Call Today for a FREE Confidential Case Review
Toll-Free 24/7 (866) 920-0753

Probiotic Supplements May have Fungal Infection Risk

Probiotic Supplements May have Fungal Infection Risk

December 12, 2014 — The FDA is warning doctors to think twice before using probiotic supplements to treat diseases in immunocompromised patients.

One month ago, a premature infant died after it was given ABC Dophilus, which is a powder that is formulated to contain three species of live bacteria.

The infant developed a gastrointestinal fungal infection known as mucormycosis. The infection was caused by the mold Rhizopus oryzae, which was also discovered in an unopened container of ABC Dophilus.

The manufacturer, Solgar Inc., issued a recall on November 17.

The FDA cautions that supplements are not generally regulated as drugs, even if they contain live bacteria or yeast:

“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.”

Several peer-reviewed studies have recommended probiotics to prevent necrotizing enterocolitis in premature infants. An FDA review of the medical literature found these studies lacked adequate documentation of the safety risks.

The FDA asks doctors to use caution when administering supplements in immunocompromised patients. They have also asked doctors to submit an Investigational New Drug Application (IND) when they use probiotics to treat or prevent diseases.

Do I have an ABC Dophilus Lawsuit?

The Schmidt Firm, PLLC is currently accepting ABC Dophilus induced injury cases in all 50 states. If you or somebody you know has been diagnosed with mucormycosis or another infection, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Dietary Supplement Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.

Free Case Evaluation

The Schmidt Firm, PLLC has been recognized as one of the nation’s leading plaintiffs' law firms and handles cases in all 50 states. We are very proud of our legal achievements, but equally self-respecting of our firm's reputation for providing personal attention to each and every client we represent.

No matter what type of case you have, you may contact us with confidence by filling out the email contact form below or calling us directly by dialing toll free 24 hrs/day (866) 920-0753.