FDA Alert: Necrotizing Enterocolitis in Premature Infants Exposed to a Thickening Agent

FDA Alert: Necrotizing Enterocolitis in Premature Infants Exposed to a Thickening Agent

Brief Summary of Report:

FDA is advising health-care providers and consumers to refrain from using the thickening agent SimplyThick in premature infants. Two possibly related deaths have been reported.

This U.S. Food and Drug Administration (FDA) alert warns of a life-threatening bowel condition in premature infants that has been associated with eating SimplyThick, a thickening agent. This information is intended for public health officials, emergency medicine practitioners, pediatric health-care providers, and consumers. ISSUE:FDA notified parents, care givers, and health-care providers not to feed SimplyThick, a thickening agent for management of swallowing disorders, to infants born before 37 weeks. This 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. As of May 20, 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 care givers who have questions or concerns related to the use of the product or who have medical concerns should contact their health-care provider. Please see the photographs at the link below for images of the product. Please read the MedWatch safety alert, including links to the Press Release and product photos, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm256257.htm FDA is requesting that public health partners report cases of necrotizing enterocolitis in infants consuming SimplyThick to emergency.operations@fda.hhs.gov.

WV Flu Activity Week 19

West Virginia has reported influenza activity as “No Activity” for MMWR week 19 ending Saturday, May 14, 2011.

There were no positive tests for influenza A and no positive tests for influenza B reported by hospital and referral laboratories. Only PCR, immunofluorescence and culture results are counted in these totals.

At the Office of Laboratory Services there were no positive tests for influenza A:  H1N1 or H3.  There were no positive tests for influenza B.

There were no outbreaks of confirmed influenza activity in nursing homes or schools.

Up to date information can be found at the website:

http://www.wvidep.org/tabid/1960/Default.aspx

CDC Synopsis:

During week 19 (May 8-14, 2011), influenza activity in the United States continued to decrease.

• The proportion of deaths attributed to pneumonia and influenza (P&I) was below the epidemic threshold.
• Three influenza-associated pediatric deaths were reported, bringing the season total to 105. One of these deaths was associated with a 2009 influenza A (H1N1) virus, one was associated with an influenza A (H3) virus, and one was associated with an influenza A virus for which the subtype was not determined.
• The geographic spread of influenza in Puerto Rico and 27 states was reported as sporadic, and the District of Columbia, the U.S. Virgin Islands, Guam, and 23 states reported no influenza activity.

No. of specimens tested	1,265
No. of positive specimens (%)	14 (1.1%)
Positive specimens by type/subtype
Influenza A	8 (57.1%)
A (2009 H1N1)	1 (12.5%)
A (subtyping not performed)	2 (25.0%)
A (H3)	5 (62.5%)
Influenza B	6 (42.9%)

WV Flu Avtivity Week 18

West Virginia has reported influenza activity as “No Activity” for MMWR week 18 ending Saturday, May 7, 2011. 

There were no positive tests for influenza A and no positive tests for influenza B reported by hospital and referral laboratories. Only PCR, immunofluorescence and culture results are counted in these totals.

At the Office of Laboratory Services there were no positive tests for influenza A:  H1N1 or H3.  There were no positive tests for influenza B.

There were no outbreaks of confirmed influenza activity in nursing homes or schools.

Up to date information can be found at the website:

http://www.wvidep.org/tabid/1960/Default.aspx

CDC Synopsis:

During week 18 (May 1-7, 2011), influenza activity in the United States continued to decrease.

• The proportion of deaths attributed to pneumonia and influenza (P&I) was at the epidemic threshold.
• Two influenza-associated pediatric deaths were reported, bringing the season total to 102. One of these deaths was associated with a 2009 influenza A (H1N1) virus and one was associated with an influenza A virus for which the subtype was not determined.
• The geographic spread of influenza in one state was reported as regional; two states reported local influenza activity; Puerto Rico, the District of Columbia, and 33 states reported sporadic influenza activity; and the U.S. Virgin Islands, Guam, and 14 states reported no influenza activity.

No. of specimens tested	1,567
No. of positive specimens (%)	29 (1.9%)
Positive specimens by type/subtype
Influenza A	20 (69.0%)
A (2009 H1N1)	2 (10.0%)
A (subtyping not performed)	9 (45.0%)
A (H3)	9 (45.0%)
Influenza B	9 (31.0%

Week 17 WV Flu Activity Sporadic

West Virginia has reported influenza activity as “Sporadic” for MMWR week 17 ending Saturday, April 30, 2011. 

There was 1 positive test for influenza A and 2 positive test for influenza B reported by hospital and referral laboratories. Only PCR, immunofluorescence and culture results are counted in these totals.

At the Office of Laboratory Services there were 2 positive tests for influenza A, 0% (0) were influenza A 2009 (H1N1) and 100% (2) were positive for influenza A, H3.  There were no positive tests for influenza B.

There were no confirmed outbreaks of influenza in nursing homes or schools.

Up to date information can be found at the website:

http://www.wvidep.org/tabid/1960/Default.aspx

CDC Synopsis:

During week 17 (April 24-30, 2011), influenza activity in the United States continued to decrease.

• The proportion of deaths attributed to pneumonia and influenza (P&I) was below the epidemic threshold.
• Three influenza-associated pediatric deaths were reported, bringing the season total to 100. One of these deaths was associated with a 2009 influenza A (H1N1) virus, one was associated with an influenza A virus for which the subtype was not determined, and one was associated with an influenza B virus.
• The geographic spread of influenza in two states was reported as regional; the District of Columbia and seven states reported local influenza activity; Puerto Rico and 33 states reported sporadic influenza activity, and the U.S. Virgin Islands, Guam, and eight states reported no influenza activity.

No. of specimens tested	1,901
No. of positive specimens (%)	69 (3.6%)
Positive specimens by type/subtype
Influenza A	36 (52.2%)
A (2009 H1N1)	6 (16.7%)
A (subtyping not performed)	11 (30.6%)
A (H3)	19 (52.8%)
Influenza B	33 (47.8%)

Week 16 WV shows no Flu Activity

West Virginia has reported influenza activity as “No Activity” for MMWR week 16 ending Saturday, April 23, 2011.

There were 0 positive tests for influenza A and 1 positive test for influenza B reported by hospital and referral laboratories. Only PCR, immunofluorescence and culture results are counted in these totals.

At the Office of Laboratory Services there were no positive tests for influenza A and there were no positive tests for influenza B.

There were no outbreaks of confirmed influenza activity in nursing homes or schools.

Up to date information can be found at the website:

http://www.wvidep.org/tabid/1960/Default.aspx

CDC Synopsis:

During week 16 (April 17-23, 2011), influenza activity in the United States continued to decrease.

• The proportion of deaths attributed to pneumonia and influenza (P&I) has been at or above the epidemic threshold for 13 consecutive weeks.
• Two influenza-associated pediatric deaths were reported, bringing the season total to 97. Both of these deaths were associated with an influenza B virus.
• The geographic spread of influenza in four states was reported as regional; the District of Columbia and 10 states reported local influenza activity; Puerto Rico and 32 states reported sporadic influenza activity, and the U.S. Virgin Islands, Guam, and four states reported no influenza activity.

No. of specimens tested	2,072
No. of positive specimens (%)	88 (4.3%)
Positive specimens by type/subtype
Influenza A	50 (56.8%)
A (2009 H1N1)	5 (10.0%)
A (subtyping not performed)	13 (26.0%)
A (H3)	32 (64.0%)
Influenza B	38 (43.2%)