FDA provides reassurance over contaminated cough medicine

In a move which will be welcomed by the pharmaceutical community, the US Food and Drug Administration (FDA) has said there is no indication that contaminated cough and paracetamol medicines have entered the US supply chain.

The medicines are understood to have caused deaths of children in Gambia last year, following an investigation led by the US Center for Disease Control and Prevention.

The investigation reported that the medicines in question contain toxic levels of diethylene and ethylene glycol, which has led to acute kidney injury among 78 children in Gambia.

“We will continue to monitor the situation and keep the public and health care professionals updated of any changes in status to the US market,” Patrizia Cavazzoni, director for FDA’s Center for Drug Evaluation and Research, said.

The latest moves follow concerns first flagged by the World Health Organization last autumn, when it sent out an alert saying four cough syrups containing toxic levels of diethylene and ethylene glycol should be withdrawn from distribution.

In January, the WHO said it had expanded its investigation into contaminated cough syrups linked to deaths from acute kidney injury in Gambia, Indonesia and Uzbekistan to four additional countries, and called on governments more widely to ensure that medicines for sale are approved by competent authorities.

Samples of the syrups, produced by six different companies in India and Indonesia, were found to be contaminated with a known toxin, either diethylene glycol or ethylene glycol. The companies in question have either denied that their products have been contaminated or declined to comment while investigations are ongoing.