SimplyThick a risk to all infants, FDA cautions
A product used to help infants with difficulty swallowing could lead to a life-threatening condition, the FDA says.
September 18th, 2012
03:04 PM ET

SimplyThick a risk to all infants, FDA cautions

A product used to help infants with difficulty swallowing could increase their risk of developing a life-threatening illness, the Food and Drug Administration warned Tuesday.

The agency says 22 infants developed necrotizing enterocolitis (NEC) after being fed the thickening agent SimplyThick - reportedly as directed. Seven of them died.  Necrotizing enterocolitis is a condition where tissue in the intestines gets inflamed and dies.  It occurs most often in babies that are ill or born prematurely.  The cause is unknown.

SimplyThick is mixed with breast milk or infant formula to help babies swallow their food and keep it down without spitting it back up.  It's sold in individual packets or 64-ounce bottles that can be bought from local pharmacies or distributors across the country.

Of the 22 infants who became ill, 21 were born premature. Half of the babies developed NEC while still in the hospital and the other half at home. Fourteen of them needed surgery.  NEC symptoms include a bloated stomach, greenish-colored vomiting and bloody stools.

Last May, the FDA issued an advisory warning consumers of SimplyThick's risk to premature infants. The agency is now extending that warning to all babies because it believes parents, caregivers and doctors will benefit from the information if considering whether to give the thickener to babies of any age, says FDA spokeswoman Tamara Ward.

Parents and caregivers who have questions or concerns related to the use of the product or medical concerns should contact their doctor, Ward says.

The agency was first alerted to the problem when two reports were filed with its MedWatch Safety Information and Adverse Event Reporting Program.  Officials say more study is needed to determine if there is an actual link between NEC and SimplyThick or other thickening agents.  In the meantime, they say consumers and health care professionals need to be aware of the possible risks before using the product.

SimplyThick says consumers and doctors should follow the FDA recommendations that “anyone involved in the care of a baby be aware of potential risk before deciding whether to feed SimplyThick to infants of any age."

"If you are currently giving SimplyThick to your infant, please consult your child’s health care professional," said John Holahan, CEO of SimplyThick. "We continue to advise following FDA’s previous recommendation that SimplyThick brand thickener not be used with or given to babies who were born before 37 weeks.  We hope that this does not cause any inconvenience to medical professionals or our customers but, as you can understand, SimplyThick wants to proceed with all due caution."

The FDA says that this product is also used for older children and adults with swallowing problems.  These patients are not included in the warning.

soundoff (31 Responses)
  1. notanignoramus

    The link posted for necrotizing enterocolitis links to the National Necrotizing Fasciitis Foundation, which doesn't have any information on enterocolitis. Here is a better link:

    September 19, 2012 at 10:04 | Report abuse | Reply
  2. That's What's Up

    I feel SimplySick after reading this

    September 19, 2012 at 10:17 | Report abuse | Reply
    • jobob

      Well played, sir (or madame)

      September 19, 2012 at 15:36 | Report abuse |
  3. goodmom

    what's wrong with rice cereal???? I used it with both my babies, worked like a charm and didn't have a bunch of crap in it. 🙁 I hate this story.

    September 19, 2012 at 10:28 | Report abuse | Reply
    • Lisa

      Seriously? Rice cereal for a premature baby?

      And read up on the harms of feeding any baby, especially young babies, rice cereal. It is NOT healthful.

      September 19, 2012 at 12:48 | Report abuse |
    • Mom of 5

      Actually Rice cereal is what my childrens doctor recommended when they were infants to help with reflux and also my now 7 year old was born with malrotation of her intestions and the childrens hospital she had her corrective surgery at used rice cereal in her formula once she was allowed to start eatting again. Mind you all of my children were premature and my 7 year old was almost 2 months early.

      December 21, 2012 at 23:06 | Report abuse |
  4. Jenn

    Your link for NEC leads to the skin eating diesase not the digestive diease..

    September 19, 2012 at 11:00 | Report abuse | Reply
  5. NODAT1

    is simple thick just another tool to be used so that lazy parents and caregivers are not bothered by babys? after all we cant have babys going around making a mess, now can we!!!

    September 19, 2012 at 12:26 | Report abuse | Reply
    • Lisa

      No, that's not what it was designed for. Did you read the article? It's for premature babies who have difficulty coordinating their swallowing reflex. It's just like the stuff they use to thicken liquids for stroke victims who would otherwise choke on thin liquids.

      This is what lazy parents and caregivers use: http://ecochildsplay.com/2009/09/01/restfull-infant-formula-is-full-of-something/

      Because dealing with children more than 12 hours a day is just not convenient.

      September 19, 2012 at 12:53 | Report abuse |
    • Sarah

      You are an idiot. My son takes simply thick because he was premature and does not swallow correctly. If for some reason he does drink fluids without it, chances are that the fluids can get in his lungs and cause pneumonia and/or other sicknesses. He aspirates when drinking fluids without thickener. Parents don't feed their babies Simply thick because they are lazy, they do it because they have to. It is expensive and sometimes a pain in the ass, but I do it for the health of my child. I have been doing it for an entire year. One of these days hopefully my son will be able to drink regular fluids on his own. Your comment is dumb and offensive. Go "F" yourself.

      September 19, 2012 at 16:55 | Report abuse |
    • Star

      Umm do you have any idea at all what simply thick is used for? Some babies (like mine) are born early (mine was 1 lb 12 oz, 3 months early)and can't swallow thin liquids, or it will go down into their lungs, SOOO they thicken the liquid, giving the child a better chance of swallowing the right way. You need to be more considerate.

      September 20, 2012 at 19:32 | Report abuse |
  6. sue

    It is unfortunate that such adverse side effects may be associated with simply thick because it was helpful in thickening formula and getting nutrients into infants.

    September 19, 2012 at 12:54 | Report abuse | Reply
  7. Bersy

    This product is used widely in nursing homes. Would this have been news if it was killing the elderly instead of infants? How do we know it isn't? I see it all the time – someone in a nursing home dies and no one questions it because the person was "old".

    September 19, 2012 at 22:10 | Report abuse | Reply
    • Bart

      You got a point there, Bersy. Medications could be killing old people and who would notice, because like you said, they are old and expected to die sooner or later anyway. Something to think about, good point.

      September 20, 2012 at 03:48 | Report abuse |
  8. Bart

    What's wrong with simply corn starch? Oh yeah, it would thicken things but you couldn't charge an arm and a leg for it. It would be safe too. What was I thinking, they can't make money off of corn starch. Much better to develop something new that you can over price and get a patent on.

    September 20, 2012 at 03:43 | Report abuse | Reply
    • AGeek

      Corn (or tapioca, and most carbohydrate-based) starch requires heat, typically just under the boiling point, to thicken anything. This temperature also has a tendency to reduce the nutritional content of foods. It's also not always possible to heat formula up to 200+degF and have time to let it cool down to a temperature suitable for consumption.

      September 20, 2012 at 05:26 | Report abuse |
  9. rosethornne

    There are lots of choices of food. Why on earth would anyone choose something expensive that apparently has ingredients so bad it kills people?

    September 20, 2012 at 16:15 | Report abuse | Reply
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  11. anotherchallenge

    ok...are there any parents who are bummed because they thought they finally found help with this product, and are now back to square 1....Any thoughts or suggestions on what to use now to prevent aspiration??? I tried oatmeal, but the amount I have to use for the correct thickness amounts to about 2 1/2 cups of oatmeal a day for a 9 month old!! I don't think THAT is a good idea!!!

    October 4, 2012 at 07:20 | Report abuse | Reply
    • mom to 2

      I actually just found out about the recall recently, i had heard about the concerns with preemies before, but our child was over 2 when we had to start thickening her fluids following 2 major surgeries to rebuild her airway. I had no concerns using Simply Thick after the warnings for preemies, since she was older. It was a lifesaver. However, if you want to save money and you have a couple minutes to spare, you can make the exact same think with xanthan gum and water, that's all Simply Thick is, other than the preservative they add to it. Homemade thickener is not perfectly clear, but works just as well! A bag of xanthan gum costs around $8-10 and lasted us several months (depends on how thick you need fluids and how much the person drinks of course!) My point is- Simply Thick is still an awesome and invaluable product for convenience, for children who are not "babies" I guess. If you're not comfortable with the issues they had with preemies, try making your own with xanthan gum!! It's great!

      November 7, 2012 at 15:01 | Report abuse |
    • mom to 2

      I should clarify also, I'm not sure at what age they consider it safe to use Simply Thick- I don't know if a 9mo old is old enough to use it without concerns or not? Also, if you search information online or speak to the company directly, I think the issue was one of contamination, and they have since changed procedures/verification of sterility, and are replacing any old packets sold before the changes were put in place. I used them since I didn't hear about it until recently, and we never had a single problem. Good luck!

      November 7, 2012 at 15:04 | Report abuse |
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  13. carol

    As the article says, people use SimplyThick for their babies because they have trouble swallowing, it has nothing to do with laziness. I feel terrible for the families whose children got sick or died because they were following their doctors instructions and trying to prevent another life-threatening complication. I'm not surprised that some of them are filing lawsuits.

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