Posts Tagged ‘ FDA ’

FDA Proposes New Arsenic Limit for Apple Juice

Monday, July 15th, 2013

The US Food & Drug Administration has announced it will limit the amount of inorganic arsenic allowed in apple juice drinks, proposing a limit that would be the same as is allowed in drinking water. The news comes after decades of debate, which flared in 2011 when Dr. Mehmet Oz released a widely publicized study finding higher-than-allowed amounts of total arsenic in popular brands of apple juice, including Gerber.

Oz’s research did not distinguish between “organic” and “inorganic” arsenic, which scientists liken to cholesterol, which has “good” and “bad” types that should be measured separately.  At the time, Oz argued for the inorganic arsenic level to be lowered to the allowable drinking water level, which the new FDA announcement appears to do.

More on the new ruling from Reuters:

“This action level will keep any apple juice that may have more inorganic arsenic than that out of the marketplace,” Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine, said in a blog post.

Last year the agency tested 94 samples of arsenic in apple juice and found that all were below the 10 ppb threshold for inorganic arsenic. The FDA is now setting that limit as the allowable future benchmark. It will accept public comments on its recommendations for 60 days.

Inorganic arsenic may be found in foods because it is present in the environment, both as a naturally occurring mineral and due to the use of arsenic-containing pesticides.

Inorganic arsenic has been associated with skin lesions, developmental effects, cardiovascular disease, neurotoxicity and diabetes. Organic forms of arsenic, also found in soil and ground water, are considered essentially harmless.

Some consumer groups said the limit on arsenic is a good first step, but the carcinogen needs to be limited further.

“The standard they’ve chosen may not be adequate to fully protect the public,” said Caroline Smith DeWaal, director of food safety at the Center for Science in the Public Interest.

Image: Apple juice, via Shutterstock

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Infant Life-Saving Drug Awaits FDA Approval

Tuesday, June 11th, 2013

Omegaven, a medication developed at Boston Children’s Hospital to save the lives of infants who cannot absorb nutrition, is stuck in the FDA approval process, apparently causing delays that leave parents and doctors alike frustrated and worried.  The drug is a crucial part of treatment for Microvillus Inclusion Disease, a rare genetic condition in which a child cannot absorb fluid or nutrients except through a direct injection of a treatment called total parenteral nutrition, or TPN.  TPN, however, can cause liver damage over time; Omegaven counters that damaging effect.  More from NBC News:

The potentially life-saving medication Omegaven, an intravenous mixture made with fish oil, reduces the fatal fat accumulation in children’s livers caused by TPN. Fish oil contains anti-inflammatory omega-3 fatty acids, which have been shown to prevent fat buildup.

It is unclear when or whether Omegaven will be approved. The normal FDA process for approval is to test medications in large trials that randomly assign patients to receive either the new drug or a placebo. In fatal illnesses, that can present doctors with a tough ethical quandary: Do you do the science right and potentially lose some patients or just keep treating patients in research studies.

Not daunted by the lack of FDA approval, Sam [O’Connor's] family signed him up for a Boston Children’s Hospital research study looking at the new medication’s efficacy.

It didn’t take long to see results.

“For me, it was . . . the personality change,” Debra said. “To have him start responding to me and playing, it’s just like he’s actually a person again. You know, it’s almost like his life started at that point because before it was just enduring.”

Now 5, Sam is one of the lucky ones because he was able to get the drug he needed. Other children aren’t so lucky, says Puder, who developed the Omegaven treatment after watching up to four children die from liver failure each year at his hospital alone.

Without FDA approval, Omegaven is available only to those who can come to Boston to take the drug in a research protocol, or at another hospital with special dispensation from the FDA, a provision called “compassionate use.”

Image: Doctor holding infant, via Shutterstock

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FDA Approves Morning Sickness Drug

Wednesday, April 10th, 2013

The Food and Drug Administration has approved the return of a drug that was widely used to treat morning sickness until it came off the market 30 years ago.  Bendectin, now called Diclegis, will return to the market in early July after extensive study has shown it is safe and effective.  Time.com has more:

Monday’s FDA decision means a new version of the pill once called Bendectin is set to return to U.S. pharmacies under a different name — Diclegis — as a safe and effective treatment for this pregnancy rite of passage.

In the intervening decades, the treatment is widely believed to have undergone more scrutiny for safety than any other drug used during pregnancy.

“There’s been a lot of buzz about this. Nothing better has come along” to treat morning sickness in those 30 years, said Dr. Edward McCabe, medical director for the March of Dimes, who welcomed the step.

“We know safety-wise, there’s zero question,” said Dr. Gary Hankins of the University of Texas Medical Branch in Galveston, who headed one of the company-financed studies of Diclegis that led to its approval.

U.S. sales of Diclegis are expected to begin in early June, according to Canada-based manufacturer Duchesnay Inc. The company has long sold a generic version of the pill in Canada under yet another name, Diclectin.

For all the names, the main ingredients are the same: Vitamin B6 plus the over-the-counter antihistamine doxylamine, found in the sleep aid Unisom. U.S. obstetricians have long told nauseated pregnant women how to mix up the right dose themselves.

In fact, in 2004 the American College of Obstetricians and Gynecologists issued guidelines calling the combination a first-line therapy.

The difference that prescription-only Diclegis would offer: Combining both ingredients with a delayed-release coating designed to help women take a daily dose before their nausea sets in.

This news follows a Danish study last month that showed that Zofran, another morning sickness medication, is also safe.

Image: Woman suffering from nausea, via Shutterstock

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BPA Linked with Childhood Asthma in New Study

Monday, March 4th, 2013

Exposure to the chemical bisphenol A, which is found in some plastics, food cans, and a number of other consumer products, has been linked with a higher risk of childhood asthma, a new study conducted by researchers at the Columbia Center for Children’s Environmental Health has found.  More from CNN:

A child’s chances of suffering with asthma were increased if BPA was detected in their urine samples at ages 3, 5 and 7. In addition, when BPA was measured in urine at age 3, the chances of wheezing by ages 5 and 6 were increased. Same thing for 7-year-olds: BPA meant later problems with wheezing.

An exception to the findings occurred among children with BPA measured in their urine at 5 years of age; those children did not have problems with wheezing during follow-ups one or two years later.

“What is important is that we were seeing the association at routine low doses of exposure,” said Dr. Kathleen Donohue, the lead study author.

One anomalous finding in the study, published Friday in the Journal of Allergy and Clinical Immunology: If BPA was detected in a mother’s urine during her third trimester of pregnancy, there was less likelihood that her child would have breathing problems at age five – the opposite of what researchers expected.

Government agencies consider BPA to be a product of concern, but have stopped short of banning it in all consumer products.  Last year, the FDA banned BPA from all baby bottles and sippy cups.

Image: Child with asthma, via Shutterstock

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FDA Warning Changes Feeding Treatment for Some Premature Babies

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

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