Saturday, October 27, 2012

FDA "SimplyThick" Infant Health Risk Warnings are Complicated

SimplyThick®— SimplyThick The Thickening Gel You Can't Taste®

SimplyThick®, a food and beverage additive, is under FDA investigation as a possible causative, necrotizing enterocolitis, factor in the death of seven pre/post term infants. Product recall is difficult because SimplyThick, a nationwide non-prescription product, is marketed as an aid for those who suffer swallowing disorders (dysphagia).

Health Canada strengthened SimplyThick infant risk warnings on October 18, 2012.

There are no preclinical/clinical trial studies to suggest that SimplyThick, a xanthan gum-based, likely-imported Chinese manufactured product, was suitable or safe for Neonatal Intensive Care Unit patients. The company Web site states that:
SimplyThick® is the next-generation food and beverage thickener designed specifically for people who have difficulties swallowing.
Burdock Group 2001 Risk Assessment Opinion re Phagia-Gel Technologies SimplyThick Product

In spite of limited adult clinical trial xanthan gum research, George A. Burdock, Ph.D and Ioana G. Carabin, M.D. favorably determined for Phagia-Gel Technologies principals, John Holahan and Matt Knehans that:
Therefore, allowing the addition xanthan gum to foods for infants and children (200g/(7oz.) day for a 10-kg/(22-pound child) indicates safety for consumption and lack of concern for induction or worsening of dehydration, even at very high levels of xanthan gum. A warning on the Phagia Gel Technologies SimplyThick (TM) product is not necessary, as the warning only applies to over-the-counter drug products (FR, August 26, 1993).
Neonatal Intensive Care: SimplyThick Commonly Prescribed

It is a matter of concern that a number of North Carolina and other states' Neonatal Intensive Care facilities prescribed SimplyThick ® because various 1984-2003 studies indicate that "Thickening milk feeds may cause necrotising enterocolitis." —P Clarke, M J Robinson Neonatal Intensive Care Unit, Hope Hospital, Salford, UK, M6

Clarke & Robinson are of the opinion that formula thickeners do not reduce the incidence of gastro-esophageal reflux. They further state that thickening agents "may not be free from serious adverse effects and should not become widely adopted without a randomised trial."

The FDA stated that the agency first became aware of the SimplyThick ® link to infant NEC in December 2010. It is yet to be determined, but as noted in the following reports the 2001 Burdock Group approved SimplyThick product may have been responsible for previous NEC occurrences.

Cluster of necrotizing enterocolitis in a neonatal intensive care unit: New Mexico, 2007American Journal for Infection Control

In 2007, a New Mexico hospital experienced a necrotizing enterocolitis neonatal intensive care unit event. A six-week study January 1, 2007- February 13, 2007 conducted by the American Journal for Infection Control found eleven NEC cases, etiology undetermined. Researchers concluded that "enhanced infection control and changing batches of HMF (human milk fortifier) might have played a role in controlling this outbreak."

The case study: "Development of necrotizing enterocolitis in premature infants receiving thickened feeds using SimplyThick" was submitted to the Journal of Perinatology in May 2011. The authors, all associated with the Brenner Children's Hospital in Winston-Salem, NC stated that:
We recently began using ST(Simply Thick) to treat premature infants with dysphagia and or gastroesophageal reflux. We describe three cases of premature infants who developed necrotizing enterocolitis (NEC) after they were fed ST. Unlike classic NEC, all three cases presented with late-onset colonic NEC.
The case study: "Late Onset Necrotizing Enterocolitis in Infants following Use of a Xanthan Gum-Containing Thickening Agent" was submitted to the Journal of Pediatrics in January 2012.

Adverse event reports submitted to the US Food and Drug Administration suggested a possible association between necrotizing enterocolitis and ingestion of a commercial feed thickener by premature infants. Review in 2011 of 22 cases with exposure revealed a distinct illness pattern.
"NEC with Thickened Formula" — August 2012
Journal of Pediatrics —Volume 161 Page A 4
Alan H. Jobe, MD, PhD
Neonatologists seem determined to treat the poorly defined reflux that frequently occurs in preterm infants with something—preferably drugs that are off-label and have no proven efficacy. Popular choices are prokinetic agents and proton pump inhibitors. Another unvalidated strategy is to thicken feeds. In this issue of The Journal, Beal et al report a series of 22 cases of necrotizing enterocolitis NEC that were associated with a commercial xanthan gum-containing food thickener. These cases of NEC are quite unique in the time of onset of the disease after birth. Most of the 22 infants were preterm, but the onset of NEC was at a mean of about 40 weeks gestational age, with a number of infants developing NEC at home after discharge—a most unusual timing for the onset of NEC. Although this case series does not prove cause and effect, the disease presentation strongly implicates this food thickener as a risk for NEC. Perhaps clinicians should restrain their enthusiasm for other thickeners for the feeding of preterm infants as well. The proven treatments for reflux in otherwise normal preterm infants are time and patience.

WebMD September 2012: "FDA to Parents: Don't Give SimplyThick to Infants" extract:
This warning is specific to SimplyThick and does not include other thickening products, says FDA spokeswoman Tamara N. Ward. "Parents and caregivers who have questions or concerns related to the use of the product and/or who have medical concerns should contact their health care provider.”

SimplyThick and other thickeners are not meant for infants, period, says Jesse Reeves-Garcia, MD. He is the director of gastroenterology at Miami Children's Hospital. “Infants are not meant to be eating solid foods, so these products are not appropriate.”
Beasley Firm, LLC:
After issuing the original warning, the FDA continued to conduct extensive reviews of reports potentially linked to the use of SimplyThick. It was noted that approximately 24 full term infants developed NEC after being administered SimplyThick in addition to 21 premature babies.
CourtHouse News report: Jack Mahoney died of NEC following a prescribed SimplyThick feeding regime. Date of incidence — April 2011, location —Wake Medical Hospital, Raleigh, NC

Devon Addonizio has filed a SimplyThick et al lawsuit on behalf of her NEC-injured daughter. Date of incidence — May 2010, location —New York City.

Shane and Jennifer Umphress have filed a SimplyThick et al lawsuit on behalf of their NEC-injured daughter. Date of incidence —September 2009, location—University of New Mexico Hospital Las Cruces, New Mexico.
University of New Mexico Children's Hospital NICU 2011-2012 Orientation Manual page 17 — SimplyThick is classified as a "dietary snack."

Pamela Konkle notified the press and the FDA in September 2011 that her daughter Hannah was diagnosed with NEC shortly after being prescribed SimplyThick.
Date of incidence— January 2010, location — Riley Children's Hospital, Muncie, IN.

Brayden Harris was born on January 27, 2011 and died of SimplyThick induced necrotizing enterocolitis on May 26, 2011 according to a lawsuit filed by his parents. Case will be adjudicated in Dallas.

Mackenna Cope died of NEC. Her mother, Stacy, was notified in May 2011 that her daughter's death was possibly related to the NICU's use of SimplyThick. Date of incidence — May 2009, Location —Memorial Hospital Colorado Springs, Co. Memorial Hospital reported four other SimplyThick-NEC cases to the FDA.

One of the most relevant NEC cases involve Florida twins, Jaden and Genesis Santos, who were under Florida Hospital Neonatal care in 2011. Shortly after discharge and on a medically prescribed SimplyThick feeding regime, Jaden Santos died of necrolizing enterocolitis on April 8, 2011.

Parents of NEC-damaged infants are seeking redress as a result of the FDA SimplyThick ® warning. Primary parties under scrutiny: SimplyThick, LLC, Phagia-Gel Techologies LLC, owner of SimplyThick— Thermo Pac, LLC manufacturing contractor for SimplyThick, — AmeriQual Group, owner of Thermo Pac and H. J. Heinz the former owner of Thermo Pac.

Thermo Pac, LLC Deficiencies

Following the FDA 5/23/2011- 6/3/2011 inspection of the Thermo Pac Stone Mountain, Ga facility, SimplyThick and the FDA jointly decided to recall SimplyThick ( June 1, 2009- June 3, 2011 ) products. During the course of investigation the FDA found evidence of bacillus cereus in eleven SimplyThick finished products and one xanthan-gum raw sample. On June 29, 2011, SimplyThick notified the FDA that the company would resume sales, as its product no longer posed a public health risk.

FDA SimplyThick Infant Health Risk Communications

May 20, 2011 FDA SimplyThick Premature Infant Health Risk Advisory
Illnesses have been reported from at least four different medical centers around the country. The illnesses of which FDA is aware involve premature infants who became sick over the past six months. SimplyThick was added to the feeding regimen of those infants who later developed NEC to help with swallowing difficulties stemming from complications of premature birth. The thickening product may cause necrotizing enterocolitis (NEC), a life-threatening condition.

FDA first learned of adverse events possibly linked to the product on May 13, 2011. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers’ breast milk or infant formula products.
September 18, 2012 FDA SimplyThick Infant Health Risk Warning
Since May 2011, the agency has identified 22 infants who developed necrotizing enterocolitis (NEC), a condition in which tissue in the intestines becomes inflamed and dies, after being fed SimplyThick. Seven of those infants died. Infants of any age may face an increased risk of developing a life-threatening condition if fed a thickening product called SimplyThick.

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