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 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.
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:
- Online reporting form at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
- Get Form FDA 3500B, and either fax or mail it using the information on the form:
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:
Report if you suspect that the death was an outcome of the adverse event, and include the date if known.
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.
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