Wednesday, February 6th, 2013
The Food and Drug Administration has issued a warning against a common thickener used to help premature babies better consume and digest their food. The warning states that SimplyThick has a risk of causing necrotizing enterocolitis, or NEC, a life-threatening condition that damages intestinal tissue. More from The New York Times:
An F.D.A. investigation of 84 cases, published in The Journal of Pediatrics in 2012, found a “distinct illness pattern” in 22 instances that suggested a possible link between SimplyThick and NEC. Seven deaths were cited; 14 infants required surgery.
Last September, after more adverse events were reported, the F.D.A. warned that the thickener should not be given to any infants. But the fact that SimplyThick was widely used at all in neonatal intensive care units has spawned a spate of lawsuits and raised questions about regulatory oversight of food additives for infants.
SimplyThick is made from xanthan gum, a widely-used food additive on the F.D.A.’s list of substances “generally recognized as safe.” SimplyThick is classified as a food and the F.D.A. did not assess it for safety.
John Holahan, president of SimplyThick, which is based in St. Louis, acknowledged that the company marketed the product to speech language pathologists who in turn recommended it to infants. The patent touted its effectiveness in breast milk.
However, Mr. Holahan said, “There was no need to conduct studies, as the use of thickeners overall was already well established. In addition, the safety of xanthan gum was already well established.”
Image: Infant holding a bottle, via Shutterstock
Add a Comment
Tuesday, October 23rd, 2012
New research is casting new light on the efficacy of progesterone injections or suppositories in preventing early labor. The New York Times reports:
Now a new randomized double-blinded trial, published online in The American Journal of Obstetrics & Gynecology, reports that progesterone in its injected form does not work for a much larger risk group: the 10 percent of women with a cervix shorter than 30 millimeters. These women have about the same risk of having a preterm birth — around 25 percent — as those who have already had one.
“The study emphasizes that because progesterone works for one group at risk for preterm birth doesn’t mean that it can automatically be extended to others,” said the lead author of the study, Dr. William A. Grobman, a professor of obstetrics and gynecology at Northwestern.
Researchers randomly assigned 657 women to a weekly injection of a form of progesterone or to a placebo shot. All were pregnant for the first time with a single baby, and each had a cervical length of less than 30 millimeters at 16 to 22 weeks’ gestation. The women were followed through discharge from the hospital.
The scientists were unable to find any significant differences in birth outcomes between the two groups. Of those who took the progesterone, 25.1 percent delivered prematurely (at less than 37 weeks) and so did 24.2 percent of those on the placebo.
Image: Pregnant belly, via Shutterstock
Add a Comment
Tuesday, September 4th, 2012
A new study suggests that pregnant women who drink sweet sodas regularly may be more likely to deliver their babies too early, Reuters reports.
Researchers studied more than 60,000 pregnant women in Norway and found that those who drank one sugar-sweetened soda a day were up to 25 percent more likely to give birth prematurely than those who avoided sugary drinks. And pregnant women who drank artificially sweetened sodas daily were 11 percent more likely to give birth prematurely than those who skipped sweet drinks. But it’s not clear if sodas themselves deserve the blame.
[T]he new findings, published in the American Journal of Clinical Nutrition, cannot prove that sugary drinks cause preterm births. Lifestyle and other factors that go along with high sugar consumption may also play a role. Nutrition, maternal age, smoking, alcohol, obesity, chronic health problems like diabetes, and genetic conditions, have all been implicated in preterm birth.
The authors note in their report that women who drank the most sweetened drinks were also more likely to smoke, eat more calories, and have a higher body mass index (BMI) – a measure of weight relative to height – than those who drank fewer sugary drinks.
The researchers said they aren’t ready to recommend that pregnant women give up all sweetened soft drinks, but they do recommend that moms-to-be watch their sugar intake and eat more fruits and vegetables.
Image: Soft drink via Shutterstock.
Add a Comment
Monday, August 27th, 2012
Actors Anna Faris and Chris Pratt have welcomed a baby boy, People.com reports.
Faris, 35, and “Parks and Recreation” star Pratt, 33, named their son Jack. The baby was born prematurely; Faris had been due this fall.
“He arrived earlier than expected and will be spending some time in the NICU. The happy parents thank you for your warm wishes and ask that you honor their privacy during this time,” their rep told People.com.
Faris, who recently starred in the film “The Dictator,” wed Pratt in 2009.
Image: Chris Pratt and Anna Faris via s_bukley / Shutterstock.
Add a Comment
Tuesday, August 7th, 2012
CNN.com is reporting on the inspiring story of a newborn baby whose life-threatening intestinal obstruction was corrected not through major, invasive surgery, but through an innovative technique using magnets:
A thin, hard membrane was blocking a section of [newborn, 4-pound] Patrick’s intestines — the result of a rare birth defect called rectal atresia that occurs in one out of every 5,000 babies.
“We need to remove it,” the doctor told the couple.
[Dr. Eric] Scaife described to Patrick’s worried parents a long, technically difficult surgery. Patrick would be cut open through his abdomen and vertically along his tailbone. Once inside, Scaife would remove the membrane and then piece together two sections of intestines.
He had his concerns. It was a big operation on a little baby. The surgery might cause scarring, or it might injure nerves in Patrick’s pelvis that could lead to incontinence.
If Patrick was Scaife’s son, what would he do? Divricean asked the surgeon.
Scaife told her he’d think on it and give them an answer the next week.
“Hopefully, they’ll come up with something that will save Patrick or will give us a better option at least,” Divricean thought as she waited for the week to pass.
A week later, Scaife had an idea.
Instead of removing Patrick’s blockage, he wanted to break through it — with two powerful magnets.
In the hands of children, strong magnets have proven dangerous, even deadly. When swallowed, they’ve passed into the intestines, and their attraction to each other has forged a hole in tissues.
It occurred to Scaife that in the skilled hands of a surgeon, magnets might be a useful tool instead of a hazard. If he placed a magnet on either side of Patrick’s blockage, their attraction might make a hole and destroy the membrane, allowing stool to pass.
Scaife’s idea was untested and unproven — but if it worked, Patrick wouldn’t need surgery.
Read on for the whole story.
Image: Surgeon, via Shutterstock
Add a Comment