Government suspends sale of cisapride

Government suspends sale of cisapride

JAKARTA (JP): The government has decided to suspend the sale
of the gastric drug cisapride, pending the completion of an
investigation into the risks of taking the medicine.

Director General for Food and Drug Control Sampurno said on
Friday that the suspension would be effective from July 14 until
the National Board of Health completes its investigation and
review of the probe's results.

"The investigation and review will take approximately two to
three months, after which the board will decide whether or not to
ban the product," Sampurno said.

He added cisapride producers in Indonesia would be given 10
days between July 4 and July 14 to withdraw their products from
market shelves.

Cisapride is a drug prescribed for the treatment of severe
heartburn experienced by adult patients with gastroesophageal
reflux disease (GERD).

It is also used to treat gastroparesis, functional dispepsia
and feeding disorders.

At least 80 reports of death and 314 reports of heart rhythm
abnormalities have been associated with the drug, according to
the U.S. Food and Drug Administration (FDA).

Most cases occur in patients who are taking other medication
or are suffering from underlying conditions which are known to
increase the risk of heart rhythm disorder associated with
cisapride, the FDA said in a statement.

Sampurno said in Indonesia the drug goes under more than 30
brand names, including Acpulsif, Bellaprid, Disflux, Dispep,
Ethiprid, Guarposid, Laprid, Precis, Prepulsid, Presid, Pridesia,
Pronetic, Rapulid, Stimulit, Vomiflux and Vomiprid.

Merdias Almatsier, the chairman of the Indonesian Doctors
Association (IDI), said no complaints had been lodged so far from
patients in Indonesia using the drug.

The New Jersey-based company Janssen Pharmaceuticals announced
the withdrawal of its cisapride product, under the name of
Propulsid, from the market as of July 14.

Janssen Indonesia medical affairs manager Yanwar Hadiyanto
said the decision did not mean that the company was stopping
production of the drug in the United States, but was merely
limiting its access.

"Propulsid can not be replaced by other medicine in some
illnesses, therefore, it remains available to the public but
through strict control," he said.

A doctor can only have access to the drug after filling in a
form authorized by the FDA and Janssen, he explained.

Yanwar said the problems had occurred due to inappropriate use
of the medicine.

Of approximately 46 million people in the United States who
take Propulsid in a month, half of them violated the prescribed
indications, and 11 percent used above the prescribed dosage of a
maximum 40 milligrams, Yanwar added.

He attributed the absence of complaints from Indonesian
patients to the habit of using a lower dosage of medicines.
Asians need a smaller dosage of medicine than Europeans, Yanwar
said. (10)