Berita Ubat-ubatan
August 2000

Regulatory Control Beyond 2000

Separate Manufacturing Facilities For Cephalosporins

Warning Label for products - NSAID

Registration of Products Containing Insect Repellants

Warning for Products containing Hydroquinone

Actions To Be Taken Against Products Containing CISAPRIDE (PREPULSID)
Licensing Update - June 2000

The Changing Pharmaceutical and Traditional Medicine Premises Landscape: 1987 - 2000

Additional Indications Approved for Registered Products

GMP News

Quality Control Training Course

Sources of products registered with DCA As At 30.6.2000

New Products Approved for Marketing in Malaysia

NPCB officers to contact

Clinical Trials

On 23rd March 2000, the US FDA announced that Janssen Pharmaceutica  had decided to voluntarily stop marketing cisapride in the United States as of 14^th July 2000. This was because cisapride has been associated with serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes and QT prolongation. From July 1993 to December 1999, 341 such cases were reported, including 80 deaths. In approximately 85% of these cases, the events occurred when Prepulsid was used in patients with known risk factors. However, a limited access programme was proposed whereby the drug would be made available for patients who fail other treatment options and who meet clearly defined eligibility criteria.

Based on the feedback and opinions of   gastro-enterologists in Malaysia and after studying data obtained from various other countries, the Malaysian Drug Control Authority (DCA) at its 117^th meeting held on 24th August 2000 approved the following actions to be taken for products containing cisapride.

1. All products containing cisapride are to be recalled from wholesalers, community/retail pharmacies and clinics.
2. The indication is amended to -

To be used as a last-line therapy for patients who cannot be treated with alternative therapies and who meet the eligibility criteria as defined in the "Prescribing Assurance and Compliance Programme (Patient Screening Form)" in the following conditions:
 

• Neonates: Patients with refractory feeding intolerance
• Paediatrics: Refractory gastro-oesophageal reflux disease (GORD/GERD)
• Adults: GORD, gastroparesis

3. The package inserts for cisapride will be amended in accordance with the new indications and all contra-indications and drug interactions should be updated based on the latest information and information contained in the "Prescribing Assurance and Compliance Programme (Patient Screening Form)"

Cisapride should only be prescribed to qualified patients, selected according to the "Prescribing Assurance and Compliance Programme (Patient Screening Form)".

Registration Requirements :

1. Only specialists in the related fields are allowed to prescribe cisapride. Names of doctors allowed to prescribe cisapride will be submitted to the DCA by the registration holder.
2. Cisapride should only be used as a "last-line therapy" in accordance with the approved indications.
3. "Prescribing Assurance and Compliance Programme (Patient Screening Form)" should be filled for each patient prescribed with cisapride and this record will be used by the registration holder to monitor patients who are prescribed with cisapride.
4. The supply of cisapride from community/retail pharmacies is not allowed.
5. Doctors should inform patients of the side-effects and drug interactions of cisapride before prescribing the drug.
6. The registration holder, with the cooperation of specialists who prescribe cisapride, must monitor the adverse reactions from all users and submit all reports to the DCA immediately.