Warning aired against tainted dialysis drugs
FDA director general Dr. Kenneth Go. Photo from www.fda.gov.ph
MANILA, Philippines—The Department of Health (DOH) is calling on hospitals to report cases of kidney patients who suddenly develop chills and other unusual reactions while undergoing dialysis.
The health agency made this appeal after the Food and Drug Administration (FDA) ordered the recall of a brand of a blood thinner—Meparin 5—found to be contaminated and suspected to be the culprit that caused chills among 44 patients undergoing dialysis at the National Kidney and Transplant Institute in Quezon City last month.
In an interview with reporters, DOH spokesperson Dr. Lyndon Leesuy said the health agency has also received reports from other hospitals in Metro Manila and neighboring provinces that their kidney patients experienced chills while undergoing dialysis.
FDA acting Director General Kenneth Go said these hospitals were from Batangas, Bulacan and Valenzuela.
“We encourage hospitals to make a report to the FDA so that they can also investigate. It might have been caused by the same product or it might be another product so we may need to investigate as well,” said Leesuy.
“We have received some reports already and we are already validating if these hospitals used the same product,” he added.
The health official also said there could be other dialysis centers in the country that had the same experience in the past with the blood thinner solution, manufactured by India-based Medchem International Ltd.
Meparin 5, used to prevent blood clotting in patients during dialysis, grew two bacteria during the sterility test conducted by the FDA.
Go earlier said that the manufacturer will be held liable for the contaminated product but he would “deal with the matter later on.”
Leesuy said the two agencies were still “exploring” what sanctions could be imposed on the manufacturer and other companies involved in the distribution of the contaminated drug.
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