Monthly Archives: May 2013

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

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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:

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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

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