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Daily Dose

Confusion Over Cough & Cold Medicines

The confusion over cough and cold medications continues and I must admit I am a little confused too. The Consumer Healthcare Products Association recently announced changes to the labeling of over-the-counter (OTC) cold products to state "do not use in children under 4 years of age". The FDA monograph still states "do not use in children under 2 years". The American Academy of Pediatrics recommends not using OTC cough and cold preparations in children under six years.

Looking at the little research on these products two things come to mind:

  1. There have been multiple studies done on these products (in adults) that do not show them to be efficacious for treating common cough and cold symptoms.
  2. The research among children using these products show that dosing errors and accidental ingestions are the leading cause of adverse events.

This kind of leaves me thinking why use them at all in children? I really have never been much of a cold medicine giver in general, as I personally did not see my patients getting better any faster nor my own children. We continued to use the good old grandmother tested remedies of lots of rest, fresh squeezed orange juice (sometimes in pays to be sick), chicken noodle soup (canned or home made), and a vaporizer or humidifier in their rooms at night. I also know that younger children get more colds than anyone and no matter what you do you have to get through that too. But miraculously, as kids get older they get less colds and seem to tolerate them a little better. So... for this winter in our practice we are not recommending the use of any of these products for kids and trying the gold standards rest, fluids, cool mist humidifier and tincture of time. We'll see how it goes. That's your daily dose, we'll chat tomorrow.

Your Baby

Gerber Recalls Two Batches of Organic Baby Foods

1:30

Gerber Products Company is voluntarily recalling specific Organic pouch products after identifying a packaging defect that may result in product spoilage during transport and handling.

The two kinds of Gerber Organic 2nd Foods Pouches being recalled are: Pears, Carrots and Peas and the other is Carrots, Apples and Mangoes, the company said.

“Consumers may notice that, in some cases, the pouches are bloated and product inside may have an off taste or odor. There have been three consumer reports of temporary gastrointestinal symptoms, however, we have been unable to confirm that these are related to the product. Consumers should not use the product, since it does not meet our high quality standards,” the company said in a statement.

The products were distributed at U.S. retailers nationwide and through on-line stores. Consumers who purchased pouches with UPCs, batch codes and expiration dates listed below, are encouraged to contact the Gerber Parents Resource Center at 1-800-706-0556 anytime day or night for a replacement coupon.

Replacement coupons are being offered for the following products:

GERBER® Organic 2ND FOODS® Pouches –Pears, Carrots & Peas, 3.5 ounce pouch UPC 15000074319

Best By dates/batch codes

•       12JUL2016 51945335XX

•       13JUL 2016 51955335XX

GERBER® Organic 2ND FOODS® Pouches- Carrots, Apples and Mangoes, 3.5 ounce pouch UPC 15000074395

Best By dates/batch codes

•       13JUL2016 51955335XX

•       14JUL2016 51965335XX

Consumers can also find more information on the Gerber Products Company website at https://www.gerber.com/recall-march-2016

Story source: http://www.fda.gov/safety/recalls/ucm492260.htm#recall-photos

Your Teen

FDA to Regulate E-cigarettes, Raise Age for Purchasing

2:00

Cigarette smoking among teens and young adults has been on a slight decline in the past few years, but e-cigarette use has been rapidly increasing.

Because there are no regulations and scant information on the products used to fuel e-cigarettes, many leading health organizations, including the American Academy of Pediatrics have been urging the Federal Drug Administration (FDA) to bring e-cigarettes and liquid nicotine under its authority.

The U.S. government has responded and taken action. The FDA issued a tough set of rules for the e-cigarette industry that included banning sales to anyone under 18, requiring package warning labels, and making all products—even those currently on the market—subject to government approval.

For many teen and health organizations, the ruling has been long overdue.

Though the product-approval process will be phased in during three years, that will be little solace to the fledgling but fast-growing $3.5 billion industry that has, until Aug. 8 when the rules take effect, largely been unregulated and dominated by small manufacturers and vape shops.

Many of the vape shops, device manufacturers and liquid nicotine producers are not happy with the change.

“This is going to be a grim day in the history of tobacco-harm reduction,” said Greg Conley, president of the American Vaping Association, an industry-funded advocacy group. “It will be a day where thousands of small businesses will be contemplating whether they will continue to stay in business and employ people.”

In June, the FDA proposed requiring warning labels and childproof packaging because of an increase in nicotine exposure and poisoning incidents. The agency could move to regulate advertising or flavors such as cotton candy and watermelon that also might appeal to youth.

“We’re looking at the flavor issue with e-cigarettes,” said FDA Tobacco Center Director Mitch Zeller during a news conference. Later, he said, that while the agency was aware of “anecdotal reports” that e-cigarettes have helped smokers kick their habit; those benefits were outweighed by concerns about youth using the devices.

E-cigarettes are not the only tobacco related products that will come under the control of the FDA. Unregulated tobacco items, including pipe tobacco and water-pipe tobacco, will also fall under the supervision of the FDA.

The FDA has been regulating cigarettes since Congress granted it oversight of traditional smokes with the 2009 Family Smoking Prevention and Tobacco Control Act.

“Today’s announcement is an important step in the fight for a tobacco-free generation—it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions,” Department of Health and Human Services Secretary Sylvia Mathews Burwell said in a statement.

Most researchers agree e-cigarettes are less harmful than cigarettes because, unlike cigarettes, they don’t combust. Studies have shown that when traditional cigarettes combust they release more than 60 carcinogens. But the long-term effects of using the electronic devices remain largely unknown, and many anti-tobacco groups and public health officials are concerned they could become a gateway to traditional smoking.

Anti-tobacco groups have been frustrated with FDA, saying the agency has taken far too long to finalize its rules.

Concerns escalated when a study published in August by the Journal of the American Medical Association found ninth-graders who used e-cigarettes were 2½ times as likely as peers to have smoked traditional cigarettes a year later.

The Centers for Disease Control and Prevention reported in April that e-cigarette use tripled among U.S. teenagers in 2014.

The AAP issued its recommendations on tobacco and e-cigarettes in late 2015.

In a press release, the organization said it strongly recommends the minimum age to purchase tobacco products, including e-cigarettes, should be increased to age 21 nationwide.

"Tobacco use continues to be a major health threat to children, adolescents and adults," said Karen M. Wilson, MD, MPH, FAAP, chair of the AAP Section on Tobacco Control and section head of Pediatric Hospital Medicine at Children's Hospital Colorado. "The developing brains of children and teens are particularly vulnerable to nicotine, which is why the growing popularity of e-cigarettes among adolescents is so alarming and dangerous to their long-term health."

Under the new rules, e-cigarette manufacturers would have up to two years to continue to sell their products while they submit an application to the FDA.

Story sources: Tripp Mickle, Tom Burton, http://www.wsj.com/articles/fda-to-regulate-e-cigarettes-ban-sales-to-minors-1462455060

https://www.aap.org

 

Your Baby

FDA Recommends Limits on Arsenic in Rice Baby Food

1:45

The Food and Drug Administration (FDA) on Friday proposed new limits for inorganic arsenic in infant rice cereal, an effort to reduce the leading source of arsenic exposure for babies.

The draft guidance to industry would cap the inorganic arsenic at 100 parts per billion, a level that most infant rice cereals already meet, or are close to meeting, the agency said.

Arsenic is naturally present in water, air, food and soil in two forms: organic and inorganic. Organic arsenic passes through the body quickly and is less toxic. But inorganic arsenic may pose a cancer risk if consumed at high levels or over a long period of time. Rice is thought to have arsenic in higher levels than most other foods because it is grown in water on the ground, optimal conditions for the contaminant to be absorbed.

Babies' consumption of rice, which is primarily through rice cereal, is about three times greater than that of adults, according to the FDA. Most people consume the highest amount of rice, relative to their weights, at about 8 months of age.

The proposed limit is based on testing of rice and non-rice products, as well as a 2016 FDA risk assessment on the association between exposure to inorganic arsenic and adverse pregnancy outcomes and neurological effects in early life.

The agency said that inorganic arsenic exposure can result in a child's decreased performance on certain developmental tests.

The agency tested 76 samples of infant rice cereal from retail stores and found that nearly half met the agency's proposed limit of 100 parts per billion of inorganic arsenic. More than three-quarters of the samples had levels at or below 110 parts per billion.

The agency advised parents to feed their babies iron-fortified cereals; they can include oat, barley and other grains. It also urged pregnant women to consume a variety of foods, including grains, such as wheat, oats and barley. The FDA also noted that cooking rice in excess water - six to 10 parts water to one part rice - can reduce a significant part of the inorganic arsenic.

Urvashi Rangan, executive director of the Consumer Reports Food Safety & Sustainability Center, said that Consumer Reports was pleased by the FDA's proposal, which he said was close to the level proposed by the group three years ago. But he said the organization remains concerned that other rice-based products consumed by children and adults don't have any such standards. "This is particularly true of children's ready-to-eat cereals," he said, urging the FDA to set levels for these other products.

The agency will accept public comments on the proposed limits for 90 days.

Story source: Laurie McGinley, http://www.chicagotribune.com/lifestyles/health/ct-infant-rice-cereal-inorganic-arsenic-20160402-story.html

 

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