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Prepulsid Alert

24 March 2000

Prepulsid Alert

Ministry of Health controls around the use of the medicine Prepulsid prevent it being prescribed to people most at risk of the drug's known side effects.

The Ministry's reassurance follows news that Janssen Pharmetic has agreed to stop distributing the medicine, used to treat severe gastro-intestinal conditions, after concerns about its safety.

Janssen's decision followed the Food and Drug Administration receiving 341 reports of heart rhythm abnormalities including 80 deaths associated with its use. Most of these side effects occurred in patients taking other medications or suffering from other medical conditions known to increase the risk of heart rhythm problems with cisapride.

It will continue to be available to Americans through doctors until July, and thereafter on the recommendation of gastro-enterologists.

New Zealand's Centre for Adverse Reactions Monitoring at Otago University has received 19 reports of Prepulsid side effects since 1991. None of these side effects resulted in death and only one case involved heart rhythm disturbance.

Between 100,000-150,000 New Zealanders use Prepulsid. Worldwide, 190 million patients have been prescribed Cisapride since it was first introduced in 1988.

Ministry spokesperson Dr Stewart Jessamine said that there were stricter controls on the prescription of Prepulsid (generic name Cisapride) in New Zealand, compared to its regulation in America.

In New Zealand a GP needs a specialist's recommendation before he can prescribe it to a patient. In America GPs have been able to prescribe it.

"The Ministry has also issued advice to ensure that GPs and specialists are aware of the possible side effects of Prepulsid should it be given to people with heart abnormalities or on particular medicines," Dr Jessamine said.

The advice warned against prescribing Prepulsid to people taking medications such as erythromycin, fluconazole, clarithromycin and amiodarone or other substances which can cause heart rhythm distrubance. It also said people predisposed to heart rhythm problems or with liver abnormalities.

Dr Jessamine said in light of the decision in America the Ministry would again review the safety of Prepulsid in conjunction with the Medicines Adverse Reactions Committee.

"In the interim we would like to assure patients that prescribers in New Zealand are aware of the need to avoid prescribing Prepulsid to groups most at risk from side effects.

"We would also like to stress that the situation that is occurring in America is not the case here, due to our tighter controls and the awareness of prescribers.

"However we will be seeking further information. In the interim we suggest patients taking Prepulsid to discuss with their doctor when their prescription is due for renewal if they have any risk factors and whether Prepulsid is the most appropriate medication for their condition," Dr Jessamine said.

ENDS

For further information contact; Sue McCabe, Media Advisor, 04 496 2167 or 025 495 989 Internet Address; http://www.moh.govt.nz/media.html


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