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Preemies Saved by Omega-3s, FDA Drags Feet
8/16/2012
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The intestinal tracts of many premature infants – so-called “preemies” – are underdeveloped.
 
Accordingly, they can’t digest and absorb nutrients from their mother’s milk or standard infant formula … a condition called short bowel syndrome (SBS).
 
Babies with SBS must be fed liquid nutrition formulas via intravenous (IV) lines … an intervention called parenteral nutrition or PN.
 
At any time, some 50,000 American infants are surviving – but not thriving, with many eventually dying – on standard PN diets, which deliver a liquid IV mixture of sugar (glucose), salts, protein, vitamins, and minerals.
 
Omega-6-based PN formula kills livers and babies
The primary fat in standard PN formulas is an omega-6 fatty acid called linoleic acid, derived from plant oils (usually soybean oil).
 
Feeding preemies via PN frequently causes unstable blood sugar or salt levels and inadequate nutrition in premature babies.
 
But the more dangerous drawback to prolonged use of PN is damage to the infant’s liver that can necessitate a liver transplant … if one is available and feasible.
 
This adverse side effect of standard PN formulas is so common it has a name: Parenteral Nutrition Associated Liver Injury (PNALD).
 
Worse, many preemies on prolonged PN die from liver injury … often needlessly, as it turns out.
 
Boston team proved that omega-3s save preemies’ lives
Back in 2001, doctors at Boston’s Children's Hospital found that omega-3 fatty acids prevented fat accumulation in the livers of rats, and possessed anti-inflammatory properties.
 
Five years later, they asked the FDA for special permission to try Omegaven® PN formula in two premature infants made very ill by standard PN formula … with astonishing success.
 
 
It’s been six years since those first cases, and the Boston team – led by Mark Puder, M.D. – has since used omega-3s to save many more babies from injury or death.
 
Importantly, they also conducted a clinical trial that demonstrated the truly dramatic liver- and life-saving effects of the omega-3-based PN formula … a product from Germany called Omegaven® (Le HD et al. 2011).
 
They compared the effects of fish-oil based Omegaven® IV emulsion in 56 infants with SBS who developed PNALD.
 
Their safety and efficacy outcomes were compared with those of 31 premature peers receiving standard PN formula who also suffered from SBS and PNALD
 
The outcomes were clear, with the Omegaven group enjoyed much higher rates of survival and full liver recovery.
 
In fact, none of the Omegaven-fed babies died, versus one in five of the babies on standard, omega-6-based PN formula.
 
FDA drags its feet while babies suffer and die
Despite these stunning successes and the high death and disability rates in preemies with PN-related liver problems, the FDA has still not approved general use of any omega-3-based PN formula.
 
We were fortunate to witness Dr. Puder’s compelling presentation of the clinical and lab evidence at a recent omega-3 conference, and spoke to him afterwards.
 
His deep frustration with the FDA’s delay in approving omega-3-based PN formulas as the “standard of care” for preemies was painfully clear.
 
Now, doctors at Texas Children's Hospital have repeated the Boston success story … and are calling on the FDA to let neonatologists nationwide save babies, now.
 
Texas hospital repeats the Boston success
Texas Children’s Hospital ranked second in U.S. News & World Report’s 2012-13 edition of Best Children’s Hospitals.
 
So it’s very good to hear that TCH has followed the Boston team’s lead, and gained special FDA compassionate permission to use the Omegaven® IV fish oil formula to feed sick preemies and babies.
 
One patient, Pierce Pack, was born three and a half months early at Texas Children’s Hospital. (To see a video featuring interviews with Pierce's mother and doctors, click here.)
 
He had to receive PN, also had intestine surgery and non-invasive heart surgery, and then had his appendix removed and was put on a breathing tube.
 
His doctors decided to try Omegaven® in place of the standard omega-6-based formula on Pierce … and only then did his health improve.
 
“These babies, we have to give them fats in order to make them grow,” said Dr. Steven Abrams, a neonatologist and nutrition researcher at Texas Children’s Hospital. “Omegaven [features] a fat that comes from fish oil, so it’s a very healthy kind of fat.” (Gradney M 2012)
 
Texas Children’s is one of the few medical institutions with special permission from the FDA to administer Omegaven®, and has used it routinely for five years.
 
This exception is great for preemies at Texas Children’s and Boston Children’s, but other hospitals still must request it on a case-by-case basis … and approval can take weeks that sick babies don’t have.
 
 “It’s still listed as an investigational drug,” Dr. Abrams explained. “In order to use it, you have to use it under compassionate protocol. That means you have to tell the FDA the need for it is so important that without it the baby might have a severe consequence or die.” (Gradney M 2012)
 
The evidence that standard, omega-6-based PN formulas hurt preemies while omega-3s heal them is amply clear.
 
What is the FDA waiting for, when babies are suffering and dying needlessly, and the standard PN formula is demonstrably dangerous?
 
We hope that ongoing studies by Dr. Puder’s team and others will convince the FDA to let doctors nationwide save babies’ livers and lives … without having to beg for permission, with the clock ticking.
 
 
Sources
  • de Meijer VE, Gura KM, Meisel JA, Le HD, Puder M. Parenteral fish oil monotherapy in the management of patients with parenteral nutrition-associated liver disease. Arch Surg. 2010 Jun;145(6):547-51.Review.
  • Fallon EM, Le HD, Puder M. Prevention of parenteral nutrition-associated liver disease: role of omega-3 fish oil. Curr Opin Organ Transplant. 2010 Jun;15(3):334-40. Review
  • Gradney M. Doctors say fish oil saves babies, yet not approved by FDA. KHOU 11 News. August 14, 2012. Accessed at http://www.khou.com/community/Doctors-say-fish-oil-saving-babies-yet-not-approved-by-FDA-166124696.html
  • Le HD, de Meijer VE, Robinson EM, Zurakowski D, Potemkin AK, Arsenault DA, Fallon EM, Malkan A, Bistrian BR, Gura KM, Puder M. Parenteral fish-oil-based lipid emulsion improves fatty acid profiles and lipids in parenteral nutrition-dependent children. Am J Clin Nutr. 2011 Sep;94(3):749-58. Epub 2011 Jul 20.
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