Last Updated on December 23, 2023 by Hitesh Goyal
WHO Alert
In a recent announcement, the World Health Organization (WHO) has issued a global WHO alert regarding contaminated syrups and suspension medicines manufactured by Pharmix Laboratories in Pakistan.
This WHO alert, covering regions including the Americas, the Eastern Mediterranean, South-East Asia, and the Western Pacific, highlights the potential dangers posed by these products.
Identification and Origin
The WHO reports that the affected products, namely ALERGO Syrup, EMIDONE Suspension, MUCORID Syrup, ULCOFIN Suspension, and ZINCELL Syrup, were initially identified in the Maldives and Pakistan.
Subsequently, cases have been reported in Belize, Fiji, and the Lao People’s Democratic Republic.
Quality Control Issues
Samples of ALERGO syrup from five different batches underwent rigorous testing by the Maldives Food and Drug Authority (MFDA).
The results raised serious concerns, revealing unacceptable levels of diethylene glycol and ethylene glycol as contaminants.
Further laboratory tests by the Therapeutic Goods Administration of Australia confirmed contamination levels well above accepted limits.
Manufacturer’s Response and Regulatory Actions
Pharmix Laboratories, the manufacturer in question, underwent a thorough inspection by the Drug Regulatory Authority of Pakistan (DRAP).
The findings suggested the possibility of contaminants in other products and batches manufactured by Pharmix Laboratories.
As a precautionary measure, DRAP instructed Pharmix Laboratories to halt the production of all oral liquid dosage medicines.
Subsequently, on November 16, 2023, DRAP issued a recall alert for five different syrup medicines manufactured by Pharmix Laboratories.
Precautionary Measures by WHO
While no adverse effects have been reported to WHO thus far, the organization, out of an abundance of caution, recommends increased vigilance and testing for oral liquid dosage medicines produced by Pharmix Laboratories between December 2021 and December 2022.
WHO emphasizes that the substandard products mentioned in the alert are unsafe, especially for children, and may lead to serious injury or death.
Potential Health Risks and Toxic Effects
WHO warns that the usage of these contaminated products, particularly in children, can result in severe health issues.
Toxic effects may include abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
FAQs:
- Q: How were the contaminated syrups initially identified?
- A: The Maldives Food and Drug Authority (MFDA) conducted routine screening using the thin layer chromatography (TLC) test for diethylene glycol and ethylene glycol.
- Q: Are there any reported adverse effects linked to the affected products?
- A: As of now, no adverse effects have been reported to the World Health Organization (WHO).
- Q: What actions have regulatory authorities taken against Pharmix Laboratories?
- A: The Drug Regulatory Authority of Pakistan (DRAP) instructed Pharmix Laboratories to stop production, and a recall alert was issued for the affected syrup medicines.
- Q: What time frame does WHO recommend increased vigilance for?
- A: WHO recommends increased vigilance and testing for oral liquid dosage medicines produced by Pharmix Laboratories between December 2021 and December 2022.
- Q: What are the potential toxic effects of using these contaminated products?
- A: Toxic effects may include abdominal pain, vomiting, diarrhea, altered mental state, and acute kidney injury, which can be fatal.
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