FDA Warns Simply Thick not safe for newborns born before 37 weeks.

FDA warns that SimplyThick could cause NEC (necrotizing enterocolitis) in infants born before 37 weeks in the womb. NEC can be a terminal condition in premature newborns, and all parents, caregivers and medical professionals should be aware.  

On May 13, 201, the FDA learned of two incidents of NEC related to SimplyThick. So far, 15 cases total have been identified, and two of these were deaths. SimplyThick was mixed with mothers’ breast milk or infant formula, and fed to newborns at various times. Four different medical centers around the country have reported these types of illnesses.  These children were given SimplyThick to help with difficulty swallowing caused by complications associated with their pre-mature 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.

FDA Recommends: 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.

Latest News from Pharma-Watch

FDA convenes to determine Fosamax bone fracture dangers

The New York Times Reports: In light of evidence linking the long-term use of Fosamax and femur fractures, the FDA said it plans to convene Friday to determine whether it will recommend suspending the use of the osteoporosis drug.

Spine Specialists Discredit Medtronic Bone Growth Product

June 29th, 2011 “It harms patients to have biased and corrupted research published…It harms patients to have unaccountable special interests permeate medical research,” read an excerpt from an

CT Brain Perfusion Scan Risks

The FDA released an advisory to consumers in October regarding the CT Bran Profusion Scan manufactured by GE. The advisory states that the scans default radiation therapy is set to high for most patient

Risk of death found in sleeping pill use -- Scripps

Scripps Study: Sleeping pills believed a cause of 500,000 premature deaths annually (March 1, 2012) Pick 10 people at random and ask them if they take sleeping pills. Chances are at least one of them

FDA pulls approval of Avastin breast cancer drug

Avastin no longer allowed for breast cancer The U.S. Food & Drug Administration has revoked its approval of Avastin after concluding the metastatic breast cancer treatment did nothing to control tumor