Dietary supplements are not regulated the same way as medications. This lack of oversight puts consumers' health at risk.
By Jeneen Interlandi
Calvin Jimmy Lee-White was tiny. He was
born on Oct. 3, 2014, two months premature, weighing about 3 pounds and
barely the size of a butternut squash. There are standards of care for
treating infants that fragile, and as an attorney for the baby’s family later acknowledged, doctors
at Yale-New Haven Hospital in Connecticut followed them. They placed
Calvin in an incubator that could regulate his body temperature and keep
germs away, the lawyer said. And they administered surfactant drugs,
which help promote crucial lung development in premature infants. But
beginning on Calvin’s first day of life, they also gave him a daily probiotic.
Probiotics are powders, liquids, or pills made up of live bacteria thought to help maintain the body’s natural balance of gut microorganisms. Some neonatal intensive care units (NICUs) have been giving them to preemies in recent years based on evidence that they can help ward off deadly intestinal disease.
Some doctors are concerned about that trend. Because probiotics can be classified as dietary supplements, they don’t have to be held to the same regulatory standards as prescription or even over-the-counter drugs. Manufacturers don’t have to secure Food and Drug Administration approval to sell their products, and their facilities aren’t policed the same way as pharmaceutical companies.
But the NICU at Yale-New Haven chose what looked to be a safe product. It was made by a large, seemingly reputable company, marketed specifically for infants and children, and available at drugstores across the country.
Calvin struggled anyway. His abdomen developed bulges, and surgery revealed that his intestines were overrun by a rare fungus. The infection spread quickly from his gut to his blood vessels, where it caused multiple blockages, and then into his aorta, where it caused a clot.
On Oct. 11, at just 8 days old, baby Calvin died. Government officials then launched a mournful investigation. Where did the fungus come from? And how did it get into this premature baby’s tiny body? Consumer Reports
Probiotics are powders, liquids, or pills made up of live bacteria thought to help maintain the body’s natural balance of gut microorganisms. Some neonatal intensive care units (NICUs) have been giving them to preemies in recent years based on evidence that they can help ward off deadly intestinal disease.
Some doctors are concerned about that trend. Because probiotics can be classified as dietary supplements, they don’t have to be held to the same regulatory standards as prescription or even over-the-counter drugs. Manufacturers don’t have to secure Food and Drug Administration approval to sell their products, and their facilities aren’t policed the same way as pharmaceutical companies.
But the NICU at Yale-New Haven chose what looked to be a safe product. It was made by a large, seemingly reputable company, marketed specifically for infants and children, and available at drugstores across the country.
Calvin struggled anyway. His abdomen developed bulges, and surgery revealed that his intestines were overrun by a rare fungus. The infection spread quickly from his gut to his blood vessels, where it caused multiple blockages, and then into his aorta, where it caused a clot.
On Oct. 11, at just 8 days old, baby Calvin died. Government officials then launched a mournful investigation. Where did the fungus come from? And how did it get into this premature baby’s tiny body? Consumer Reports
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