Zelmac® is a prescription medicine registered by HSA in 2002 for use in the symptomatic treatment of irritable bowel syndrome (IBS) in female patients. It is also licensed for the treatment of chronic constipation of unknown cause in patients less than 65 years of age.
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Recent Safety Findings
A recent pooled analysis of 29 short-term, randomised, clinical trials involving 18,000 patients by Novartis identified an increase in the number of cardiovascular ischemic events in patients treated with Zelmac® when compared to placebo. These events include heart attacks, stroke and angina. Thirteen patients (or 0.1%) in the Zelmac® treated group had confirmed cardiovascular adverse events compared to 1 (or 0.01%) in the placebo treated group. The majority of the patients who experienced these adverse events had risk factors for heart disease such as history of high blood pressure, high cholesterol.
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HSA’s Advisory
HSA advises patients taking Zelmac® to stop taking the drug and consult their doctor to discuss alternative treatment options for their condition. Patients who are taking Zelmac® and experiencing severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking or other symptoms of heart attack or stroke, should seek immediate medical attention.
For those patients in whom no other treatment options are available and where the benefits of treatment with Zelmac® outweighs the risks, HSA is working with Novartis to allow Zelmac® to be made available to such patients through a special access avenue.
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