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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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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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Beware Fraudulent Flu Products

In the past week, FDA has sent an additional nine warning letters to firms marketing fraudulent flu products, including flufraudredflagan online firm marketing an “alternative to the flu shot,” a firm selling an oral spray online and in major retail stores, and three firms marketing dietary supplements online. (The latter three firms’ letters are co-signed by the Federal Trade Commission, which regulates the advertising of many consumer products.)

The remaining four warning letters were issued to online firms selling what they claim to be generic and other unapproved versions of oseltamivir phosphate (the active ingredient in Tamiflu). Tamiflu is an FDA-approved brand-name drug; no generic is approved in the U.S.

As the flu continues to make people sick—and even cause deaths—scammers are alive and well, promoting their fraudulent products to the unsuspecting public.

These scammers sell their products with claims to prevent, treat or cure the flu, even though they have not been tested and the Food and Drug Administration (FDA) has not approved them.

FDA warns consumers to steer clear of fraudulent flu products, which can be found online and in retail stores and may include products marketed as dietary supplements or conventional foods, drugs, nasal sprays and devices.

“As any health threat emerges, fraudulent products appear almost overnight,” says Gary Coody, R.Ph., FDA’s national health fraud coordinator. “Right now, so-called ‘alternatives’ to the flu vaccine are big with scammers.”

“These unproven products give consumers a false sense of security,” says Mary Malarkey, director of FDA’s Office of Compliance and Biologics Quality. “There is no need to buy a product that claims to be an alternative to the vaccine. Flu vaccine is still available and it’s not too late to get vaccinated.”

Flu Fraud Red Flags!

These flu claims on an unapproved product indicate that it may be fraudulent:

  • reduces severity and length of flu
  • boosts your immunity naturally without a flu shot
  • safe and effective alternative to flu vaccine
  • prevents catching the flu
  • effective treatment for flu
  • faster recovery from flu
  • supports your body’s natural immune defenses to fight off flu

The best way to prevent the flu is by getting vaccinated every year, and the Centers for Disease Control and Prevention (CDC) recommends the vaccine for adults and children over six months of age. To find a list of clinics, supermarkets, pharmacies and other vaccine providers in your neighborhood, visit www.flu.gov, click on “Flu Vaccine Finder” and enter your zip code.

If you get the flu, two FDA-approved antiviral drugs—Tamiflu (oseltamivir) and Relenza (zanamivir)—are treatment options recommended by CDC. These prescription drugs can help fight the virus in your body and shorten the time you’re sick. They can also be used to help prevent the flu.

Types of Fraudulent Flu Products

There are no legally marketed over-the-counter (OTC) drugs to prevent or cure the flu. However, there are legal OTC products to reduce fever and to relieve muscle aches, congestion, and other symptoms typically associated with the flu.

NOTE: Never give aspirin or aspirin products to children under that age of 19 for flu or viral No Aspirin Products for Children!infections!

Unapproved drugs (which sometimes are marketed as dietary supplements), conventional foods (such as herbal teas) or devices (such as air filters and light therapies) are fraudulent if they make flu prevention, treatment or cure claims, says Coody, “because they haven’t been evaluated by FDA for these uses.”

On Jan. 25, 2013, FDA and the Federal Trade Commission jointly sent a warning letter to the company that markets “GermBullet,” a nasal inhaler that makes flu prevention and treatment claims. The firm is required to remove the language in its labeling and advertising that violates federal law.

“If the company continues to sell the product without removing the deceptive and illegal language, the firm may be subject to enforcement action, which could include seizure of the products or other legal sanctions,” says FDA Regulatory Counsel Brad Pace, J.D., of FDA’s Health Fraud and Consumer Outreach Branch.

Fraudulent Online Pharmacies

Online pharmacies present an opportunity for Internet scammers to take advantage of unsuspecting consumers. Legitimate online pharmacies do exist, but so do many websites that look like professional and legitimate pharmacies but are actually fraudulent and illegal.

These websites may be selling unapproved antiviral drugs. “Beware of websites that sell generic Tamiflu or Relenza,” says FDA pharmacist Connie Jung, R.Ph., Ph.D., of FDA’s Office of Drug Security, Integrity and Recalls. “Currently there are no FDA-approved generics available for these drugs on the U.S. market.”

“With unapproved products, you really don’t know what you’re getting and can’t be sure of the quality,” adds Jung. “The products could be counterfeit, contaminated, or have the wrong active ingredient or no active ingredient. You could experience a bad reaction, or not receive the drug you need to get better.”

Jung also warns consumers not to be tempted by an online seller that offers much lower prices than typically charged for prescription drugs by your local pharmacy. “Deep discounts on price are a good indicator of a fraudulent, illegal online pharmacy. You should avoid these online sellers because you might get products that are harmful to your health.”

FDA encourages consumers to buy prescription drugs only through an online pharmacy that requires a valid prescription from a doctor or other authorized health care provider and is licensed by the state board of pharmacy (or equivalent state agency) where the patient is located.

Health fraud is pervasive and it’s not always easy to spot a fraudulent product, says Coody. “If you’re tempted to buy an unproven or little known treatment, especially if it’s sold on the Internet, check with your health care provider first.”

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