Labeling for Pediatric Medications

pediatricThe Food and Drug Administration (FDA) has made it easier for parents and health care professionals to find information on pediatric medications. The FDA created a database that covers medical products studied in children under recent pediatric legislation.

The C4 is a one-stop resource. You can search for information by the product’s commercial or chemical name, or by the condition for which it was studied. FDA’s Office of Pediatric Therapeutics (OPT), which focuses on safety, scientific, and ethical issues that arise in pediatric clinical trials or after products are approved for use in children, developed the tool in collaboration with another branch of the agency, the Center for Drug Evaluation and Research.

OPT also maintains a Safety Reporting page5 with information on products that have been tied to safety problems that specifically relate to children. This page lists products that have been the subject of an adverse event report presented to FDA’s Pediatric Advisory Committee, a group of outside experts that advises the agency on pediatric treatments, research and labeling. (An adverse event is any undesirable experience associated with a medical product.)  The committee’s recommendation is also given if further actions were necessary to ensure safe use of the product in children.

“We are excited to share this goldmine of information with parents,” says Debbie Avant, R.Ph., the health communications specialist in OPT who helped develop and maintain the database. “We want parents to know they can rely on FDA for accurate, timely information about the medications their children take.”

Pediatric Medication Labels

Parents should always read medicine labeling carefully. For prescription medications and vaccines, there is a Pediatric Use section in the labeling that says if the medication has been studied for its effects on children. The labeling will also tell you what ages have been studied. (This labeling is the package insert with details about a prescription medication.)

Congress’ efforts to increase the number of studies of prescription drugs used in children have allowed FDA to build a foundation for pediatric research and discover new things. For example, researchers have found that certain drugs produce more side effects for the nervous system in children than adults, says Dianne Murphy, M.D., OPT’s director.

FDA is able to use information gathered from pediatric studies to make labeling changes specific to kids, and to share that news with the public. The database, which is updated regularly, currently contains more than 440 entries of pediatric information from the studies submitted in response to pediatric legislative initiatives. The labeling changes include:

  • 84 drugs with new or enhanced pediatric safety data that hadn’t been known before;
  • 36 drugs with new dosing or dosing changes;
  • 80 drugs with information stating that they were not found to be effective in children; and
  • 339 drugs for which the approved use has been expanded to cover a new age group based on studies.

The easiest way for parents to use the database is to search by their child’s condition to find all mentions of that condition in all of the labeling information within the database. If you know the name of the drug you want to find, sort the database’s information by trade name.

Avant says parents should note that the database contains the version of the label at the time of the labeling change. It may not be updated with later changes if they don’t affect children.

OPT has also evaluated the amount of progress in the inclusion of pediatric information in drug labeling and has published a research letter in the Journal of the American Medical Association67on May 9, 2012. They found that in 2009, more than 60% percent of the drugs used for both adults and children that were in the Physician’s Desk Reference—a drug information resource for physicians and other health professionals—had specific information on pediatric use, compared to only 22 percent in 1975.

Critical information in the pediatric section of the labeling tells you if the product was studied in children but could not be shown to work. When a product has been studied in adults and cannot be shown to be effective, that information is not put in the label. However, Congress told FDA to put this information in labeling when a product had been studied in children and was not effective.

“There is still much work to be done, as we have only studied two thirds of the products that are already on the market,” says Murphy. “And there is a steady stream of new products approved every year for children and adults.”

Source : FDA Consumer Updates page

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How Clean is your Toothbrush?

Researchers at England’s University of Manchester say your toothbrush can be a breeding place for germs.

They found that one uncovered toothbrush can harbor more than 100 million bacteria, including E. coli bacteria, which can cause diarrhea, and staphylococci (“staph”) bacteria that cause skin infections.

toothbrushSo, how safe is your toothbrush?

Well, according to Gayle McCombs, RDH, MS, associate professor and director of the Dental Hygiene Research Center at Old Dominion University, “There are hundreds of microorganisms in our mouths each and every day. But problems only start when there is an unhealthy balance of bacteria in the mouth.”

Oral hygiene experts agree that no matter how many bacteria live in your mouth, or have gotten in there from your toothbrush, your body’s natural defenses make it most unlikely that you will get sick from brushing your teeth.

Here are some recommended common sense storage toothbrush storage tips from the experts:

  • Don’t Brush Where You Flush – Every toilet flush sends a spray of bacteria into the air. You don’t want the toilet spray anywhere near your open toothbrush. McCombs says. “It’s just common sense to store your toothbrush as far away from the toilet as possible.”
  • Once you’ve moved your toothbrush away from the toilet, here are a few other storage tips to keep your brush as germ-free as possible:
    • Wash off your toothbrush thoroughly with tap water every time you use it.
    • “Bacteria love a moist environment,” Harms says. Make sure your brush has a chance to dry thoroughly before you use it again. Avoid using toothbrush covers, which can create a moist enclosed breeding ground for bacteria.
    • Store your toothbrush upright in a holder, rather than lying it down.
    • No matter how close you are to your sister, brother, spouse, or roommate, don’t ever use their toothbrush. Don’t even store your toothbrush side-by-side in the same cup with other people’s brushes. Whenever toothbrushes touch, they can swap germs.

Source: WebMD

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How Much is Enough Food for a 4-8 Year Old?

foodWith all the concerns about children’s food consumption, and gaining unhealthy amounts of weight, the following guidelines, on what to feed children 4-8 years old, may prove helpful.

The guidelines are from WebMD (fit.webmd.com).

DAIRY

Total Servings a Day: 4

Look for reduced-fat, low-fat, or skim.

1 Serving Size

Milk

1/2 to 3/4 cup

Cheese

Choose 1:

• 2 to 3 dice-sized cheese cubes

• 1/2 to 1 slice packaged cheese

Yogurt

1/2 cup to 3/4 cup (4 to 6 oz)

PROTEIN

Total Servings a Day: 2

Make most meat choices lean or low-fat.

1 Serving Size

Meat, Fish, Poultry, or Meat Substitute

1 oz (about the 1/3 to 1/2 the size of an adult’s palm)

Tofu or Tempeh

1/2 cup

Egg

1 egg

4 Tbsp (about the size of your child’s fist)

Beans or Peas

Nuts (includes peanut butter)

2 Tbsp

VEGETABLES

Total Servings a Day: 4 to 8

Serve mostly green or brightly colored veggies.
Limit starchy veggies like potatoes.

1 Serving Size

3 to 4 Tbsp

Starchy Vegetables (like white potatoes)

Limit to 1 to 2 servings a day.

FRUIT

Total Servings a Day: 2

Raw fruit is best.

1 Serving Size

Choose 1:

• 1/2 to 1 small raw fruit

• Canned 4 to 6 Tbsp

Opt for fruit packed in water, juice, or light syrup
instead of heavy syrup.

4 to 6 oz total per day

Fruit Juice

GRAINS

Total Servings a Day: 4

Choose whole-grain options when possible.

1 Serving Size

Choose 1:

• 1 slice of bread

• 1/2 English muffin

• 1/2 Bagel

• 1/2 to 1 Tortilla

Cooked cereal

1/2 cup

Cold, Dry cereal

1 cup

Pasta, noodles, rice or grains

1/2 cup

Sources:

Pediatric Nutrition Handbook 6th edition, American Academy of Pediatrics Committee on Nutrition. 2009.

American Cancer Society: “Controlling Portion Sizes.”

Let’s Move: “Healthy Families.”

A Parent’s Guide to Childhood Obesity, American Academy of Pediatrics. 2006.

© 2011 WebMD

fit.webmd.com

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Reducing Sodium in Restaurant Foods

 The Centers for Disease Control (CDC) shares the following press release reminding us to consider how much sodium we may be consuming when we eat out.

Americans eat out at fast food or dine-in restaurants four or five times a week. Just one of those meals might contain more than an entire day’s recommended amount of sodium.  CDC has strategies for health departments and restaurants to work together to offer healthier choices for consumers who want to lower their sodium intake. The report, “From Menu to Mouth: Opportunities for Sodium Reduction in Restaurants,” is published in the CDC’s journal, Preventing Chronic Disease.

sodiumOn average, foods from fast food restaurants contain 1,848 mg of sodium per 1,000 calories and foods from dine-in restaurants contain 2,090 mg of sodium per 1,000 calories.

The U. S. Dietary Guidelines recommend the general population limit sodium to less than 2,300 mg a day. Too much sodium can cause high blood pressure, one of the leading causes of heart disease and stroke.

“The bottom line is that it’s both possible and life-saving to reduce sodium, and this can be done by reducing, replacing and reformulating,” said CDC Director Tom Frieden, M.D., M.P.H. “When restaurants rethink how they prepare food and the ingredients they choose to use, healthier options become routine for customers.”

The report outlines several ways health departments and restaurants have worked together to offer lower-sodium choices:

  • Health department dietitians help restaurants analyze the sodium content of their foods and recommend lower-sodium ingredients.
  • Restaurants clearly post nutrition information, including sodium content, at the order counter and on menus or offer lower-sodium items at lower cost.
  • Health departments and restaurants explain to food service staff why lower sodium foods are healthier and how to prepare them.

The report also features examples of sodium reduction successes.  In Philadelphia, the health department worked with 206 restaurants to create the “Philadelphia Healthy Chinese Take-out Initiative.”  After evaluating menus for sodium content, participating restaurants began choosing lower sodium ingredients and creating lower sodium recipes. After nine months, analyses of two popular dishes offered by 20 of the restaurants showed sodium was reduced by 20 percent.

“The story in Philadelphia shows what can be done,” Dr. Frieden said. “It’s not about giving up the food you love, but providing lower sodium options that taste great.”

To learn more about sodium and how it affects health, visit www.cdc.gov/salt.  Reducing sodium is one way that Million Hearts, a national public-private initiative to prevent a million heart attacks and strokes by 2017, is working with communities to keep people healthier and less likely to need health care www.millionhearts.hhs.gov.

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

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What Can You Eat for 100 Calories?

The 100 calorie packs available in most major food markets can be a handy way to maintain snack portion control between meals for kids and adults.

The challenge… read the nutrition label and see what the salt, fat, and carbohydrate intake is in this low calorie snack. It may be 100 calories, but it is not necessarily a healthy snack.

The site, fruits & veggies, more matters, at www.fruitsandveggiesmorematters.org/healthy-weight-management,  issued a 100 calorie list of foods that make for healthy and low calorie snacking. Here are their suggestions:

 100 Calorie Snacks

Tortilla Chips  – 3/4 c

Strawberries –  2 cups

Sliced Peppers –  2 cups

Pretzels –  1 ounce

Muffin  – 1 ounce (1 mini)

Lettuce, shredded -20 cups

Ice Cream (not premium) 3/8 cup

Fresh Blueberries  – 1 1/4 cup

Donut 3/8 –  whole

Cucumbers, sliced  – 7 cups

Chocolate Chip Cookies – 2-2inch cookies

Cherry Tomatoes –  4 cups

Cheese P-Nut Butter Snack Cracker  – 3

Cantaloupe Cubes – 2 cups

Canned Peaches (in juice) – 1 1/2 cup

Bagel –  1/4 of 5 oz. bagel

Baby Carrots – 2 cups

Apple Slices –  2 cups

American Cheese (thin slices) -2 slices

100% Vegetable Juice -2 cups (16 fluid ounces)

100% Orange Juice – 7 fluid oz.

Happy Snacking on 100 Calories!

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