DOH to hospitals: Report adverse reactions to dialysis drug

MANILA, Philippines - The Department of Health (DOH) urged all hospitals yesterday to report to the Food and Drug Administration (FDA) if they have patients who experienced adverse reactions to a dialysis drug.

According to DOH spokesman Lyndon Lee Suy, the heparin sodium 1000 IU/ml solution for infection with brand name Meparin 5 was confirmed to have caused the chills experienced by 44 dialysis patients at the National Kidney and Transplant Institute (NKTI) during the last week of May.

“We have received some reports patients in other facilities also experienced unusual chills. We are validating this and we are also calling on other hospitals to report any adverse reaction that their patients had,” he said.

The FDA also reported that batches of the drug failed the sterility test and grown two types of bacteria after two weeks of examination.

This prompted the FDA to order the recall not only of Meparin 5 but of 500 IU/ML solution for injection under brand name Meparin 25, since the problem seems to have arisen from the manufacturing side, Lee Suy said.

He said the FDA is studying the possible sanctions that could be imposed on the importer of the product, manufactured by MedChem International Ltd. of India.

In FDA Advisory 2014-049, executive director Kenneth Hartigan-Go has advised all health facilities in the country to stop using the products “regardless of the batch.”

He added that FDA will do tests on all products manufactured by MedChem that are in the Philippine market. Any adverse reaction experienced from these products could be reported immediately to FDA by visiting www.fda.gov.ph.