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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What are Empty Calories?

MyPlate.gov., a division of the Dept. of Agriculture offers the following information about foods we eat, and really enjoy, that really don’t give us the nutrients we need but do give us what are referred to as “empty calories.”

caloriesMany of the foods and beverages Americans eat and drink contain empty calories –- calories from solid fats and/or added sugars. Solid fats and added sugars add calories to the food but few or no nutrients. For this reason, the calories from solid fats and added sugars in a food are often called empty calories. Learning more about solid fats and added sugars can help you make better food and drink choices.

Solid fats are fats that are solid at room temperature, like butter, beef fat, and shortening. Some solid fats are found naturally in foods. They can also be added when foods are processed by food companies or when they are prepared. Added sugars are sugars and syrups that are added when foods or beverages are processed or prepared.
Solid fats and added sugars can make a food or beverage more appealing, but they also can add a lot of calories. The foods and beverages that provide the most empty calories for Americans are:

  • Cakes, cookies, pastries, and donuts (contain both solid fat and added sugars)
  • Sodas, energy drinks, sports drinks, and fruit drinks (contain added sugars)
  • Cheese (contains solid fat)
  • Pizza (contains solid fat)
  • Ice cream (contains both solid fat and added sugars)
  • Sausages, hot dogs, bacon, and ribs (contain solid fat)

These foods and beverages are the major sources of empty calories, but many can be found in forms with less or no solid fat or added sugars. For example, low-fat cheese and low-fat hot dogs can be purchased. You can choose water, milk, or sugar-free soda instead of drinks with sugar. Check that the calories in these products are less than in the regular product.

In some foods, like most candies and sodas, all the calories are empty calories. These foods are often called “empty calorie foods.” However, empty calories from solid fats and added sugars can also be found in some other foods that contain important nutrients. Some examples of foods that provide nutrients, shown in forms with and without empty calories are:

 

Food with some empty calories Food with few or no empty calories
Sweetened applesauce (contains added sugars) Unsweetened applesauce
Regular ground beef (75% lean) (contains solid fats) Extra lean ground beef (96% or more lean)
Fried chicken (contains solid fats from frying and skin) Baked chicken breast without skin
Sugar-sweetened cereals (contain added sugars) Unsweetened cereals
Whole milk (contains solid fats) Fat-free milk

Making better choices, like unsweetened applesauce or extra lean ground beef, can help keep your intake of added sugars and solid fats low.

A small amount of empty calories is okay, but most people eat far more than is healthy.

It is important to limit empty calories to the amount that fits your calorie and nutrient needs. You can lower your intake by eating and drinking foods and beverages containing empty calories less often or by decreasing the amount you eat or drink.

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USDA Offers Summer Food Safety Tips In Advance of Memorial Day Weekend

foodWarmer temperatures call for extra attention to food safety when cooking and eating outdoors.

Memorial Day weekend marks the unofficial start to summer, and many Americans will celebrate with cookouts, camping, road trips and other activities that involve food. The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is reminding families to take extra care not to let foodborne bacteria, which grows more quickly in hot weather, ruin the fun.

“This Memorial Day weekend and all summer long, I encourage families to get outside and enjoy our natural resources, national parks and forests, and the variety of food America’s farmers are able to provide,” said Agriculture Secretary Vilsack. “It’s important to remember that bacteria grow faster in the same warm temperatures that people enjoy, so extra care needs to be taken to prevent food poisoning when preparing meals away from home. USDA reminds everyone to use a food thermometer, and take advantage of resources like our FoodKeeper app to help with any food handling questions.”

The USDA recently launched its FoodKeeper mobile app, which contains specific guidance on more than 400 food and beverage items, including safe cooking recommendations for meat, poultry and seafood products.

The app provides information on how to store food and beverages to maximize their freshness and quality. This will help keep products fresh longer than if they were stored improperly, which can happen more often during hot summer days. The application is available for free on Android and Apple devices.

Due to a variety of factors, including warmer temperatures, foodborne illness increases in summer. To help Americans stay healthy and safe, USDA offers the following food safety recommendations.

Bringing food to a picnic or cookout:
• Use an insulated cooler filled with ice or frozen gel packs. Frozen food can also be used as a cold source.
• Foods that need to be kept cold include raw meat, poultry, and seafood; deli and luncheon meats or sandwiches; summer salads (tuna, chicken, egg, pasta, or seafood); cut up fruit and vegetables; and perishable dairy products.
• A full cooler will maintain its cold temperature longer than a partially filled one. When using a cooler, keep it out of the direct sun by placing it in the shade or shelter.
• Avoid opening the cooler repeatedly so that your food stays colder longer.
Cooking on the grill:
• Use separate cutting boards and utensils for raw meat and ready-to-eat items like vegetables or bread.
• Keep perishable food cold until it is ready to cook.
• Use a food thermometer to make sure meat and poultry are cooked thoroughly to their safe minimum internal temperatures
• Beef, Pork, Lamb, & Veal (steaks, roasts, and chops): 145 °F with a 3 minute rest time
• Ground meats: 160 °F
• Whole poultry, poultry breasts, & ground poultry: 165 °F
• Always use a fresh, clean plate and tongs for serving cooked food. Never reuse items that touched raw meat or poultry to serve the food once it is cooked.
Serving food outdoors:
• Perishable food should not sit out for more than two hours. In hot weather (above 90 °F), food should NEVER sit out for more than one hour.
• Serve cold food in small portions, and keep the rest in the cooler. After cooking meat and poultry on the grill, keep it hot until served – at 140 °F or warmer.
• Keep hot food hot by setting it to the side of the grill rack, not directly over the coals where they could overcook.

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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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