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WHO says drug caused PIC deaths

March 22, 2013

LAHORE, March 21: The World Health Organization (WHO), too, has blamed Isotab for the death of more than 200 patients of the Punjab Institute of Cardiology in Lahore in early 2012, saying that a 25kg drum of pyrimethamine had been mixed ‘accidentally’ into a batch of the cardiac medicine during manufacturing in Karachi.

In its report finalised on Wednesday, it said that more than “200 people died and around 1,000 became seriously ill” in Pakistan after taking contaminated cardiac medicine – Isotab – manufactured by Efroze, a Karachi-based company. The contaminated drug was later distributed by the PIC to its patients.

The WHO is the third forum after the Punjab government and the Defective Drug Inquiry Tribunal of the Lahore High Court to complete a report on the PIC scam.

The WHO Headquarters in Geneva has sent its report to the Punjab government and other relevant authorities, a copy of which is available with Dawn.

In its report the WHO praised the Punjab government for immediately retrieving drugs distributed to 46,000 patients. “The WHO has described it as world’s largest retrieval of drugs so far,” an official told Dawn.

He said 8.8 million Isotab tablets were manufactured and 400,000 of these were declared contaminated. As many as 100,000 had been distributed to patients registered with the PIC when deaths were reported.

According to the WHO report, bleeding from the mouth and gastrointestinal tract, strange dark marks on the skin and extremely low levels of white blood cells and platelets were symptoms in patients who were admitted to hospitals across Lahore in early December 2011.

At first, doctors suspected they were facing a new outbreak of dengue, but they were baffled when they did not find any dengue symptoms in them. By mid-January, 25 people had died from this mysterious illness and hundreds more crowded emergency rooms throughout the city.

The report said a team of doctors established a common link: these patients had been taking locally-manufactured cardiovascular medication distributed free by the PIC.

Suspecting an adverse reaction by drug overdose or contamination, the Punjab health secretary immediately recalled five suspected drugs distributed to around 46,000 patients. Preliminary tests were done in Pakistan and then samples of these medicines were sent to laboratories around the world.

“Media reports emerging from Pakistan were picked up by WHO staff in Islamabad and Geneva. Despite some conflicting stories, it was obvious that Pakistan was facing a very serious health issue,” says Michael Deats from WHO’s Department of Essential Medicines and Health Products.According to the report, the government of the Punjab made an urgent request for assistance from WHO for experts in pharmacology and medicines regulations.

It said, on January 31, the United Kingdom Medicines and Healthcare Products Regulatory Agency announced that it had identified the contaminant. Large quantities of anti-parasitic drug pyrimethamine were found in a batch of cardiovascular medication called Isotab.

Fourteen times above the normal dosage level, pyrimethamine was causing severe folate deficiency, destroying platelets in bone marrow and triggering heavy internal bleeding. Fortunately, high doses of calcium folinate can reverse the toxic effects of the overdose and the hospitals were able to start treating patients immediately.

A WHO team accompanied by local officials visited the manufacturing site of Isotab where it was established that a 25kg drum of pyrimethamine had gone missing and been mixed into a batch of the cardiac medicine, the report said.

“We were very lucky that the entire batch of contaminated drugs was distributed from just one hospital and that it is one of the few in Lahore that uses electronic records so patients could be traced more easily. It was also fortunate that the contaminant was identified quickly and a cure was known and available immediately. Many lives were saved once the contaminant was identified,” says Deats.