, causes severe damage to the quality of the lives of the sick and their families. Patients afflicted with this condition should have easier access to Lotronex than the current REMS provide. We believe an easement of the REMS will further aid others who have failed to gain access to this very helpful medication.

Sincerely,

Jeffrey D. Roberts, Founder

IBS Self Help and Support Group
 

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#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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