ISSUE: FDA notified parents, caregivers and health care providers not to feed SimplyThick, a thickening agent for management of swallowing disorders, to infants born before 37 weeks. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition characterized by inflammation and death of intestinal tissue.
BACKGROUND: 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. Illnesses have been reported from at least four different medical centers around the country. The illnesses of which FDA is aware involve premature infants. 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 product is sold in packets of individual servings and in 64-ounce dispenser bottles. The product can be purchased from distributors and local pharmacies throughout the United States.
RECOMMENDATION: Health care providers should stop administering the product to premature infants. 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. See the photographs at the link below for images of the product.
Read the MedWatch safety alert, including links to the Press Release and product photos, at:
Tags: MedWatch Alert, SimplyThick
Pregnant women – like the rest of us – have a choice to make. Do we wait for the hundreds of randomized controlled trials that are currently being conducted to see if vitamin D helps, or do we act now, on what we know now?
Today, pregnant women – and the rest of us – learned that pregnant women with the lowest vitamin D levels had infants that were six times more likely to get the most common cause of viral pneumonia over the first year of their life.
As I write this, the paper is not yet indexed in PubMed but I found some evidence it was rushed to publication (percentages of women using vitamin D supplements in the next to last row of Table 1 on page 1516 are reversed). However, what I liked was the authors intimation that current recommendations of 600 IU/day for pregnant women by the National Academies (the Food and Nutrition Board) are woefully inadequate. A number of studies exist showing vitamin D deficiency is a risk factor for infantile pneumonia, but this was a prospective study of vitamin D levels, a type of study that is as close to a randomized controlled trial as you can get, while we wait.
The National Academies says that 600 IU/day is all pregnant women need and that 5,000 IU/day is dangerous. However, vitamin D scientists take an average of 5,000 IU/day.
Mittelstaedt M Scientists taking vitamin D in droves Jul. 22, 2010
We all have a choice to make, while we wait.
John Cannell, MD
Tags: vitamin D
The May 2011 ezine edition of The Health Gazette will be published as scheduled today.
This month we have Part 8 in our series on The Dimensions of Health. Part 8 deals with physical fitness.
Last month Dr Jenny Tylee provided a brief article titled Ginkgo Biloba: Functions and Uses. We also covered Part 7 in our series on The Dimensions of Health. Although the April edition was published on time, as scheduled, we omitted to make notice of it here — sorry about that! (We were too distracted by our vacation to beautiful Hawaii.)
Tags: dimensions of health, Health Gazette Ezine, physical fitness
The March 2011 ezine edition of The Health Gazette will be published as scheduled today.
This month Dr Jenny Tylee has a brief article titled Do You Have a Problem with Your Posture?. We also have Part 6 in our series on The Dimensions of Health.
Tags: good posture, Health Gazette Ezine
The February 2011 ezine edition of The Health Gazette will be published as scheduled tomorrow.
This month Dr Jenny Tylee has a brief article titled Lip Balm – Make it Yourself. We also have Part 5 in our series on The Dimensions of Health.