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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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2012 Gratitude Report

2012 Gratitude Report

EDUCATION:

school nurseEvery year for the past 38 Years the National Reye’s Syndrome Foundation has provided life-saving Reye’s Syndrome information to the families of students in more than 136,000 schools across the United States and its Territories.

School Nurses and Administrators send a Reye’s Syndrome  packet of information home with each student at the beginning of every school year.  This packet includes Reye’s Syndrome Symptoms literature, bookmarks with NRSF contact information, wallet size ‘ingredients to avoid’ cards for Over-The-Counter children’s medications, a Reye’s Syndrome brochure, and a list of medicines that contain aspirin.

We know that this huge, educational initiative saves the lives of children all across the U.S. and we thank all school administrators and nurses for promoting Reye’s Syndrome Awareness!

VOLUNTEERS:

With the guidance of volunteer leaders from across the United States on our Board,  our RS survivors, and our caring community volunteers, the National Reye’s Syndrome Foundation  has stayed on mission for 38 years, educating and promoting awareness and saving lives.

We truly cherish your investment of time and money, and we count on your trust in our mission to eradicate the incidence of Reye’s Syndrome. The work we do at the NRSF is built on a solid foundation of financial accountability, transparency, and ethics.

And there is one more critically important element to our continued success. You. You are here to show us that there is a community of people who keep the mission of the National Reye’s Syndrome Foundation in their hearts each and every day.

bodNRSF’s All Volunteer Board of Directors

ACCOMPLISHMENTS:

A major milestone was achieved this year when talks between the NRSF, the FDA, and Bayer Consumer Health Care resulted in all aspirin manufacturers removing the words “baby aspirin” from all packaging and marketing.  For 37 years we fought for this life saving agreement and it finally came to fruition.  We know that this change will save many lives and we thank the FDA and the aspirin manufacturers for recognizing and acting upon this most serious issue.

This year, we have developed more technology to support our Awareness efforts; Android Apps, and E-books, promoting Reye’s Syndrome Awareness.  Our new apps; Aspirin Sense and Sensitivity, and A Guide to Chickenpox are both available in the google play store.

Our Reye’s Syndrome website is used by more than 150,000 people across the globe each month.  Visits always increase at the beginning of the school year, and during flu season. We are proud, and pleased to provide this quality information.

With the help of Transfer Me To DVD, located at www.TransferMeToDvd.com, all films and videos spanning our 38 year history have now been transferred to DVD for additional preservation.  We Thank them for donating so much of the work and supplies!

WITH YOUR SUPPORT:babyheart_right

  • 6,500 Emails answered this year.
  • 6,200 Phone Calls answered this year.
  • 136,000 Families Educated this year.
  • 1500 Reye’s Syndrome School Projects this year.

Several Major Dreams Came True this year:

  • Bayer removed all ‘baby’ aspirin packaging
  • NRSF goes to the SAG Awards
  • Millions of Young Lives Saved!

We invite you to join us in our work.  We invite you to donate toward our Awareness and Education programs.  We invite you to join the NRSF as a Member.

Thank You!

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84 % of Drugs, In Part or In Whole, Coming From China & India

What follows is a list of medicines made in China and or India.

The brand name equivalent, or brand name that the drug is sold as, is in parentheses.

Aciclovir – (Zovirax) – antiviral drug

Advair – asthma medicine

Adrenaline Hcl – treatment for cardiac arrest

Albendazole – treatment for worms

Alfuzosin – (Uroxatral) treatment for enlarged prostate

Allopurinol – gout treatment

Alprazolam – (Xanax) – treatment for anxiety disorders

Amikacin sulfate – treatment for bacterial infections

Aminophyline -treatment for cerebral ischemia

Amiodarone Hydrochloride -treatment for irregular heartbeat

Amlodipine – treats high blood pressure & angina

Ampicillin – antibiotic

Amodiaquine – treatment of malaria

Amoxicillin – antibiotic

Aniracetam – (Draganon, Sarpul, Ampamet) a congnition enhancer

Artemether – treats drug resistant malaria

Artesunate – malaria treatment

Aspirin – anti-inflammatory painkiller

Artemether – treats malaria

Atenolol – high blood pressure medicine

Atropine – antidote against nerve agents

Avandia – (Avandia) treatment of diabetes

Budesonide – (Entocort) treatment of allergy & asthma

Bupropion (Wellbutrin) antidepressant

Calcifediol – treats vitamin D deficiency

Candesartan – (Blopress, Atacand, Amias, Ratacand) treats hypertension

Captopril – (Capoten, Inhibace) treatment for hypertension & congestive heart failure

Carbamazepine – treatment of epilepsy, ADD & ADHD

Carnosine – treatment for autism

Cefixime – antibiotic

Cefotaxime – (Claforan) antibiotic

Cefsulodin – also, cephalosporin – antibiotic

Cephealexin – (Keflex, Keftab) – antibiotic

Chloramphenicol – antibiotic

Chlorpheniramine Maleate – (Chlor-Trimeton, Piriton) Antihistamine

Chlorpromazine Hydrochloride

Chloroquine Phosphate – treatment of malaria

Cilexetil – (Atacand) treats high blood pressure

Cilostazole – (Pletal) treats peripheral vascular disease

Cimetidine – (Tagamet) – heartburn treatment

Ciprofloxacine – (Cipro) – antibiotic & one of two effective treatments for anthrax exposure

Clomiphene Citrate – (Clomid, Serophene, Milophene) infertility treatment

Clopidogrel Bisulfate – (Plavix) treats coronary artery disease

Co-trimoxazole – (Septrin, Bactrim) antibiotic

Cloxacillin – antibiotic

Coreg – (Coreg) beta blocker that treats congestive heart failure

Cromoglicate – treats allergies and asthma

Cyclosporine – immunosuppressive drug

Cytisine – (Tabex) smoking cessation drug

Dexamethasone Acetate – anti-inflammatory steroid

Again, we can’t emphasize enough that you investigate, and understand the medicines you or your loved ones use.

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