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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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Kids and Sunscreen (Infants)

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.”  infants_and_sunscreen

Sunscreens are recommended for children and adults. 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, explains Sachs. 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, Sachs says. If there’s 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. Sachs suggests testing your baby’s sensitivity to sunscreen by first trying a small amount on the inner wrist.

Cover Up

The American Academy of Pediatrics (AAP) suggests dressing 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, Sachs says. 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, says Sachs. The water content in both will help keep them well hydrated. A small of amount water in between these feedings is also okay.

sun_hat_baby

Make this oh-so-cute Sun Hat for Baby!

Here are some things to keep in mind this summer when outside with infants:

Keep your baby in the shade as much as possible. If you do use a small amount of sunscreen on your baby, don’t assume the child is well protected.

  • Make sure your child wears clothing that covers and protects sensitive skin. Use common sense; if you hold the fabric against your hand and it’s so sheer that you can see through it, it probably doesn’t offer enough protection.
  • Make sure your baby wears a hat that provides sufficient shade at all times.
  • Watch your baby carefully to make sure he or she doesn’t show warning signs of sunburn or dehydration. These include fussiness, redness and excessive crying.
  • Hydrate! Give your baby formula, breast milk, or a small amount of water between feedings if you’re out in the sun for more than a few minutes. Don’t forget to use a cooler to store the liquids.
  • Take note of how much your baby is urinating. If it’s less than usual, it may be a sign of dehydration, and that more fluids are needed until the flow is back to normal.
  • Avoid sunscreens containing the insect repellent DEET on infants, particularly on their hands. Young children may lick their hands or put them in their mouths. According to AAP, DEET should not be used on infants less than 2 months old.
  • If you do notice your baby is becoming sunburned, get out of the sun right away and apply cold compresses to the affected areas.
  • Make sure you talk with your pediatrician, or pharmacist if your baby is taking medications of any kind.  Sun and some Medications can cause bad interactions.
  • Never give an Infant or Child under the age of 19 aspirin, or use aspirin (salicylate) containing products as it could trigger Reye’s Syndrome, a deadly disease.

Related Information:

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Multiple Combination Medicines and Your Child

Know Active Ingredients in Children’s Meds

childrensdrugs

If your child is sneezing up a storm, it must be allergy season once more.

And if your child is taking more than one medication at the same time, there could be dangerous health consequences if those medicines have the same active ingredient, according to Hari Cheryl Sachs, M.D., a pediatrician at the Food and Drug Administration (FDA).

A medicine is made of many components. Some are “inactive” and only help it to taste better or dissolve faster, while others are active. An active ingredient in a medicine is the component that makes it pharmaceutically active—it makes the medicine effective against the illness or condition it is treating.

Active ingredients are listed first on a medicine’s Drug Facts label for over-the-counter (OTC) products. For prescription medicines, they are listed in a patient package insert or consumer information sheet provided by the pharmacist.

Many medicines have just one active ingredient. But combination medicines, such as those for allergy, cough, or fever and congestion, may have more than one.

Take antihistamines taken for allergies. “Too much antihistamine can cause sedation and—paradoxically—agitation. In rare cases, it can cause breathing problems, including decreased oxygen or increased carbon dioxide in the blood, Sachs says.

“We’re just starting allergy season,” says Sachs. “Many parents may be giving their children at least one product with an antihistamine in it.” Over-the-counter (OTC) antihistamines (with brand name examples) include diphenhydramine (Benadryl), chlorpheniramine (Chlor-Trimeton), clemastine (Tavist), fexofenadine (Allegra), loratadine (Claritin, Alavert), and cetirizine (Zyrtec).

multiple_combination_medicinesBut parents may also be treating their children for a separate ailment, such as a cough or cold. What they need to realize is that more than one combination medicine may be one too many.

“It’s important not to inadvertently give your child a double dose,” Sachs says.

Other Health Complications

The same goes for other active ingredients, often found in combination products for allergies but also used to treat other symptoms, such as fever, headache or nasal congestion:

  • Acetaminophen (in Tylenol and many other products), a pain reliever often used to treat fevers, mild pain or headache. Taking too much can cause liver damage.
  • Ibuprofen (for example, Advil or Motrin), another common medicine for relieving mild to moderate pain from headaches, sinus pressure, muscle aches and flu, as well as to reduce fever. Too much ibuprofen can cause nausea, vomiting, diarrhea, severe stomach pain, even kidney failure.
  • Decongestants such as pseudoephedrine or phenylephrine (found in brand name drugs such as Actifed and Sudafed) taken in large amounts can cause excessive drowsiness in children. They can also cause heart rhythm disturbances, especially if combined with products and foods containing caffeine. In the form of nasal sprays and nose drops, these products, as well as oxymetazoline (the active ingredients in products such as Afrin), can cause “rebound” congestion, in which the nose remains stuffy or gets even worse.

Never give a child aspirin or aspirin containing products, as you risk triggering Reye’s Syndrome, a deadly disease!

Any of the above symptoms may indicate a need for immediate medical attention. “The bottom line is that neither you, nor your children, should take multiple combination medicines at the same time without checking the active ingredients and consulting your health care professional first,” recommends Sachs.

Furthermore, two different active ingredients may serve the same purpose, Sachs says. For example, both acetaminophen and ibuprofen help reduce pain and fever. So there’s generally no need to give your child both medicines for the same symptoms.

Write It All Down

Whether you’re treating your child’s condition with OTC medicines from the drug store or ones prescribed by your doctor, it’s essential that you keep track of every medicine and the active ingredients each contains, Sachs says.

“It’s easy to forget which medicines you’re giving your child,” Sachs says. “And if you have more than one child, it can get even more complicated.” She recommends making it a habit to write down the name of any medicine you give your child, whether it’s OTC or prescription (download a daily medicine records template).

“It’s really a good idea to carry that list with you when you go to see your pediatrician or even when you go to the pharmacy,” she adds. You should also note whatever vitamins or supplements your child is taking, as these can interact unfavorably with certain medicines, too.

Most importantly, Sachs says parents should always read the Drug Facts label on OTC products, and the patient package insert or consumer information sheet that comes with prescription medicines, every time they’re considering a medication for their child, even if they think they already know the ingredients. They should know that the ingredients can change without an obvious change in the packaging. And they should contact their health care professional with any questions.

A list of ingredients to avoid, (other names for aspirin) can be downloaded here, or you can email the NRSF for a wallet size card(s) you can carry with you when shopping for medications.

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Grapefruit, Drug Interactions

Don’t take this with that! Seriesgrapefruit

Grapefruit causes problems when taken with certain medications

Sometimes the juice just isn’t worth the squeeze…especially when combining grapefruit with medicines.

While it can be part of a balanced and nutritious diet, grapefruit can have serious consequences when taken with certain medications. Currently, there are more than fifty prescription and over-the-counter drugs known to the U.S. Food and Drug Administration that can have negative interactions with grapefruit.

As little as one cup of juice or two grapefruit wedges can alter the way your medicines work. When taken with medicine, grapefruit can delay, decrease, or enhance absorption of certain drugs; as a result, the patient does not receive the prescribed dosage of the medication. If the label on your medicine reads “DO NOT TAKE WITH GRAPEFRUIT” or has similar words, heed the warning. It can save you a bushel of problems.

How it does or doesn’t work

pills

Depending on the active ingredient, grapefruit can reduce the effectiveness of a drug or worse, create potentially dangerous drug levels in the body. Grapefruit can interfere with transporters in the intestine that help absorb drugs. When this happens, less of the drug reaches the bloodstream and the patient receives no benefit.

Grapefruit can also interfere with enzymes that break down drugs in your digestive system. This can result in the body absorbing too much of the drug, which can potentially cause serious problems.

Help may be on the way

Scientists are currently working on breeding hybrid grapefruits that will be safe to mix with medications. In the near future you may be able to enjoy these tasty mounds without compromising your safety. But until the new fruit containers start to arrive, follow these tips:

  • Ask your pharmacist or other health care professional if you can have fresh grapefruit or grapefruit juice while using your medication. If you can’t, you may want to ask if you can have other juices with the medicine.
  • Read the Medication Guide or patient information sheet that comes with your prescription medicine to see if it interacts with grapefruit juice. Some information may advise not to take the drug with grapefruit juice. If it’s OK to have grapefruit juice, there will be no mention of it in the guide or information sheet.
  • Read the Drug Facts label on your non-prescription medicine, which will let you know if you can have grapefruit or other fruit juices with it.
  • If you can’t have grapefruit juice with your medicine, check the label of bottles of fruit juice or drinks flavored with fruit juice to make sure they don’t contain grapefruit juice.
  • Seville oranges (often used to make orange marmalade) and tangelos (a cross between tangerines and grapefruit) affect the same enzyme as grapefruit juice, so avoid these fruits as well if your medicine interacts with grapefruit juice.

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