The parents of an infant who died earlier this year are pursing a wrongful death lawsuit against the makers of SimplyThick, a thickening gel sold for people with swallowing problems, which has been linked to deadly bowel problems in infants.
According to the complaint filed in Dallas County Court, Brayden Flowers fell into a coma a day after the FDA issued a warning about the risk of potentially life-threatening infant bowel problems from SimplyThick. He died two days later. The lawsuit names Thermo Pac and Medco Medical Supply as defendants.
The infant’s parents, Heather Harris and Brandon Flowers, allege that their son was prescribed SimplyThick by a neonatologist to aid him with digestion problems. They subsequently found him in his crib unresponsive. He died at the age of 17 weeks old.
SimplyThick is a thickening agent used by both children and adults. When given to infants it is added to their formula or milk to help them keep food down without spitting up. It is distributed by SimplyThick, LLC and has been on the market since 2001.
FDA officials said they were first made aware of the potential risk of bowel problems from SimplyThick after reports were submitted by doctors to the FDA’s Adverse Event Reporting System (AERS) on May 13. At least 15 infants have reportedly contracted necrotizing enterocolitis (NEC) from SimplyThick. At least two have died.
FDA officials indicate that they are unable to determine, so far, why SimplyThick side effects would cause necrotizing enterocolitis in premature infants. The condition usually affects infants very early, but those that appear to be related to SimplyThick have involved a late onset, with some not being affected until they had been released from the hospital.
Necrotizing enterocolitis is an intestinal disorder that results in inflammation and necrosis of intestinal tissues. It is usually diagnosed in premature babies and can be life-threatening. Symptoms can include a bloated abdominal area, green-tinged vomiting and blood stools.
The FDA is currently investigating the link between SimplyThick and the bowel problems for infants, and will provide updates when more information is available, according to the public health warning. In the interim, parents, doctors and care givers are urged not to give SimplyThick to premature infants. Parents or care givers who have been giving an infant SimplyThick should contact a health care professional if the baby begins to show any signs of NEC.