Tag Archives: Parenting

Pepto Bismol and Children

The Pink Stuff – Harmless or Deadly…

Bismuth Sub-salicylate is a drug used to treat temporary discomforts of the stomach and gastrointestinal tract such as diarrhea, indigestion, heartburn and nausea. Commonly known as pink bismuth, it is the active ingredient in medications such as Pepto-Bismol and Kaopectate.

Bismuth subsalicylate is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.

But, in the gastrointestinal tract, Bismuth Sub-salicylate is converted to salicylic acid (aspirin) and insoluble bismuth harmless_or_deadly_find_outsalts.

There are adverse effects with this drug, most prominently; Reye’s Syndrome. It can also cause a black tongue and black stools in some users of the drug, when it combines with trace amounts of sulfur in saliva and the colon to form bismuth sulfide. Bismuth sulfide is a highly insoluble black salt, and the discoloration seen is temporary and and supposedly harmless.

Children should not take medication with bismuth subsalicylate because epidemiologic evidence points to an association between the use of salicylate-containing medications during viral infections and the onset of Reye’s Syndrome.

Never give a child under the age of 19 any product with aspirin when suffering from flu symptoms or a viral infection, including products like Pepto-Bismol or Kaopectate!

For the same reason, it is recommended that nursing mothers not use medication containing bismuth subsalicylate like Pepto-Bismol because small amounts of the medication are excreted in breast milk and pose a risk of triggering Reye’s Syndrome to nursing children.

pepto_burnedBismuth subsalicylate is the only active ingredient in an over the counter Drug that can leave a shiny metal oxide slag behind after being completely burnt with a blow torch.

 

 

 

Before you, as an adult, take bismuth subsalicylate:
— tell your doctor or pharmacist if you are allergic to salicylate pain relievers such as aspirin, choline magnesium trisalicylate, choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan’s, others), and salsalate (Argesic, Disalcid, Salgesic); or any other medication.

— tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to talk to your doctor or pharmacist about taking bismuth subsalicylate if you take: anticoagulants (‘blood thinners’) such as warfarin (Coumadin); a daily aspirin; or medication for diabetes, arthritis or gout.

— if you are taking tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Dynacin, Minocin), and tetracycline (Sumycin), take them at least 1 hour before or 3 hours after taking bismuth subsalicylate.

— ask your doctor before taking this medication if you have ever had an ulcer, bleeding problem, stools that are bloody or blackened, or kidney disease. Also ask your doctor before taking bismuth subsalicylate if you have a fever or mucus in your stool.

We never recommend giving bismuth subsalicylate to a child or teenager, but if you do, be sure to tell the child’s doctor if the child has any of the following symptoms before he or she receives the medication: vomiting, listlessness, drowsiness, confusion, aggression, seizures, yellowing of the skin or eyes, weakness, or flu-like symptoms. Also tell the child’s doctor if the child has not been drinking normally, has had excessive vomiting or diarrhea, or appears dehydrated.

— ask your doctor about taking this medication if you are pregnant or are breast-feeding.pepto_not_for_kids

Brand Names:
Bismusal®
Kaopectate®
Peptic Relief®
Pepto-Bismol®
Pink Bismuth®
Stomach Relief®

You can get a complete list of medications containing bismuth subsalicylate by clicking this link

Please think twice, and read the label warnings, before giving a child under the age of 19 any drugs that contain aspirin, salicylates, or bismuth-subsalicylate! You can get a list of ‘other names for aspirin’ here.

And always remember: Kids and Aspirin Products DON’T Mix!

Related Information:

Like this information?

donate_baby_angel

Click to Donate and Educate

Comments Off on Pepto Bismol and Children

Filed under Pepto Bismol and Children

Salicylate and Chemical Free Sunscreens

Whatever our skin color, we’re all potentially susceptible to sunburn and other harmful effects of exposure to UV radiation. Although we all need to take precautions to protect our skin, people who need to be especially careful in the sun are those who have

  • pale skin
  • blonde, red, or light brown hair
  • been treated for skin cancer
  • a family member who’s had skin cancer

If you take medicines, ask your health care professional about sun-care precautions; some medications may increase sun sensitivity.

We’ve created a great list of sunscreens that are salicylate (aspirin) and harmful chemical free.  Many use organic ingredients, and we’ve chosen the best of the best.  You can download the list by clicking here.

We caution you to always check the ingredients because manufacturers often make changes! fryday_2013

Please Note:

You’re at the beach, slathered in sunscreen. Your 5-month-old baby is there, too. Should you put sunscreen on her? Not usually, according to Hari Cheryl Sachs, M.D., a pediatrician at the Food and Drug Administration (FDA).

“The best approach is to keep infants under 6 months out of the sun,” Sachs says, “and to avoid exposure to the sun in the hours between 10 a.m. and 2 p.m., when ultraviolet (UV) rays are most intense.”

What makes babies so different?

For one thing, babies’ skin is much thinner than that of adults, and it absorbs the active, chemical ingredients in sunscreen more easily.  For another, infants have a high surface-area to body-weight ratio compared to older children and adults.  Both these factors mean that an infant’s exposure to the chemicals in sunscreens is much greater, increasing the risk of allergic reaction or inflammation.

The best protection is to keep your baby in the shade, if possible.  If there is no natural shade, create your own with an umbrella or the canopy of the stroller.

If there’s no way to keep an infant out of the sun, you can apply a small amount of sunscreen-with a sun protection factor (SPF) of at least 15-to small areas such as the cheeks and back of the hands. Test your baby’s sensitivity to sunscreen by first trying a small amount on the inner wrist.

Dress infants in lightweight long pants, long-sleeved shirts, and brimmed hats that shade the neck to prevent sunburn. Tight weaves are better than loose. Keep in mind that while baseball caps are cute, they don’t shade the neck and ears, sensitive areas for a baby.

Summer’s heat presents other challenges for babies.

Younger infants also don’t sweat like we do.  Sweat naturally cools the rest of us down when we’re hot, but babies haven’t yet fully developed that built-in heating-and-cooling system. So you want to make sure your baby doesn’t get overheated.

In the heat, babies are also at greater risk of becoming dehydrated. To make sure they’re adequately hydrated, offer them their usual feeding of breast milk or formula. The water content in both will help keep them well hydrated. A small of amount water in between these feedings is also okay.

For more information, go to:  https://reyessyndrome.wordpress.com/category/kids-and/kids-and-sunscreen/infants/

Other Resource Links:

Effectiveness of Sunscreen Products

Sunscreen: Children and Teens

Other Names for Aspirin

What Is Reye’s Syndrome

Like this information?

donate_baby_angel

Click to Donate and Educate

Comments Off on Salicylate and Chemical Free Sunscreens

Filed under Kids and Sunscreen, Salicylate & Chemical Free Sunscreens

May 24 is Don’t Fry Day!

Sun safety is never out of season. Summer’s arrival means it’s time for picnics, trips to the pool and beach—and a spike in fryday_2013the number of sunburns. But winter skiers and fall hikers should be as wary of the sun’s rays as swimmers. People who work outdoors need to take precautions, too.

The need for sun safety has become clearer over the past 30 years. Studies show that exposure to the sun can cause skin cancer. Harmful rays from the sun—and from sunlamps and tanning beds—may also cause eye problems, weaken your immune system, and give you skin spots, wrinkles, or “leathery” skin.

Sun damage to the body is caused by invisible ultraviolet (UV) radiation. People recognize sunburn as a type of skin damage caused by the sun. Tanning is also a sign of the skin reacting to potentially damaging UV radiation by producing additional pigmentation that provides it with some—but often not enough—protection against sunburn.

To remind everyone to protect their skin and health while enjoying the outdoors, the National Council on Skin Cancer Prevention (NCSCP) has designated May 25, 2012 as “Don’t Fry Day.” The Food and Drug Administration (FDA) and Environmental Protection Agency, advisory members of the council, are helping spread the word on sun safety.

Learn more about sun safety for your family in our Kids and Sunscreen blog area.

Download a free list of salicylate free, and chemical free sunscreens by clicking here.

And remember, never give a child under the age of 19 aspirin or aspirin products for sunburn pain, or for any pain, fever, or illness.  You could trigger a deadly disease known as Reye’s Syndrome.

 

Related Information:

Like this information?

donate_baby_angel

Click to Donate and Educate

 

Comments Off on May 24 is Don’t Fry Day!

Filed under Kids and Sunscreen, Salicylate & Chemical Free Sunscreens

Reporting Adverse Medical Effects

Reporting Adverse Reactions To Your Child’s Medications

Most pediatric clinical trials involve a relatively small number of patients, and problems might not be detected until the reporting_saves_lives products are in widespread use. And a drug or device might be studied in one pediatric age group, but prescribed and used in another age group in which it has not been studied, the FDA states.

Consumers can play a critical role in helping the Food and Drug Administration (FDA) assure children’s access to safe medical products.

Reporting to FDA such “adverse events” as unexpected, serious side effects, accidental exposure, and product quality issues can prompt the agency to act—and it can also bring new pediatric safety information to light.

In 2012, FDA received nearly 900,000 adverse event and medication error reports, but only 5 percent were associated with children under 18 years of age. Either parents or caregivers don’t know that they can report adverse effects to the FDA, or they don’t know how.

In 2007, the agency began receiving consumer accounts of serious side effects in children who were accidentally exposed to prescription topical testosterone gel products through contact with the skin of an adult male in their household who was using these products.

This information triggered an FDA investigation that resulted in stronger warning labels to alert the public. FDA also worked with testosterone gel product manufacturers to create potentially safer versions and to identify places on the body where the gel could be applied so that it is less likely to come into contact with children.

These reports from consumers made a big difference. the FDA found it extremely rewarding to work with those families who suspected that something might be going wrong and contacted FDA to investigate the situation. The FDA wants to prevent these harmful situations from happening to others and ensure medical products are safe for everyone to use.

What to Include:

Many adverse event reports do not include relevant information, such as the patient’s age, which can delay the identification of serious problems in children.

“The quality of reports is important,” says OSE director Gerald Dal Pan, M.D., M.H.S. “Document what is happening as much as possible. FDA needs the same kind of information as your health care provider to assess a potential problem with a medication.”

Consumers don’t have to prove that a medication or device caused the problem. “What I have found to be most helpful in reports from consumers is a clear statement about the event, followed by a more detailed description of what happened,” says Wyeth. FDA also recommends including information about:

  • Product name, type, dose, and how it was given (or administered);
  • How long the product was used;
  • Age of the child;
  • Other medications or medical conditions present at the time of event;
  • Outcome (such as what happened to the child if the medical product was stopped); and
  • Contact information for the person submitting the report and for the child’s health care professional.

Consumers often have the most details about what they are experiencing and should contact their health care provider for medical care, and then report the problem to the FDA.

What Happens to the Report

Each report is stored in a database monitored by FDA staff, who evaluate the reports, consult with medical staff and the manufacturer, and determine if more study is needed. There is a wide range of ways for FDA to communicate new safety information to the public, including warnings in the product label, patient monitoring recommendations, dosage adjustments for certain patients, medication guide updates, special programs like registries, and product withdrawal. (Medication guides are paper handouts given with certain medications by the pharmacist.)

FDA’s Pediatric Advisory Committee, a group of outside experts, meets two to three times a year to review adverse events for products recently labeled for use in children. Reviews for 215 products have been presented to the committee through September 2012. OPT maintains a Safety Reporting Page with information on products that the advisory committee has evaluated.

report_adverse_effects_to_fdaHow to Submit a Report:

Consumers should report serious side effects or product quality problems to FDA’s MedWatch: The FDA Safety Information and Adverse Event Reporting program.

There are three routes available to submit voluntary adverse event reports to the FDA:

You can also choose to print the blank form, fill out by hand, and submit

  • Call FDA at 1-800-FDA-1088 to report by telephone

Report Adverse Vaccine Events at: https://vaers.hhs.gov/esub/step1

Related Information for Consumers:

Report suspected unlawful sale of medical products on the Internet at: http://www.accessdata.fda.gov/scripts/email/oc/buyonline/buyonlineform.cfm

If you need information or if you have questions or comments about a medical product, please call the FDA’s toll-free information line, 1-888-INFO-FDA (1-888-463-6332) Press 2, followed by 1 for information, then:
for dietary supplements, select 2
for drug products, select 3
for medical devices, select 4
for biologics, including human cells, tissues, and cellular and tissue-based products, select 6

You will receive an acknowledgement from FDA when your report is received. Reports are reviewed by FDA staff. You will be personally contacted only if we need additional information.

What is a Serious Adverse Event?
An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is:

Death
Report if you suspect that the death was an outcome of the adverse event, and include the date if known.

Life-threatening
Report if suspected that the patient was at substantial risk of dying at the time of the adverse event, or use or continued use of the device or other medical product might have resulted in the death of the patient.

Hospitalization (initial or prolonged)
Report if admission to the hospital or prolongation of hospitalization was a result of the adverse event.

Emergency room visits that do not result in admission to the hospital should be evaluated for one of the other serious outcomes (e.g., life-threatening; required intervention to prevent permanent impairment or damage; other serious medically important event).

Disability or Permanent Damage
Report if the adverse event resulted in a substantial disruption of a person’s ability to conduct normal life functions, i.e., the adverse event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the patient’s body function/structure, physical activities and/or quality of life.

Congenital Anomaly/Birth Defect
Report if you suspect that exposure to a medical product prior to conception or during pregnancy may have resulted in an adverse outcome in the child.

Required Intervention to Prevent Permanent Impairment or Damage (Devices)
Report if you believe that medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, either situation suspected to be due to the use of a medical product.

Other Serious (Important Medical Events)
Report when the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical or surgical intervention (treatment) to prevent one of the other outcomes. Examples include allergic brochospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization. The development of drug dependence or drug abuse would also be examples of important medical events.

Related Information:

What Is Reye’s Syndrome

After Giving a Child Aspirin

Aspirin Containing Products

Other Names for Aspirin

Fraudulent Flu Products

Herbal Remedies

Kids And OTC Medicines

OTC Medicines Kids Should NOT Take

Multiple Combination Meds and Your Child

Like this information?

donate_baby_angel

Click to Donate and Educate

Comments Off on Reporting Adverse Medical Effects

Filed under Reporting Adverse Medical Effects

Kids and OTC Medicines Kids Should NOT Take!

FDA Statement: “Aside from drugs for fever or pain, most over-the-counter products haven’t actually been studied in children for effectiveness, safety, or dosing.”

In a recent poll conducted by University of Michigan C.S. Mott Children’s Hospital, 40 percent of parents are giving some_drugs_are_not_for_childrenchildren under the age of 4 over the counter cold medicines, even after the FDA issued a warning that OTC medicines should not be used in this age group.  Twenty Five percent of these parents gave their child decongestants!

Manufacturers of OTC cold medicines changed their warning labels in 2008 to reflect the dangers of giving these medicines to young children, Six years of age and under.

One of the problems is that the medicines themselves are still labeled “Children’s” medication, and just like the issue with “Baby” aspirin, parents don’t think to read the label and they assume the product is safe for all children when in fact, it is not.

(Currently, there is no longer a product packaged or marketed as “baby aspirin” because in 2011, the National Reye’s Syndrome Foundation met with the FDA, stressing the danger in using the term “baby” in representing low-dose aspirin. FDA and aspirin manufacturers agreed, and there is no such thing as ‘baby’ aspirin anymore, and children are safer because of this change.)

The side effects from use of cough and cold medicines in young children may include:

  • allergic reactions
  • increased or uneven heart rate
  • drowsiness or sleeplessness
  • slow and shallow breathing
  • confusion or hallucinations
  • convulsions
  • nausea
  • constipation.

“Products like these may work for adults, and parents think it could help their children as well. But what’s good for adults is not always good for children,” says Dr Matthew Davis, Director of the C.S. Mott Children’s Hospital National Poll on Children’s Health.

READ. THE. LABEL.learn_to_read_labels

OTC drugs have information on the bottle or box. Always read this information before using the medicine. This information tells you:

How much to give; Medication doses for infants and young children are based on age and weight. Know your child’s weight.

Follow the directions for age and weight. If the recommended age is not your child’s age, don’t give the medicine.

If no dose is given on the bottle or package for children under 12 years old, ask your doctor or pharmacist if it is OK to give the medicine to your child, how much you should give, and when you should give it.

Liquid medicines usually come with a cup, spoon or syringe to help measure the right dose. Always use these devices to give medicine to infants and very young children. Using a kitchen teaspoon is not an accurate way to measure. A teaspoon is usually considered to be 5 cc or 5 mL, but kitchen teaspoons can vary in size from between 2 mL and 10 mL.

If you want to mix medicine with milk or formula, first put the medicine in one ounce of milk and have the child drink it all. Then feed the remaining formula or milk in the bottle and let them finish however much more they want.

Always measure or give medication with a good light turned on. Insufficient light could cause you to give the wrong medicine or the wrong dose.

Never let young children take medicine by themselves.

How often to give Medicines; Some medicines state every 6 hours, or every 8 hours. Does this mean ‘waking’ hours; hours when the child is awake, or actual hours as around the clock? Ask your Pharmacist this question so you know exactly when to give your child the medicine. Then keep track of the times you give the medicine to your child on a chart tapped to your refridgerator, or the location the medication is stored.

What the drug contains – Be certain you are not double dosing your child!

Many OTC cough and cold medicines contain a combination of ingredients to treat several symptoms. Your child might be getting some of the same ingredients in other medicines. For example, Tylenol and Nyquil contain the same ingredient, acetaminophen. Be sure to read the list of active ingredients (the ingredients that make the medicine work) for each OTC medicine you give your child to make sure he or she is not getting a double dose of the same medication. You need to make sure that the total amount of a medicine does not exceed the recommended dose.

Combinations of medicines found in multi-symptom medicines may cause side effects in children. The combination of antihistamines and decongestants in some “cold remedy” medicines can have side effects such as hyperactivity, sleeplessness and irritability in children. To be safe, don’t combine prescriptions, supplements or multi-symptom medicines without checking with your health care provider or pharmacist.

Watch The Ingredients List:

Sometimes the ingredients for a medicine change but the name stays the same. For example, the formulation of Kaopectate, an OTC medicine for diarrhea, changed so it now contains bismuth subsalicylate. The older versions contained only kaolin and pectin. (Bismuth subsalicylate is also found in Pepto-Bismol, an OTC medicine for upset stomach and diarrhea.) Bismuth subsalicylate is NOT recommended for children younger than 19 because of the risk of the rare but deadly condition; Reye’s Syndrome.

Because of Reye’s syndrome, DO NOT give a child younger than 19 any product with aspirin or similar drugs called “salicylates” unless your doctor tells you to. Instead of aspirin or other salicylates, you can give your child acetaminophen (sold as Tylenol and other brands). There are many names for aspirin (salicylates) and you can see the list here: https://reyessyndrome.wordpress.com/2012/12/30/other-names-for-aspirin/

Be sure to take into consideration the concentrations of ingredients when you determine the amount you give your child. Medicines with the same brand name can be sold in different strengths, including infant, children and adult formulas. Infant drops of some medicines, for example, are stronger than the liquid elixir of the same medicine for toddlers or children. This is because infants may not be able to drink a large volume of medicine to give their proper dosage. Don’t make the mistake of giving higher doses of the infant drops to a toddler thinking the drops are not as strong.

Warnings about using the drug: Always Read the ‘Black Box’ – the warnings box!

If the drug is safe for children of certain ages: If your child’s age is not listed, do not use the product. One exception to age, is the Reye’s Syndrome warning on labels: The National Reye’s Syndrome Foundation collects Case Reports of Reye’s Syndrome and has found that Reye’s predominately attacks children up to the age of 19, whereas the FDA label only states age 12. Don’t use aspirin or aspirin containing products in children under the age of 19.

And if you are not sure – Ask the Pharmacist at the store. They will be happy to help you!

Other Tips:

Talk to your doctor, pharmacist, or nurse to find out what mixes well and what doesn’t. Medicines, vitamins, supplements, foods and beverages don’t always mix well with one another. Select products with the fewest number of ingredients needed to treat your symptoms.

Talk to your Doctor or Pharmacist before giving a child a ‘home remedy’, or homeopathic drug found on the Internet!  Many of these are quite harmful, and have no professional approval to use.  Know what you are giving your child, otherwise, it could be deadly!

Don’t call medications “candy.” If children come upon medications at a later time, they may consider it “candy” and eat it without your knowing.

Always use child-resistant caps and store medicines in a safe place. Relock the cap after each use. Be especially careful with any products that contain iron; they are the leading cause of poisoning deaths in young children. All medications become less effective (expire) over time and should be replaced. Check the expiration date before using any product.

Store medicines in a cool, dry area. The heat from kitchens and the moisture from bathrooms decrease the effectiveness of medications.  Store all medications out of the reach of children.

Before you give a medicine, check the outside packaging for damage such as cuts, slices, or tears; check the label on the download_free_medication_chartinside package to be sure you have the right medicine. Make sure the lid and seal are not broken. Check the color, shape, size and smell of the medicine. If you notice anything different or unusual, talk to a pharmacist or your health care provider.

Use a chart to keep track of dosage dates and times.  A Free Chart can be downloaded by clicking here.

Classes of OTC Medicines

Analgesics treat pain and fever:

Use caution with different forms of these drugs, because some are more concentrated than others. Common analgesics for infants and children are acetaminophen (Tylenol) and ibuprofen (Advil and Motrin).

WARNINGS:

  • DO NOT give aspirin to children younger than 19, because it can cause a rare but deadly disease called Reye’s Syndrome.
  • DO NOT use ibuprofen in children younger than 6 months. Know how much your child weighs before giving ibuprofen.

Antihistamines treat runny noses, itchy eyes and sneezing caused by allergies (but not colds). Some can cause sleepiness. Examples of antihistamines include brompheniramine (often in combination with decongestants such as phenylephrine as in Dimetapp and other medicines); chlorpheniramine (Chlor-Trimeton and other medicines); diphenhydramine (Benadryl and other medicines); cetrizine (Zyrtec); and loratadine (Claritin and other medicines).

WARNINGS:

  • These are not recommended for children younger than 6, because they can even affect learning.
  • Use only with your health care provider’s advice in young infants or children with asthma.

Expectorants and combination cough medications may help loosen mucus. Cough suppressants numb the reflex to cough. Coughing is necessary to clear mucus and debris bacteria from the lungs, so check with your child’s health care provider before using cough-suppressing syrups. Guaifenesin, an expectorant, promotes the production of thin mucus that is more easily removed by coughing.

WARNINGS:

  • These are not recomended for children under the age of 6.

Decongestants can relieve stuffiness caused by allergies or colds by temporarily shrinking the membranes in the nose to make breathing easier. They should not be used for more than two to three consecutive days. Decongestants taken by mouth can have a number of side effects such as irritability, sleeplessness, dizziness. Examples of decongestants include phenylephrine (found in Neo-Synephrine nose drops and other medicines); and pseudoephedrine (Sudafed, PediaCare Infant Decongestant Drops and other medicines).

WARNINGS:

  • These are not recommended for children under the age of 6.

Medicines for diarrhea. These are usually not necessary. Instead, give your child plenty of fluids and let the disease run its course. Diarrhea, however, can be dangerous in newborns and infants. In small children, severe diarrhea lasting just a day or two can lead to dehydration. Because a child can die from dehydration within a few days, you should see a health care provider as soon as possible if an infant has diarrhea. Talk to your provider before giving these medicines to infants or children.

WARNINGS:

  • Diarrhea medicines containing bismuth subsalicylate (Pepto-Bismol, Kaopectate, and other medicines) should NOT be given to a child younger than 19, as these could trigger Reye’s Syndrome, a deadly disease in children.
  • Loperamide (Imodium and other medicines), should NOT be given to a child younger than 6.

Laxatives relieve constipation and work by several methods. Some add fiber or water to stool to make it more bulky and easier for intestines to eliminate it; some coat the surface of the stool to make it more slippery; some soften the stool so it passes more easily; and others cause the intestines to contract more forcefully. Examples of laxatives include glycerin suppositories; magnesium citrate; magnesium hydroxide (Milk of Magnesia and other medicines); mineral oil (Agoral, Kondremul and other medicines); psyllium (Metamucil, Fiberall and other medicines); senna (Senokot, Ex-Lax and other medicines); methylcellulose (Citrucel and others), castor oil, and sodium phosphate (Fleet and other medicines).

WARNINGS:

  • DO NOT give infants or children laxatives without talking to your child’s health care provider.

Summary:
Aside from drugs for fever or pain, most over-the-counter products haven’t actually been studied in children for effectiveness, safety, or dosing.

  • When you give medicine to your child, be sure you’re giving the right medicine and the right amount.
  • Read and follow the label directions.
  • Use the correct dosing device. If the label says two teaspoons and you’re using a dosing cup with ounces only, don’t guess. Get the proper measuring device. Don’t substitute another item, such as a kitchen spoon.
  • Talk to your doctor, pharmacist, or other health care provider before giving two medicines at the same time. That way, you can avoid a possible overdose or an unwanted interaction.
  • Follow age and weight limit recommendations. If the label says don’t give to children under a certain age or weight, don’t do it.

Resources:
National Reye’s Syndrome Foundation, Food and Drug Administration, CDC, National Institutes of Health

Related Information:
What Is Reye’s Syndrome
Aspirin and Reye’s Syndrome
Other Names for Aspirin
Teens & Aspirin
Chicken Pox Parties
Herbal Remedies

Like this information?

donate_baby_angel

Click to Donate and Educate

Comments Off on Kids and OTC Medicines Kids Should NOT Take!

Filed under Kids and OTC Medicines

Effectiveness of Sunscreen Products

On June 14, 2011 the U.S. Food and Drug Administration (FDA) announced new requirements for sunscreens currently sold over-the-counter (OTC) (i.e. non-prescription). These requirements support the Agency’s ongoing efforts to ensure that sunscreens meet modern-day standards for safety and effectiveness.

sunscreen_broad_spectrumPrior rules on sunscreens dealt almost exclusively with protection against sunburn, which is primarily caused by ultraviolet B (UVB) radiation from the sun, and did not address ultraviolet A (UVA) radiation, which contributes to skin cancer and early skin aging. After reviewing the latest science, FDA determined that sufficient data are available to establish a “broad spectrum” test for determining a sunscreen product’s UVA protection. Passing the broad spectrum test shows that the product provides UVA protection that is proportional to its UVB protection.

Sunscreen products that pass the broad spectrum test are allowed to be labeled as “Broad Spectrum.” These “Broad Spectrum” sunscreens protect against both UVA and UVB rays. Scientific data demonstrated that products that are “Broad Spectrum SPF 15 [or higher]” have been shown to reduce the risk of skin cancer and early skin aging when used with other sun protection measures, in addition to helping prevent sunburn. Other sun protection measures include limiting time in the sun and wearing protective clothing.

These measures are necessary, says Lydia Velazquez, PharmD, in FDA’s Division of Nonprescription Regulation Development, because “our scientific understanding has grown. We want consumers to understand that not all sunscreens are created equal.”

“This new information will help consumers know which products offer the best protection from the harmful rays of the sun,” Velazquez says.  “It is important for consumers to read the entire label, both front and back, in order to choose the appropriate sunscreen for their needs.”

Everyone is potentially susceptible to sunburn and the other detrimental effects of exposure to UV radiation.

Products that pass the broad spectrum test will provide protection against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA).  Sunburn is primarily caused by UVB.  Both UVB and UVA can cause sunburn, skin cancer, and premature skin aging.  A certain percentage of a broad spectrum product’s total protection is against UVA.

Under the new regulations, sunscreen products that protect against all types of sun-induced skin damage will be labeled “Broad Spectrum” and “SPF 15” (or higher) on the front.

The new labeling will also tell consumers on the back of the product that sunscreens labeled as both “Broad Spectrum” and “SPF 15” (or higher) not only protect against sunburn, but, if used as directed with other sun protection measures, can reduce the risk of skin cancer and early skin aging. For these broad spectrum products, higher SPF (Sun Protection Factor) values also indicate higher levels of overall protection.

By contrast, any sunscreen not labeled as “Broad Spectrum” or that has an SPF value between 2 and 14, has only been shown to help prevent sunburn.

In addition to the final regulations, in June 2011 FDA proposed a regulation that would require sunscreen products that have SPF values higher than 50 to be labeled as “SPF 50+.” FDA does not have adequate data demonstrating that products with SPF values higher than 50 provide additional protection compared to products with SPF values of 50.

FDA also requested data and information on different dosage forms of sunscreen products.  The agency currently considers sunscreens in the form of oils, creams, lotions, gels, butters, pastes, ointments, sticks, and sprays to be eligible for potential inclusion in the OTC sunscreen monograph – meaning that they can be marketed without individual product approvals.

The agency currently considers wipes, towelettes, powders, body washes, and shampoo not eligible for the monograph. Therefore, they cannot be marketed without an approved application.

For sunscreen spray products, the agency requested additional data to establish effectiveness and to determine whether they present a safety concern if inhaled unintentionally.  These requests arose because sprays are applied differently from other sunscreen dosage forms, such as lotions and sticks.

In addition, FDA issued a draft guidance to help sunscreen manufacturers understand how to label and test their products in light of the final and proposed regulations and the data request on dosage forms.

Sun Safety Tips

Spending time in the sun increases the risk of skin cancer and early skin aging.  To reduce this risk, consumers should sun_plus_must_havesregularly use sun protection measures including:

  • Use sunscreens with broad spectrum SPF values of 15 or higher regularly and as directed.
  • Limit time in the sun, especially between the hours of 10 a.m. and 2 p.m., when the sun’s rays are most intense.
  • Wear clothing to cover skin exposed to the sun; for example, long-sleeved shirts, pants, sunglasses, and broad-brimmed hats.
  • Reapply sunscreen at least every 2 hours, more often if you’re sweating or jumping in and out of the water.
  • Hydrate!  Drink lots of water and good fluids! (Soda products will just make you more thirsty, so try homemade lemonade or iced tea, or just plain water.
  • Wear protective eye ware! Even children should wear real sunglasses with UV protection, not just those play sunglasses.

Located here, are a couple of helpful videos.

Related Information:

Like this information?

donate_baby_angel

Click to Donate and Educate

Comments Off on Effectiveness of Sunscreen Products

Filed under Kids and Sunscreen, Kids And...., Sunscreen Effectiveness

Sunscreen; Children & Teens

Sun safety is never out of season. Summer’s arrival means it’s time for picnics, trips to the pool and beach—and a spike in the number of sunburns. But winter skiers and fall hikers should be as wary of the sun’s rays as swimmers. People who work outdoors need to take precautions, too.

The need for sun safety has become clearer over the past 30 years. Studies show that exposure to the sun can cause skin cancer. Harmful rays from the sun—and from sunlamps and tanning beds—may also cause eye problems, weaken your immune system, and give you skin spots, wrinkles, or “leathery” skin.

Sun damage to the body is caused by invisible ultraviolet (UV) radiation. People recognize sunburn as a type of skin damage caused by the sun. Tanning is also a sign of the skin reacting to potentially damaging UV radiation by producing additional pigmentation that provides it with some—but often not enough—protection against sunburn.

Whatever our skin color, we’re all potentially susceptible to sunburn and other harmful effects of exposure to UV radiation. Although we all need to take precautions to protect our skin, people who need to be especially careful in the sun are those who have

  • pale skin
  • blond, red, or light brown hair
  • been treated for skin cancer
  • a family member who’s had skin cancer

If you take medicines, ask your health care professional about sun-care precautions; some medications may increase sun sensitivity.

Reduce Time in the Sun

It’s important to limit sun exposure between 10 a.m. and 2 p.m., when the sun’s rays are strongest. Even on an overcast day, up to 80 percent of the sun’s UV rays can get through the clouds. Stay in the shade as much as possible throughout the day.

Dress with Care

Wear clothes that protect your body. If you plan on being outside on a sunny day, cover as much of your body as smart_sun_sense_childrenpossible. Wear a wide-brimmed hat, long sleeves, and pants. Sun-protective clothing is now available. However, FDA only regulates such products if the manufacturer intends to make a medical claim. Consider using an umbrella for shade.

Be Serious about Sunscreen

Check product labels to make sure you get

  • a “sun protection factor” (SPF) of 15 or more. SPF represents the degree to which a sunscreen can protect the skin from sunburn.
  • “broad spectrum” protection—sunscreen that protects against all types of skin damage caused by sunlight
  • water resistance—sunscreen that stays on your skin longer, even if it gets wet. Reapply water-resistant sunscreens as instructed on the label.

Look For:  Active Ingredients: Zinc Oxide, Titanium Dioxide, Mexoryl SX, or Avobensone(3%)

Look For:  SPF of 15 to 50, depending on your skin tone and the sun’s intensity – being near or in the water, or taking a walk through a wooded park.

Look For:  Lotions, not sprays or powdered formulas – you have more control over coverage.

Look For:  A Water Resistant formula for the beach or swimming pool, or for boating.

Avoid:  Salicylates – Salicylates were first used in cosmetics as Benzyl salicylates. Currently octyl salicylate is the major salicylate component of sunscreen.  Salicylates protect against a small part of the UVB spectrum and must be used in high concentrations. They are aspirin-like substances.

With the increased use of sunscreens it is not surprising that there has been an increase in reports of adverse reactions to sunscreens.

Avoid: Vitamin A (retinyl palmitate) which causes skin cancer in laboratory tests.

Avoid: Oxybensone – a hormone disruptor and skin allergen

Avoid: High SPF’s – it is misleading and offers little additional benefits

Tips for Applying Sunscreen

  • Apply the recommended amount evenly to all uncovered skin, especially your lips, nose, ears, neck, hands, and feet.
  • Apply sunscreen 15 minutes before going out in the sun.
  • If you don’t have much hair, apply sunscreen to the top of your head, or wear a hat.
  • Reapply at least every two hours.
  • Give babies and children extra care in the sun. Ask a health care professional before applying sunscreen to children under 6 months old.
  • Apply sunscreen to children older than 6 months every time they go out.

Protect the Eyes

Sunlight reflecting off snow, sand, or water further increases exposure to UV radiation and increases your risk of developing eye problems.

Tips for eye-related sun safety include:

  • When buying sunglasses, look for a label that specifically offers 99 to 100 percent UV protection.childrens_sunglasses
  • Eye wear should be labeled “sunglasses.” Otherwise, you can’t be sure they will offer enough protection.
  • Pricier sunglasses don’t ensure greater UV protection.
  • Ask an eye care professional to test your sunglasses if you don’t know their level of UV protection.
  • People who wear contact lenses that offer UV protection should still wear sunglasses.
  • Wraparound sunglasses offer the most protection.
  • Children should wear real sunglasses (not toy sunglasses!) that indicate the UV protection level.

Never give a child up to the age of 19 aspirin or aspirin containing products because you could trigger a deadly disease known as Reye’s Syndrome.

Related Information:

Like this information?

donate_baby_angel

Click to Donate and Educate

Comments Off on Sunscreen; Children & Teens

Filed under Children and Teens, Kids and Sunscreen