Category Archives: Keeping Kids Healthy

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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Triclosan And Your Child’s Well-being

A hand sanitizer, or antiseptic,  is often used as an alternative to hand washing when soap and water is not readily available. But not all hand sanitizers are created equal, and some may even cause health issues in children and adults.

Practicing good hand hygiene is especially important:wash_hands

After using the bathroom
Before eating or drinking anything
Before and after handling raw foods, fish, poultry, or eggs
After using a public phone
After riding public transportation
In schools and day care centers
After changing diapers
When one is sick
After shaking hands
After sneezing or coughing
After touching an ATM, elevator buttons or escalator handrails

Manufactures claim that sanitizers kill 99.9 percent of germs. But some studies suggest that keeping environments too clean and the persistent use of antibacterial soaps and hand sanitizers may inhibit proper immune system development in children. This is because inflammatory systems require the exposure to common germs to properly develop.

Although the FDA recommends, that when possible, it is better to use soap and water and scrub for at least 20 seconds, that is not always possible in the real world.

So what about hand sanitizers, and can they be dangerous?

There are new studies just out that are claiming that one ingredient used by some manufactures can indeed cause health issues. The ingredient is Triclosan.

Triclosan was first registered as a pesticide in 1969.

Triclosan is an antimicrobial active ingredient contained in a variety of products where it acts to slow or stop the growth of bacteria, fungi, and mildew. It is used in items such as conveyor belts, fire hoses, dye bath vats, or ice-making equipment as an antimicrobial pesticide.

brushteeth2Triclosan is also used in products such as, fabrics, vinyl, plastics (toys, toothbrushes), adhesives, polyethylene, polyurethane, polypropylene, floor wax emulsions, textiles (footwear, clothing), caulking compounds, sealants, rubber, carpeting, and a wide variety of other products.

Triclosan has been used since 1972, and it is present in soaps (0.10-1.00%), deodorants, toothpastes, mouth washes, and cleaning supplies, and is infused in an increasing number of consumer products such as kitchen utensils, toys, bedding, socks, and trash bags.bathing

So your morning routine may start with bathing or showering with soap, brushing your teeth with toothpaste and using mouth wash, perhaps applying some cosmetics, and a dash of deodorant. Then throughout the day, to protect yourself from germs, you use a pocket hand sanitizer, or spray.

Have you checked those items for Triclosan? If the product contains Triclosan, it must be labled.

ingredient_tricolsanSeveral scientific studies have come out since the last time the FDA reviewed Triclosan that warrant further review. According to one recent study, Triclosan may impact respiratory health, by promoting the development of allergies and causing inflammation in the mucous lining of the nose, also known as rhinitis.

Researchers from NIEHS, Norway, and the CDC found the link after measuring levels of Triclosan in urine samples from Norwegian children. The authors published their paper online Nov. 12 in the journal Allergy, and state their findings replicate those of another study that used American children participating in the National Health and Nutrition Examination Survey. Since these reports found an association between Triclosan and the occurrence of allergic sensitization in two different populations, the researchers feel confident the relationship is genuine.

The 623 Norwegian children used in the study have been followed since birth. At age 10, the youngsters received two days of extensive clinical evaluation at Oslo University Hospital, undergoing allergy skin prick tests and lung function assessments on a treadmill, and provided urine and blood samples. The research team sent the urine samples to the Centers for Disease Control and Prevention to measure the amounts of Triclosan.

The results showed that children with allergy sensitivity and rhinitis had the highest levels of Triclosan in their urine. Since Triclosan doesn’t stay in the body very long, 1-2 days according to the study, they think the elevated levels come from continued use of certain products.

Animal studies have shown that Triclosan alters hormone regulation. Other studies in bacteria have raised the possibility that triclosan contributes to making bacteria resistant to antibiotics.

The authors of the study plan to continue examining the Triclosan-allergy connection. They say other research groups have measured Triclosan in breast milk from Swedish mothers and, since Norwegian mothers tend to breastfeed their babies during the first 4-6 months of life, the study plans to follow up the Swedish findings with a study of Triclosan andbreastfeeding allergy development in Norwegian infants. The research team has already collected urine from the newborns and will follow up as they age.

The FDA has partnered with other Federal Agencies to study the effects of Triclosan on animal and environmental health.

So what to do?

Check the labels for Triclosan on the items you and your children use.

Many hand sanitizers, like the PURELL® brand, do not contain Triclosan. Using alcohol based instant hand sanitizers, when soap and water are not available, is one of the Centers for Disease Control and Prevention’s recommendations.

The Centers for Disease Control and Prevention have recommended the use of alcohol-based hand sanitizers when soap and water are not available and hands are not visibly dirty. The CDC recommends that children in school may use alcohol-based hand rubs as an alternative to handwashing.

The main active ingredient in Purell hand sanitizers is ethyl alcohol, the primary germ-killing agent in most hand-sanitizing agents.

According to the Purell company, one of the major benefits of using ethyl alcohol over other germ killing agents is that bacteria have been unable to create a resistance to ethyl alcohol. That means that regardless of how often you use the handsanitizer_purellproduct, the bacteria continue to die.

Other Ingredients Include:

Isopropyl alcohol is also a germ-killing agent. Although the percentage of isopropyl alcohol is much less than ethyl alcohol, both work together to keep your hands free of the bacteria and viruses that cause infection and disease.

Carbomer is a common ingredient used to make gel-like solutions. The carbomer is added to water in Purell by sifting it in. As the carbomer combines with the water, it creates a non-foaming gel.

Tocopheryl acetate is a form of the fat-soluble vitamin E. It is commonly used in skin products as an antioxidant and moisturizer. Its moisturizing properties can help offset the drying effect that ethyl alcohol can cause to the skin.

Glycerin is another common ingredient in skin products. It works in two ways–as a skin moisturizer that absorbs moisture from the air, and to make Purell easier to spread on the skin.

Propylene glycol is a moisturizer that works similar to glycerin. This ingredient pulls moisture from the air and deposits it into the upper layers of the skin, helping to keep skin from drying out.

Isopropyl myrisate works to thicken the consistency of the Purell gel. It also acts as an emollient to prevent the product from feeling oily.

Purell states that aboratory testing has never shown alcohol-based hand sanitizers like PURELL® to lead to bacterial resistance. “There is no evidence that organisms adapt and become immune to the active ingredient in PURELL® products. Once your hands are rubbed dry after application of PURELL®, the alcohol has evaporated completely. PURELL® leaves no harmful residue. A small bit of emollient (skin conditioning agent) is left on the hands after use to leave your hands feeling soft and refreshed.”

Non-alcohol, or some labeled ‘natural’ sanitizers are not as good. Alcohol-based sanitizers work because alcohol breaks up bacterial proteins and kills them.

In the end, know your ingredients, read labels, and choose wisely.

For those interested in trying Purell, here is a link to a coupon: http://www.purell.com/about-us/purell-coupons-promotions.aspx

Citations:
http://www.epa.gov/oppsrrd1/REDs/factsheets/triclosan_fs.htm;

http://www.epa.gov/endo/

Bertelsen RJ, Longnecker MP, Lovik M, Calafat AM, Carlsen KH, London SJ, Lodrup Carlsen KC. 2012. Triclosan exposure and allergic sensitization in Norwegian children. Allergy; doi:10.1111/all.12058 [Online 12 November 2012]

http://www.niehs.nih.gov/news/newsletter/2012/12/science-allergies/

http://www.livestrong.com/article/68666-purell-hand-sanitizer-ingredients/#ixzz2Ms7zvFfg

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