Potential contamination in multiple brands of drugs, warns FDA

The US Food and Drug Administration has issued a warning to consumers and healthcare professionals to not use any liquid drug or dietary supplement products manufactured by PharmaTech and labelled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands.

This warning comes as a result of a potential contamination risk of the products with the bacteria Burkholderia cepacia (B. cepacia) and as such the risk of severe patient infection. The drugs that are potentially contaminated include liquid docusate sodium drugs (stool softeners) and various liquid dietary supplements marketed for infants and children.

“B. cepacia poses a serious threat to vulnerable patients, including infants and young children who still have developing immune systems,” said FDA commissioner Scott Gottlieb, MD. “These products were distributed nationwide to retailers, healthcare facilities, pharmacies and sold online — making it important that parents, patients and healthcare providers be made aware of the potential risk and immediately stop using these products.”

The Centers for Disease Control and Prevention (CDC) report that although B. cepacia shouldn’t cause serious medical issues for healthy people it does pose risk to hospitalised patients, critically ill patients and people with health issues.

Consumers, pharmacies and healthcare facilities are advised to stop using any of the products at risk of contamination immediately and the FDA encourages professionals or the public to report any adverse events or quality related issues to its MedWatch Adverse Event Reporting programme.