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Prometheus Announces Co-Pay Assistance Savings Program for LOTRONEX(R) (alosteron HCl) Tablets
Date:9/9/2009

Clinical studies have not been performed to adequately confirm the benefits of LOTRONEX in men. Safety and effectiveness in pediatric patients have not been established. Use of LOTRONEX is not recommended in the pediatric population, based upon the risk of serious complications of constipation and ischemic colitis in adults.

LOTRONEX has a boxed warning regarding serious gastrointestinal adverse events that have been reported with the use of LOTRONEX. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalizations, blood transfusions, surgery and fatalities. LOTRONEX should be discontinued immediately in patients who develop constipation or symptoms of ischemic colitis. LOTRONEX should not be resumed in patients who develop ischemic colitis. Physicians should instruct patients who report constipation to immediately contact them if the constipation does not resolve after discontinuation of LOTRONEX. Patients with resolved constipation should resume LOTRONEX only on the advice of their treating physician.(1)

Contraindications to LOTRONEX include constipation, history of severe bowel or hepatic disorders, lack of understanding of Patient-Physician Agreement and concomitant use of fluvoxamine.

New ACG Recommendations Published for IBS

The American College of Gastroenterology (ACG) recently published a new evidence-based systematic review of the management of IBS. After conducting a comprehensive meta-analysis of IBS therapies, the ACG IBS Task Force concluded that the benefit and risk balance for LOTRONEX is most favorable in women with severe IBS and diarrhea who have not responded to conventional therapies (Grade 1B).(2)

Only physicians who have enrolled in the Prometheus Prescribing Program for Lotronex, based on their understanding of the benefits and risks, should prescribe LOTRONEX. The Prescribing Program for Lotronex was imple
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SOURCE Prometheus Laboratories Inc.
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