The World Health Organization (WHO) has identified contaminated medicines from Pakistan and has issued a global alert after discovering contaminated syrups and suspension medicines in multiple countries. The affected products, manufactured by Pharmix Laboratories in Pakistan, were found to contain ‘unacceptable levels’ of the contaminant ethylene glycol.
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Affected Regions By Contaminated Medicines From Pakistan
The contaminated medicines have been identified in WHO regions including the Americas, Eastern Mediterranean, South-East Asia, and the Western Pacific. The issue was initially detected in the Maldives and Pakistan, with subsequent reports emerging from Belize, Fiji, and Laos. Pharmix Laboratories, the manufacturer, has not yet responded to the allegations.
The medicines in question are liquid formulations containing active ingredients to treat various health conditions. The WHO disclosed that the contaminant levels of ethylene glycol in these products exceeded acceptable limits. This revelation follows previous warnings from the World Health Organisation about similarly contaminated medicines from India and Indonesia, which were linked to the tragic deaths of approximately 300 children globally last year.
Vigilance and Testing Urged
While no adverse events related to the Pakistan-made syrups have been reported to the WHO, the organization has urged countries to heighten vigilance. The statement advises countries to test products manufactured by Pharmix Laboratories between December 2021 and December 2022.
Discovery and Actions Taken
The contamination was initially discovered in Alergo syrup during a routine examination by the Maldives Food and Drug Authority in November. Subsequent confirmation by the Australian regulator prompted a follow-up inspection at Pharmix manufacturing facilities by the Drug Regulatory Authority of Pakistan. The inspection revealed contamination in several other products, leading to a cease in the production of all oral liquid medicines by Pharmix. A recall alert was issued in November.
A total of 23 batches of affected products, including Alergo syrup, Emidone suspension, Mucorid syrup, Ulcofin suspension, and Zincell syrup, have been identified. Notably, only Alergo syrup has been found outside Pakistan.
Severity of Contamination
The contamination levels ranged from 0.62 percent to 0.82 percent, surpassing the accepted level of not more than 0.10 percent, as outlined in the alert. The affected products are designed to treat allergies, coughs, and various health issues.
“The substandard products referenced in this alert are unsafe, and their use, especially in children, may result in serious injury or death,” warned the WHO, emphasizing the urgency of addressing this public health concern.