Probiotics are dietary supplements made up of live bacteria that are considered helpful in maintaining the body’s natural balance of gut microorganisms. They are available in powders, liquids or pills. Some neonatal intensive care units (NICUs) have used them for years based on evidence that the bacteria can help protect these fragile infants from deadly intestinal disease.
Because probiotics are dietary supplements, and not considered pharmaceutical drugs, they are not held to the same regulatory standards as prescription or even over-the-counter medications. The Food and Drug Administration (FDA) urges consumers to be cautious when using dietary supplements as some can contain undeclared, illegal or even dangerous ingredients, or their manufacturing practices may not be up to par.
Physicians at Yale-New Haven Hospital believed they chose a safe probiotic because it was made by a large, seemingly reputable company that marketed its products specifically for infants and children at retail stores across the country. When Calvin Jimmy Lee-White was born Oct. 3, 2014, two months premature weighing just 3 pounds, his doctors prescribed a probiotic, among other treatments.
Instead of getting stronger, Calvin became sicker. Doctors performed surgery and found that his intestines were covered in a rare fungus. The infection spread to his blood vessels and caused multiple blockages. When it reached his aorta, it caused a clot. Eight days after he was born, Calvin died.
FDA officials launched an investigation into the source of the fungus and found that the probiotic he was given was contaminated. Further testing on unopened containers of the same batch of probiotic given to Calvin was also contaminated.
Manufacturer Solgar ended up recalling certain batches of its ABC Dophilus Powder from pharmacies and drugstores across the country.
Calvin’s family is suing the hospital as well as Solgar, alleging the supplement caused the deadly intestinal infection that killed Calvin.
The case brings up serious concerns with dietary supplements in general. So-called “natural” substances such as vitamins, minerals, herbs and botanicals are growing in numbers on store shelves and online. And consumers are buying them.
Nutrition Business Journal reports that sales of dietary supplements have increased by 81 percent in the past decade. While some manufacturers are reputable, others are not. And even trustworthy manufacturers can still have issues that result in contamination that can make consumers sick.
Unfortunately, dietary supplements can skirt under government regulations, which means consumers have to careful when using the products. “Because of the way they’re regulated, you often have no idea what you’re actually ingesting,” warns Pieter Cohen, MD, assistant professor of medicine at Harvard Medical School and expert on dietary supplements.
Source: Consumer Reports