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FDA Warnings on SimplyThick Too Late for Some Parents Whose Infants Developed Necrotizing Enterocolitis (NEC)

Feb 7, 2013

Last year, the Food and Drug Administration issued a warning that infants should not be fed SimplyThick but for some parents, the warning was already too late.

There have been at least seven reports of infant deaths that can be attributed to the ingestion of SimplyThick. SimplyThick is an additive food product that is designed for people who have trouble swallowing. Adults regularly use SimplyThick, manufactured by the company with the same name, if they have difficulty swallowing as it allows them to breathe easier.

According to a New York Times report this week on its Well/Healthy Consumer blog, some parents who lost an infant believe the company responsible for processing SimplyThick along with federal regulators, are at least somewhat liable for the death of their baby.

SimplyThick is essentially xanthan gum and the FDA considers it a safe food product but as some have learned, the agency never tested its safety on newborns. It never had to until neonatal physicians began checking with speech pathologists.

At some point recently, physicians began consulting speech pathologists, not doctors, to determine if infants - including premature babies - had swallowing trouble. If they were determined to have such a problem, a doctor would prescribe SimplyThick be added to breast milk to aid swallowing.

As this became more accepted practice, more infants began developing necrotizing enterocolitis (NEC) and some even lost their life to the condition. Based on FDA data published last year in The Journal of Pediatrics, at least 84 cases of NEC were documented among children who had been given SimplyThick. At least 22 of the cases could be linked directly to the ingestion of SimplyThick. Fourteen of those infants required emergency surgery and seven infants died as a result of the condition.

The link between the infant deaths and SimplyThick has baffled the FDA somewhat. In 2011, the agency issued a warning that premature infants should not be given SimplyThick under any circumstances. As problems persisted, regulators updated their warning to include all newborns being excluded from taking SimplyThick.

Still, the agency isn’t sure if it’s SimplyThick, xanthan gum, or the flawed manufacturing process that prompted a warning from the FDA last year to a Georgia processing facility owned by the company because some of its batches of the additive were contaminated. Some experts interviewed by New York Times for its report believe that a newborn’s digestive system may not be able to process xanthan gum and that could be leading to NEC.

Last year, the Food and Drug Administration issued a warning that infants should not be fed SimplyThick but for some parents, the warning was already too late.

 

There have been at least seven reports of infant deaths that can be attributed to the ingestion of SimplyThick. SimplyThick is an additive food product that is designed for people who have trouble swallowing. Adults regularly use SimplyThick, manufactured by the company with the same name, if they have difficulty swallowing as it allows them to breathe easier.

 

According to a New York Times report this week on its Well/Healthy Consumer blog, some parents who lost an infant believe the company responsible for processing SimplyThick along with federal regulators, are at least somewhat liable for the death of their baby.

 

SimplyThick is essentially xanthan gum and the FDA considers it a safe food product but as some have learned, the agency never tested its safety on newborns. It never had to until neonatal physicians began checking with speech pathologists.

 

At some point recently, physicians began consulting speech pathologists, not doctors, to determine if infants - including premature babies - had swallowing trouble. If they were determined to have such a problem, a doctor would prescribe SimplyThick be added to breast milk to aid swallowing.

 

As this became more accepted practice, more infants began developing necrotizing enterocolitis (NEC) and some even lost their life to the condition. Based on FDA data published last year in The Journal of Pediatrics, at least 84 cases of NEC were documented among children who had been given SimplyThick. At least 22 of the cases could be linked directly to the ingestion of SimplyThick. Fourteen of those infants required emergency surgery and seven infants died as a result of the condition.

 

The link between the infant deaths and SimplyThick has baffled the FDA somewhat. In 2011, the agency issued a warning that premature infants should not be given SimplyThick under any circumstances. As problems persisted, regulators updated their warning to include all newborns being excluded from taking SimplyThick.

 

Still, the agency isn’t sure if it’s SimplyThick, xanthan gum, or the flawed manufacturing process that prompted a warning from the FDA last year to a Georgia processing facility owned by the company because some of its batches of the additive were contaminated. Some experts interviewed by New York Times for its report believe that a newborn’s digestive system may not be able to process xanthan gum and that could be leading to NEC.


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