FDA Warns Not to Feed SimplyThick to Premature Infants
Washington, DC, United States (AHN) – Do not feed the thickening product called SimplyThick to infants born before 37 weeks because it may cause a life-threatening condition.
This advice to parents, caregivers, and health care providers from the Food and Drug Administration (FDA) is based on reports of infants with necrotizing enterocolitis (NEC) in which tissue in the intestines becomes inflamed and die
SimplyThick is a brand of thickening agent—available to consumers and medical centers—to help manage swallowing difficulties. It 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.
Benson M. Silverman, M.D., director of FDA’s Infant Formula and Medical Foods Staff—himself a neonatologist—explains that the thickening agent is added to infants’ formula to help the premature babies swallow their food and keep it down, without spitting up. The product is also used in older children and adults with swallowing problems caused by trauma to the throat, he notes.
The Problem
FDA first learned of bad side effects possibly linked to SimplyThick on May 13, 2011. Silverman says he was alerted by two reports in FDA’s MedWatch Adverse Event Reporting system. He followed up with the physicians who filed those reports and subsequently with a network of other neonatologists.
Karl Klontz, M.D., a medical officer in FDA’s Center for Food Safety and Applied Nutrition, says the severity and scope of the problem soon became apparent. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick mixed with mothers’ breast milk or infant formula products. The mixture was fed to infants for varying amounts of time.
At least four different medical centers around the U.S. have reported the illness in infants who became sick over the past six months.
This situation is unusual because NEC most often occurs in babies while they are in the hospital early in their premature course. But some of the ill babies that FDA is aware of got sick after they had been discharged from the hospital and sent home on a feeding regimen that included SimplyThick.
At this time it is not known what about SimplyThick is making babies sick. FDA is actively investigating the link between SimplyThick and these illnesses and deaths.
In the meantime, adds Klontz, parents should stop using the product even if their babies don’t appear to be sick. “Why take the risk?” he asks.
Symptoms to Watch for
- bloated stomach
- greenish-tinged vomiting
- bloody stools
Do not feed SimplyThick to premature infants, including those in the hospital and those sent home from the hospital within the past 30 days.
Contact your health care professional if your baby has any of the symptoms listed above or if you have other concerns related to using SimplyThick.
You or your health care professional may report side effects related to using SimplyThick to FDA’s MedWatch Safety Information and Adverse Event Reporting Program by:
Completing and submitting the report online: www.fda.gov/MedWatch/report.htm;
Downloading the pre-addressed, postage-paid FDA Form 3500 (or calling 1-800-332-1088 to request the form), completing it and faxing it to 1-800-FDA-0178; or Mailing the completed form to MedWatch 5600 Fishers Lane, Rockville, MD 20857.
What FDA Is Doing
FDA is actively investigating the link between SimplyThick and the illnesses and deaths. FDA will provide updates as information is made available.
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New Research Study: Statins May Stave Off Septic Lung Damage
Statins may be best known for their ability to reduce cholesterol, but a research report appearing in the May 2011 issue of the Journal of Leukocyte Biology shows that these same drugs could also play a crucial role in the reduction of lung damage resulting from severe abdominal sepsis and infection. “We hope that this study will not only provide new knowledge about the complicated pathophysiology behind abdominal sepsis, but also form the basis for more effective and specific treatment options for patients with severe infections,” said Henrik Thorlacius, M.D., Ph.D…
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Homogenized milk may cause you a heart attack
Tina Ranieri In a book by Kurt A. Olster, M.D.,Homogenized Milk May Cause Your Heart Attack: The XO Factor, that is causing worldwide alarm, it seems milk has been under investigation since 1932 or rather the process itself, homogenization. The cholesterol… March 10, 2011
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Western Baptist Offers Classes & Events in Feb.
Western Baptist Hospital holds free classes, seminars and other activities to educate and celebrate healthcare in this region. The February events are listed here: Relaxing from Within
5 to 6:30 p.m., Tuesday, Feb. 1, Atrium Classroom, Doctors Office Building 2, Western Baptist Hospital
Free class designed to help expectant mothers become familiar with relaxation techniques. Participants are asked to bring a blanket, pillow and support person.
Phone (270) 575-2229 for more information.
Western Baptist Prepared Childbirth Classes
5 to 8 p.m., Monday, Feb. 7 and 14, or 9 a.m. to 3 p.m., Saturday, Feb. 19, Meeting Room A, Doctors Office Building 2, Western Baptist Hospital
Free class designed to help expectant parents in their second or third trimester learn about the labor and delivery process.
Phone (270) 575-2229 to register.
Brunch Bunch
10 a.m. to noon, Tuesday, Feb. 8, Baptist Heart Center Auditorium, Western Baptist Hospital.
Speakers will be cardiologist Patrick Withrow, M.D., and dermatologist Hal Ford, M.D., on being healthy on the inside and out.
Phone (270) 575-2851 or e-mail lora.croley@bhsi.com for more information.
Girl Talk
4 to 6 p.m., Tuesday, Feb. 8, Atrium Classroom, Doctors Office Building 2, Western Baptist Hospital.
Free class to help preadolescent girls learn about their changing bodies and help them feel more self-confident and assured about becoming women.
Phone (270) 575-2229 to register.
Breastfeeding Classes
9 to 11 a.m., Saturday, Feb. 12, or 6:30 to 8:30 p.m., Monday, Feb. 28, Atrium Classroom, Doctors Office Building 2, Western Baptist Hospital
Free class helps prepare expectant mothers for the breastfeeding experience.
Phone (270) 575-2229 to register.
Diabetes classes
1 to 4 p.m., Monday, Feb. 14, and Wednesday, Feb. 16, Atrium Classroom, Doctors Office Building 2, Western Baptist Hospital.
Free class with a certified diabetes instructor to assist with any question or concerns about diabetes. A physician’s order is required.
Phone (270) 575-2918 for more information.
Cesarean Birth Class
5 to 8 p.m., Tuesday, Feb. 14, Meeting Room A, Doctor’s Office Building 2, Western Baptist Hospital
Prepares mothers for a Cesarean delivery.
Phone (270) 575-2229 to register.
Look Good…Feel Better
2 to 4 p.m., Tuesday, Feb. 15, Baptist Heart Center conference room, Western Baptist Hospital
Free program designed to help women look their best during cancer treatment. Experienced cosmetologists teach beauty tips to help minimize the appearance-related side effects of chemotherapy and radiation
Phone (270) 444-0384 for reservations.
Smart Beginnings Childbirth Class
4 to 6 p.m., Tuesday, Feb. 15 and 22, Atrium Classroom, Doctors Office Building 2, Western Baptist Hospital.
Free class designed for pregnant teens or the non-traditional family unit to help them learn about the labor and delivery process.
Phone (270) 575-2229 to register.
Heart Check
9 a.m. to noon, Friday, Feb. 25, Atrium of Doctors Office Building 2, Western Baptist Hospital.
Free health screenings, including blood pressure, cholesterol and EKG rhythm strips. No advance registration or fasting is necessary.
Phone (270) 575-2918 for more information.
Sibling Class
5 to 6 p.m., Monday, Feb. 28, Atrium Classroom, Doctors Office Building 2, Western Baptist Hospital
Free class helps prepare children ages 2 to 9 for the arrival of a new brother or sister.
Phone (270) 575-2229 to register.
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Heart Check Offers Free Screenings Feb. 25
To commemorate American Heart Month, Western Baptist offers free heart screenings from 9 am to noon Friday, Feb. 25, in the atrium of Doctors Office Building 2 at the hospital. Western Baptist staff will provide free blood pressure, blood sugar, cholesterol and EKG rhythm strip screenings, as well as heart-healthy information during Heart Check. Fasting and advance registration are not required. In addition, cardiologist Patrick Withrow, M.D., vice president and chief medical officer of Western Baptist Hospital, will be available to answer questions. Monitoring risk factors, such as blood pressure and cholesterol, is important in the prevention of heart disease, which remains the nation’s leading killer. Western Baptist has been named a gold award winner for coronary artery disease treatment by the American Heart Association and received a Top Improvement Award for bypass surgery from Centers for Medicare and Medicaid. It has the area’s first heart center and nationally accredited chest pain center. Western Baptist offers a free, five-minute heart risk assessment at www.westernbaptist.com/heart and a 24-hour Chest Pain & Stroke Hotline staffed by nurses at 1-800-575-1911. For more information, phone the Baptist Health Line at 270-575-2918.
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It’s Beginning To Look A Lot Like…Heart Attack Season
It may be the most wonderful time of the year, but Advent Consumer Healthcare, LLC wants to prepare people for the uptick in coronaries that comes with the holidays. Research shows that heart attack deaths begin to increase around Thanksgiving, continue to rise through Christmas, peak on New Year’s Day, and then drop off. In addition to known risk factors such as high cholesterol, hypertension, and smoking, experts point to overindulgence and stress as major contributors to this less than merry phenomenon. With the increase of heart attacks over the holidays, Thomas B. Graboys, M.D…
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Lower Your Cholesterol and Increase Your Chance of Stroke
Recently, The New York Times published an article entitled – “U.S. calls for major cholesterol reductions” and which was also printed in numerous local papers.
Sounds like a great way to fight heart disease, right?
Let’s take a look at what the article does not tell you about lowering your cholesterol. Because you must understand the effects of artificially lowering your cholesterol levels without implementing other strategies which are crucial to your health.
Because the fact of the matter is the Framingham Heart study – which has followed people for over 5 decades – proved without a doubt that LDL cholesterol is just one of many misleading factors of heart disease.
In fact, LDL cholesterol levels are only a very minor factor of heart disease and only under certain conditions.
Here is a quote from Christie Ballantyne, M.D., a cardiologist from the Baylor College of Medicine – “The majority of people who end up having heart attacks or stroke don’t have high cholesterol.”
Here is another quote from an article in the Red Flags Daily By Malcolm Kendrick, M.D. who talks about the Framingham Study results as published in the Journal of the American Medical Association.
“There is a direct association between falling cholesterol levels over the first 14 years and mortality over the following 18 years.”
You guessed it, the mortality rate goes UP.
Scientific research has also proved without a doubt that as people lower their LDL cholesterol level, their chances for stroke go up.
Using cholesterol lowering drugs may artificially lower cholesterol levels, however, they will also increase the death rate from stroke. And because of toxicity to the body, you will also face liver and kidney failure.
You see, your body not only produces cholesterol, it also needs cholesterol for a variety of functions. Cholesterol is an essential part of each and every cell membrane.
Cholesterol also provides the critical starting point and building block for the steroid hormones in our bodies. These hormones include testosterone and estrogen.
As you can see, cholesterol itself is not bad. It is the oxidation of cholesterol which is just one of the factors of developing heart disease.
Oxidation of cholesterol is the more specific problem which would enable the cholesterol to become “sticky” and start to form plaque in the walls of the arteries.
We have all seen an apple cut open and watch as it turns brown – this is oxidation. Your body will oxidize on the inside unless steps are taken to help prevent this.
The way to keep oxidation from damaging your cholesterol is to zap them with antioxidants!
You can keep oxidation of cholesterol in check by eating plenty of food and supplements which are rich in anti-oxidants.
A few of the most powerful anti-oxidants are:
CoenzymeQ10
Vitamin E
Vitamin A
Vitamin C
And the mother of all anti-oxidants – Alpha-lipoic acid (ALA).ALA is produced naturally by your body but, as you age, your body produces less and less.
Low cost food sources which you can easily get, which are high in omega 3′s and the right fats to help keep your cholesterol levels in balance.
Garlic
Ginger
Olive oil
Olives
Almonds
Walnuts
Flaxseed
Eggplant
Okra
Organic Eggs
Fresh fruit
These are easily purchased, safe, proven and natural ways to prevent cholesterol from becoming a problem.
And if you are someone who truly needs to lower their cholesterol, there is an organic plant alcohol from sugar cane which is one of the most powerful ways to reduce bad cholesterol levels. It’s called – Policosanol.
As for the majority of you, focus on raising your HDL cholesterol levels because as you raise your good cholesterol it decreases the concern about your LDL levels of cholesterol and gives you a better total cholesterol profile.
Some of the best ways to improve your “Good” or HDL cholesterol is through:
Exercise.
Vitamin D
Niacin
Moderate alcohol consumption is associated with raising HDL cholesterol levels
Sources:
Framingham Heart Study conducted on healthy people since the 1950s. cholesterol misleading as only one of 240 factors in heart disease.
Health Sciences Institute e-alert “Cholesterol Cowboys”, August 2nd , 2004, Jenny Thompson
Dr. Al Sears Health Confidential for Men – “Ignore the hype focus on cholesterol that matters” April 4, 2004
Hyman, Mark M.D., Liponis, Mark M.D., Ultra-Prevention, The 6-Week Plan that will Make you healthy for life, New York, Scribner, 2003
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Author: Lee Cummings
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