FDA Warns about Probiotics after Death of Infant, Parker Waichman LLP Comments

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The U.S. Food and Drug Administration (FDA) has warned about the risks of dietary supplements containing live bacteria or yeast being taken by patients with compromised immune systems. The warning was issued after an infant tragically died of an invasive fungal disease following treatment with ABC Dophilus.

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“We want to spread awareness about the new FDA warning in the hopes of preventing future tragedies such as this,” said Gary Falkowitz, Managing Attorney at Parker Waichman LLP.

Parker Waichman LLP (http://www.yourlawyer.com), a national law firm dedicated to protecting the rights of victims injured by defective drugs, is commenting on a recent FDA warning concerning probiotics and dietary supplements. On December 17, 2014 Forbes reported that the federal regulator warning was prompted by the pre-term death of an infant who developed mucormycosis, an invasive fungal disease of the gastrointestinal tract, after being given the supposed probiotic supplement ABC Dophilus. The dietary supplement is manufactured by Solgar Inc. of Leonia, New Jersey. The product claims to “support good health in these populations by helping to maintain a healthy balance within the intestine’s microbial ecology” using three bacterial strains, according to Forbes. Investigators from the U.S. Centers for Disease Control and Prevention (CDC) discovered the fungus, Rhizopus oryzae, in unopened bottles of the product.

On December 9, 2014, the FDA, issued an “Important Drug Warning Regarding Use of Dietary Supplements in Immunocompromised Persons,” in which the federal regulators emphasized that dietary supplements are not regulated as approved drugs. The warning states, “As such, these products are not subject to FDA’s premarket review or approval requirements for safety and effectiveness, nor to the agency’s rigorous manufacturing and testing standards for drugs, including testing for extraneous organisms.”

Also according to Forbes, Solgar recalled three lots of ABC Dophilus on November 17, 2014. As of November 24, 2014, the CDC case summary indicates that the product “should not be used”.

“We want to spread awareness about the new FDA warning in the hopes of preventing future tragedies such as this,” said Gary Falkowitz, Managing Attorney at Parker Waichman LLP. “Our firm continues to offer free legal consultations to anyone with questions about injuries allegedly resulting from drugs, as well as dietary supplements.”

Parker Waichman LLP offers free lawsuit consultations to victims of drug injuries and side effects. For more information concerning probiotic side effects, please visit the firm’s Defective Drug Page. Free case evaluations are also available by calling 1-800-LAW-INFO.

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