FDA warns of contamination of multiple drugs, dietary supplements … – Bucks County Courier Times

Liquid vitamins for infants and children are among several supplements and drugs that the U.S. Food and Drug Administration is advising consumers and health care professionals not to use due to risk of severe infection.

The FDA is advising against using any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands, due to potential contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for severe patient infection.

The drug and dietary supplement products made by PharmaTech include liquid docusate sodium drugs (stool softeners), as well as various dietary supplements including liquid vitamin D drops and liquid multivitamins marketed for infants and children.A lab test done by the Centers for Disease Control and Prevention (CDC) found a strain of B. cepacia in samples of the stool softeners.

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

According to the CDC, B. cepacia poses the greatest threat to hospitalized patients, critically ill patients and people with health problems such as weakened immune systems and chronic lung diseases. The symptoms of B. cepacia infections vary widely from none at all to serious respiratory infections. It can spread from person-to-person by direct contact and is often resistant to common antibiotics.

Consumers, pharmacies and health care facilities should immediately stop using and dispensing all liquid drug and dietary supplement products manufactured by PharmaTech and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands.

This is not the first time the FDA has advised patients against using liquid docusate (stool softening) drug products manufactured at PharmaTech's Davie, Florida, facility. The FDA issued an advisory in 2016 after the products were implicated in the CDC's public health investigation into a multistate outbreak of B. cepacia infections.

The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of drugs and dietary supplements products to the FDAs MedWatch Adverse Event Reporting program:

Complete and submit the report online at http://www.fda.gov/medwatch/report.htm; or download and complete the form, then submit it via fax at 1-800-FDA-0178.

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FDA warns of contamination of multiple drugs, dietary supplements ... - Bucks County Courier Times