FDA: Drug linked to chills in kidney patients recalled
The National Kidney and Transplant Institute in Quezon City
MANILA, Philippines–Health authorities have ordered the recall of a brand of anticoagulant or blood thinner suspected to have caused chills among 44 patients undergoing dialysis at the National Kidney and Transplant Institute (NKTI) in Quezon City last month.
According to Food and Drug Administration (FDA) acting Director General Kenneth Hartigan Go, the Heparin Sodium (brand name Meparin 5) 1000 IU/milliliter solution for injection used to prevent blood clotting in patients during dialysis was found to be contaminated.
“The NKTI found out and ascertained that the possible heparin product they [were] using might be the possible suspect agent” in the case of the 44 patients, Go said, adding that the sodium solution failed a sterility test.
“It grew [two kinds of] bacteria which is not according to standard quality specifications. There should be no bacteria. Given the evidence on clinical symptoms, the cluster of cases seen in one place and laboratory confirmation, we have enough evidence to conclude that Meparin 5 is the agent that has to be recalled from all hospitals and pharmacies in the Philippines,” he stated in a phone interview.
According to the FDA official, the recall covers all batches of Meparin 5 which is manufactured by India-based Medchem International Ltd. and distributed by Pharma-Surrey International Inc.
“If it happens in one batch, there is a presumption that all other batches coming from the same production line in the company will be problematic. We cannot afford to take a chance. It might be another product or it might be [from] another batch but they are using the same facilities. We have not conducted a foreign audit of [the] outside supplier [so] we cannot be sure if this is a raw material problem, a manufacturing process problem, a handling problem or a pipe has been contaminated. Until we know for sure, we cannot allow this product to continue,” he said.
Go added that on top of hold and recall orders they issued against the product earlier, they were forced to confiscate stocks already out in the market following cases similar to that at the NKTI being reported in the provinces, particularly Batangas and Bulacan.
“We don’t have the entire picture yet but there are [cases] happening elsewhere and the common denominator is the company’s product.” he said.
Go said there were at least nine patients in Bulacan and 11 others in Batangas who also experienced chills while undergoing dialysis. They were found to have used Meparin 5 taken from the same batch as those used at NKTI.
As for the possible liability of the product manufacturer, the FDA chief stated that they would deal with the matter later on.
“For now, we will not make any judgment, we will deal with liability, penalties and violations later on. But we will study [the] involvement of other companies in the Philippines [behind the] importation, wholesaling and distribution of this product. We also want to do [a] foreign audit… and consult international organizations. And we want to contribute our report to other countries to see if they have similar events and to see how severe the situation is,” Go said.
On May 30, 44 kidney patients complained of chills as they were undergoing dialysis at the NKTI, prompting the hospital to shut down its outpatient hemodialysis center for two weeks. It reopened last June 9 and so far, there have been no similar incidents.
