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U.S. Department of Health and Human Services

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Lotronex (alosetron hydrochloride) Information

FDA announced on June 7, 2002, the approval of a supplemental New Drug Application (sNDA) that allows restricted marketing of Lotronex (alosetron hydrochloride), to treat only women with severe diarrhea-predominant irritable bowel syndrome (IBS). The approved sNDA for Lotronex includes a risk management program to ensure patients and physicians are fully informed of risks and possible benefits of Lotronex.

Note: Prometheus acquired the NDA for LOTRONEX from GlaxoSmithKline (GSK) in January 2008.

 

Do Not Buy Lotronex Over the Internet

  • You should not buy Lotronex over the Internet because you will bypass important safeguards designed to protect your health (and the health of others).

  • Lotronex has special safety restrictions on how it is distributed to the public. Also, drugs purchased from foreign Internet sources are not the FDA-approved versions of the drugs, and they are not subject to FDA-regulated manufacturing controls or FDA inspection of manufacturing facilities.  


To learn more about buying drugs safely, please see Buying Prescription Medicines Online: A Consumer Safety Guide   
 


Adverse reactions or quality problems experienced with the use of this drug may be reported to the FDA's MedWatch Adverse Event Reporting program using the contact information at the bottom of this page. 

 

Contact FDA

1-800-332-1088
1-800-FDA-0178 Fax
Report a Serious Problem

MedWatch Online

Regular Mail: Use postage-paid FDA Form 3500

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