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Zelmac safety database
11,000 healthy volunteers or patients exposed to Zelmac*
– maximum daily dose up to 200 mg in healthy volunteers
*Prior to marketing approval Novartis, data on file
2,690 patients treated for at least 85 days*
302 IBS patients treated for at least 335 days*
No clinically relevant abnormalities in clinical chemistry, hematology or biochemistry
Adverse events (≥0.5%) leading to discontinuation in phase III studies
Patients (%)
EventsPlacebo(n=1,589)
Zelmac all doses(n=2,446)
Total 5.2 7.0
Diarrhea 0.3 1.6
Abdominal pain 1.3 1.6
Nausea 0.8 0.4
Flatulence 0.6 0.8
Headache 0.8 1.0
Dizziness 0.6 0.7
Reproductive disorders 0.6 0.7
Other 0.2 0.2
Pooled data Studies 1, 2 and 3 Novartis, data on file
Cardiac safety assessment
>10,000 ECG tracings made in Zelmac clinical studies1
1Novartis, data on file2Morganroth et al. 2002
QTc interval and other ECG changes similar in Zelmac and placebo groups2
Data confirm pre-clinical findings that at therapeutic doses, Zelmac is devoid of ECG effects2
FDA has found out that Zelmac causes Ischemic Colitis and severe diarrhea
Doctor received the medscape update on the 24th of April 2004
FDA asked for a revision in the label of Zelnorm (US) for the following
1. Addition of a new warning:– "Serious consequences of diarrhea, including
hypovolemia, hypotension and syncope have been reported in the clinical studies and during marketed use of Zelmac.
– In some cases, these complications have required hospitalization for rehydration
– Zelmac should not be initiated in patients who are currently experiencing or frequently experience diarrhea
– (this is what we are clearly stating on our promotion)
ON IC…
Zelmac should be discontinued immediately in patients who develop symptoms of ischemic colitis:
such as :• rectal bleeding• bloody diarrhea • new or worsening abdominal pain
Patients developing these symptoms should be evaluated promptly and have appropriate diagnostic testing performed.
ON IC…
Zelmac should be discontinued immediately in patients who develop symptoms of ischemic colitis:
such as :• rectal bleeding• bloody diarrhea • new or worsening abdominal pain
Patients developing these symptoms should be evaluated promptly and have appropriate diagnostic testing performed.
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