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)