FDA issues warning vs contaminated kids’ drugs

PHOTO: Food and Drug Administration (FDA) official facebook page

MANILA, Philippines — The Food and Drug Administration (FDA) has warned the public about unregistered medicines for children that were flagged by the World Health Organization (WHO) as contaminated with toxic chemicals.

In an advisory dated Dec. 28, 2023, the FDA said that five pediatric drug products manufactured by Pharmix Laboratories Ltd. were contaminated by diethylene glycol and ethylene glycol that may lead to various symptoms when consumed above the acceptable limit.

Adverse events include vomiting, diarrhea, abdominal pain, altered mental state and kidney injury, which may lead to death, the FDA noted.

The products raised by the WHO as “substandard” were Alergo syrup, Mucorid syrup, Ulcofin suspension, Zincell syrup, and Emidone suspension. All were found to be sold in Pakistan, Laos, Maldives, Fiji, and Belize.

Syrups and suspension are both medications in liquid form, with varying properties.

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Don’t buy from abroad

“This is to emphasize that the abovementioned drug products are not registered with the FDA. However, it is important to detect and remove these products from circulation to prevent harm to patients,” said the regulatory agency.

The FDA’s counterpart agency in Pakistan has ordered a recall of the said products and to halt production of the same, according to the FDA.

“Substandard products are [those] that fail to meet either their quality standards or specifications,” it noted.

It urged manufacturers of liquid dosage forms, especially those containing propylene glycol, polyethylene glycol, sorbitol and glycerin to have their products undergo testing before production.

No adverse effects from the medications have been reported to date, the FDA said.