The U.S. Food and Drug Administration (FDA) is advising patients and healthcare professionals to not use any liquid products made by PharmaTech, LLC due to possible contamination with Burkholderia cepacia bacteria, which may cause serious infections in patients with chronic lung diseases, including cystic fibrosis (CF).
The regulatory agency previously had warned against using PharmaTech’s oral liquid docusate, after the Centers for Disease Control and Prevention detected a strain of the bacteria in the product following a 2016 multistate outbreak of infections. The latest safety alert covering all PharmaTech liquid products was issued after the FDA determined that other products may be contaminated.
However, determining which products were manufactured by PharmaTech could prove difficult “because these liquid products are not labeled with a PharmaTech label,” the safety alert states.
“Patients who are using liquid drug products and who have concerns should contact their health care professional,” the FDA advises. The agency recommends that pharmacies and healthcare professionals contact their suppliers to identify which of their products were made by PharmaTech, a contract development and manufacturing organization based in Florida.
“I think a key concern is that FDA knows there is a problem with PharmaTech — but they don’t quite have the list of all the companies that repackage PharmaTech products,” Erin Fox, director of drug information at University of Utah Health Care, was quoted as saying in an article published in Regulatory Affairs Professionals Society.
“This is frustrating because there is virtually no way to purchase a medication based on quality. You can watch for [Form 483s] or warning letters and try to avoid those companies, but at the end of the day if you don’t know the company that actually made the product, you can’t really know what you are buying,” she added.
The U.S. Centers for Disease Control and Prevention (CDC) warned that while Burkholderia cepacia poses few risks for healthy people, those with chronic lung diseases, as well as those with a weakened immune system, are more susceptible to infection. A major concern is that infection by Burkholderia cepacia may be difficult to treat, as the bacteria shows resistance to several antibiotics, the CDC warned.
Last year, PharmaTech recalled all of its liquid products manufactured between October 2015 and July 2016 after the Burkholderia cepacia outbreak. An FDA investigation traced the source of infection back to 10 lots of oral liquid docusate sodium manufactured by PharmaTech.