Raffaella’s Literature Update
Dear Friends,
It is sad to share again cases of contamination that may compromise -or have compromised- the health of users of cough syrups, in particular of children.
First, the South African Health Products Regulatory Authority (SAHPRA) received a report from the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) regarding the detection of high levels of diethylene glycol in a batch of Benylin Paediatric Syrup. SAHPRA immediately contacted the South African manufacturer, Kenvue (formerly Johnson and Johnson) for a response. Following engagements with the manufacturer and in the best interest of the public, it was resolved that affected batches would immediately be recalled while an investigation is ongoing. See the preliminary information at this link: SAHPRA recalls two batches of Benylin Paediatric Syrup
Second, there is a new WHO Alert (attached), which refers to falsified DOW USP/EP PROPYLENE GLYCOL detected by the national regulatory authority in Pakistan. It is to be noted that the authentic DOW USP/EP PROPYLENE GLYCOL is a raw material (excipient) utilized in pharmaceutical and other manufacturing processes, adhering to the standards of the United States and European Pharmacopoeias (USP/EP) for medicinal use.
Third, I also attach a Commentary published in the AMA Journal of Ethics by Nallathambi and Cadwallader, about diethylene glycol-contaminated glycerin in cough syrups. As described in the abstract, “Glycerin is a commonly used excipient in medicines to improve texture and taste. Excipients are typically pharmacologically inactive ingredients contained in prescription and over-the-counter drugs that play a critical role in the delivery, effectiveness, and stability of active drug substances. The commentary first canvasses how contaminants enter the excipient supply chains. One way is by misleading labelling or intentional adulteration by manufacturers or suppliers. Another way is by human or systemic error. This commentary then discusses quality control testing and suggests the ethical and clinical importance of increased transparency in excipient supply chains“.
Please do not hesitate to share this information with potentially interested/concerned colleagues. Best,
Raffaella