Four cough syrup products for children made in India were found to have been contaminated, and thought to be linked to the death of 70 children in Gambia

The World Health Organization identified these cough syrup products as – Promethazine Oral Solution BP, Kofexmalin Baby Cough Syrup, MaKOFF Baby Cough Syrup, and MaGrip N Cold Syrup, manufactured by Maiden Pharmaceuticals Ltd. based in Haryana, India.

The Philippine Food and Drug Administration said these four cough syrups are “not registered” with them.

However, the FDA issued an advisory last October 21 to alert the public of these cough syrup products “to detect and remove these products from circulation to prevent harm to patients.”

“All local government units (LGU) and law enforcement agencies (LEAs) … are requested to ensure that these substandard drug products are not sold or not administered to patients in their localities or areas of jurisdiction,” the FDA said in its advisory.

The advisory came 16 days after the WHO issued a Medical Product Alert on the four pediatric products. This after Gambia reported 66 child deaths from acute kidney injury. 

The public is advised to report if they encountered any of these cough syrups being sold in the market through the email: [email protected] or call the Center for Drug Regulation and Research at (02) 88095596.

What do we know about the 4 cough syrups

The WHO said “unacceptable amounts of diethylene glycol and ethylene glycol”  were found from samples of the four cough syrup products distributed in Gambia.

Diethylene glycol and ethylene glycol are chemicals meant for industrial use. When consumed, they may cause any of these toxic effects – abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death. 

The FDA said the Indian manufacturer “has not provided guarantees to WHO on the safety and quality of these products.”

“All batches of these products should be considered unsafe until they can be analyzed by the relevant National Regulatory Authorities,” the FDA said in its advisory.