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Neem & Margosa Oil

Margosa or Neem Oil

Margosa or Neem oil is a yellow oil with a disagreeable smell and bitter taste that has been used as a medical remedy in India and Southeast Asia for several centuries.  In recent years, there have been rare reports of acute onset of severe metabolic acidosis, hepatic and multiorgan failure and death following ingestion of margosa oil.

Background

Margosa oil is an extract of the seeds of Azadirachta indica, commonly known as the Neem tree native to India and

NOT FOR CHILDREN!!

NOT FOR CHILDREN!!

Sri Lanka.  In low doses, margosa oil has been a traditional remedy for centuries in India and Southeast Asia used in treating asthma, intestinal parasites, arthritis and leprosy.  It is also an insecticide.  The oil has a disagreeable smell and bitter taste attributable to volatile sulphur compounds and fatty acids.   The bitters are secondary products formed during storage of the oil or the seeds and concentrations can vary in different commercial samples.

Hepatotoxicity

Margosa oil can cause severe metabolic acidosis and death, particularly in young children.  Symptoms of nausea, vomiting and progressive stupor develop within hours of consumption, followed by severe metabolic acidosis, coma, and progressive hepatic dysfunction, similar to Reye Syndrome.  Serum aminotransferase levels are generally normal or minimally elevated initially, but then rise to high levels accompanied by increases in LDH and CPK levels.  Progressive hepatic encephalopathy and cerebral edema develop within days.   This product contains high levels of salicylates – the same as aspirin.  Therefore, this product could trigger Reye’s Syndrome and should not be given or used by children under the age of 19.

Again, we urge extreme caution in using herbal remedies, and always check for salicylates in any product given to children under the age of 19.

NOT FOR CHILDREN!

NOT FOR CHILDREN!

 

 

 

 

 

 

 

 

Mechanism of Injury

The mechanism of hepatotoxicity of margosa oil appears to be related to mitochondrial dysfunction and poisoning of the electron transport pathway by a component of margosa oil or a contaminant.  A similar syndrome has been induced in laboratory animals with samples of the implicated oil.

 Other Names:  Neem oil

Other links:

What is Reye’s Syndrome

Aspirin Containing Products

Other Names for Aspirin

Pepto-Bismol and Children

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Reye’s Syndrome Information; Caregiver Handout

Reye’s Syndrome doesn’t make news headlines anymore like it use to in the 1970’s and 1980’s.  That doesn’t mean it has gone away, though.  Thousands of children’s lives are spared from Reye’s today due to constant efforts to educate parents and caregivers about the dangers of aspirin-containing products and children.

However, here at the Foundation, the phones still ring, and email comes in, from frantic parents who discover that a grandparent, a babysitter, or other caregiver has given their child aspirin.  Some times, the calls are from young parents who gave their child an aspirin product and then read the label warning them not to.

It’s just a normal progression in life; people forget.  Especially the older we get.  The Reye’s epidemic of the 70’s and 80’s were 30 to 40 years ago.  It’s easy for grandparents to forget those terrifying times.  And, today, with the lowered incidence of Reye’s Syndrome, doctors don’t see cases, and Reye’s has quietly slipped out of mind.  Doctors tell parents some_drugs_are_not_for_childrennot to give a child aspirin, but does not warn about other aspirin-containing medications like Pepto-Bismol, a product containing bismuth-subsalicylate, also known to trigger Reye’s Syndrome in children.

To make it easier on parents, we have created a Reye’s Syndrome caregiver / babysitter handout you can download and give to anyone who is going to be with your child while you are away.

Tuck several copies into your diaper bag, or purse, keep copies in your car, download it to your phone, store it in your email, or in your Cloud Box, anywhere you can access it, print it, or email it to someone who will be providing care for your child.

Tack it to your refrigerator,  on the bathroom mirror, at your baby’s changing station, on the door to your medicine cabinet, next to your emergency numbers, anywhere your caregiver will notice it, and read it.  Before you leave, point it out, and have them read it over so they understand the seriousness of the issue.

Free Handout!

Free Handout!

Not only will you be protecting your own child in doing this, you will educate any child under the age of 19 who may be babysitting for you, that they too, are susceptible to Reye’s and should not be taking these products.

Another by-product of using this for any caregiver, is you alleviate any guilt or hard feelings with family and relatives who may have forgotten about Reye’s and who innocently thought they were doing the child some good by giving him an aspirin.

Guilt is a very difficult, and a huge issue for grandparents to live with – don’t put them through it – just give them a copy of this handout.

Download your copy, and send copies to other parents, or let them know where to get a copy.

 

 

Related Information:

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Salicylate and Chemical Free Sunscreens

Whatever our skin color, we’re all potentially susceptible to sunburn and other harmful effects of exposure to UV radiation. Although we all need to take precautions to protect our skin, people who need to be especially careful in the sun are those who have

  • pale skin
  • blonde, red, or light brown hair
  • been treated for skin cancer
  • a family member who’s had skin cancer

If you take medicines, ask your health care professional about sun-care precautions; some medications may increase sun sensitivity.

We’ve created a great list of sunscreens that are salicylate (aspirin) and harmful chemical free.  Many use organic ingredients, and we’ve chosen the best of the best.  You can download the list by clicking here.

We caution you to always check the ingredients because manufacturers often make changes! fryday_2013

Please Note:

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.”

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.  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.  If there is 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. Test your baby’s sensitivity to sunscreen by first trying a small amount on the inner wrist.

Dress 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.  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. The water content in both will help keep them well hydrated. A small of amount water in between these feedings is also okay.

For more information, go to:  https://reyessyndrome.wordpress.com/category/kids-and/kids-and-sunscreen/infants/

Other Resource Links:

Effectiveness of Sunscreen Products

Sunscreen: Children and Teens

Other Names for Aspirin

What Is Reye’s Syndrome

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May 24 is Don’t Fry Day!

Sun safety is never out of season. Summer’s arrival means it’s time for picnics, trips to the pool and beach—and a spike in fryday_2013the number of sunburns. But winter skiers and fall hikers should be as wary of the sun’s rays as swimmers. People who work outdoors need to take precautions, too.

The need for sun safety has become clearer over the past 30 years. Studies show that exposure to the sun can cause skin cancer. Harmful rays from the sun—and from sunlamps and tanning beds—may also cause eye problems, weaken your immune system, and give you skin spots, wrinkles, or “leathery” skin.

Sun damage to the body is caused by invisible ultraviolet (UV) radiation. People recognize sunburn as a type of skin damage caused by the sun. Tanning is also a sign of the skin reacting to potentially damaging UV radiation by producing additional pigmentation that provides it with some—but often not enough—protection against sunburn.

To remind everyone to protect their skin and health while enjoying the outdoors, the National Council on Skin Cancer Prevention (NCSCP) has designated May 25, 2012 as “Don’t Fry Day.” The Food and Drug Administration (FDA) and Environmental Protection Agency, advisory members of the council, are helping spread the word on sun safety.

Learn more about sun safety for your family in our Kids and Sunscreen blog area.

Download a free list of salicylate free, and chemical free sunscreens by clicking here.

And remember, never give a child under the age of 19 aspirin or aspirin products for sunburn pain, or for any pain, fever, or illness.  You could trigger a deadly disease known as Reye’s Syndrome.

 

Related Information:

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Kids and OTC Medicines Kids Should NOT Take!

FDA Statement: “Aside from drugs for fever or pain, most over-the-counter products haven’t actually been studied in children for effectiveness, safety, or dosing.”

In a recent poll conducted by University of Michigan C.S. Mott Children’s Hospital, 40 percent of parents are giving some_drugs_are_not_for_childrenchildren under the age of 4 over the counter cold medicines, even after the FDA issued a warning that OTC medicines should not be used in this age group.  Twenty Five percent of these parents gave their child decongestants!

Manufacturers of OTC cold medicines changed their warning labels in 2008 to reflect the dangers of giving these medicines to young children, Six years of age and under.

One of the problems is that the medicines themselves are still labeled “Children’s” medication, and just like the issue with “Baby” aspirin, parents don’t think to read the label and they assume the product is safe for all children when in fact, it is not.

(Currently, there is no longer a product packaged or marketed as “baby aspirin” because in 2011, the National Reye’s Syndrome Foundation met with the FDA, stressing the danger in using the term “baby” in representing low-dose aspirin. FDA and aspirin manufacturers agreed, and there is no such thing as ‘baby’ aspirin anymore, and children are safer because of this change.)

The side effects from use of cough and cold medicines in young children may include:

  • allergic reactions
  • increased or uneven heart rate
  • drowsiness or sleeplessness
  • slow and shallow breathing
  • confusion or hallucinations
  • convulsions
  • nausea
  • constipation.

“Products like these may work for adults, and parents think it could help their children as well. But what’s good for adults is not always good for children,” says Dr Matthew Davis, Director of the C.S. Mott Children’s Hospital National Poll on Children’s Health.

READ. THE. LABEL.learn_to_read_labels

OTC drugs have information on the bottle or box. Always read this information before using the medicine. This information tells you:

How much to give; Medication doses for infants and young children are based on age and weight. Know your child’s weight.

Follow the directions for age and weight. If the recommended age is not your child’s age, don’t give the medicine.

If no dose is given on the bottle or package for children under 12 years old, ask your doctor or pharmacist if it is OK to give the medicine to your child, how much you should give, and when you should give it.

Liquid medicines usually come with a cup, spoon or syringe to help measure the right dose. Always use these devices to give medicine to infants and very young children. Using a kitchen teaspoon is not an accurate way to measure. A teaspoon is usually considered to be 5 cc or 5 mL, but kitchen teaspoons can vary in size from between 2 mL and 10 mL.

If you want to mix medicine with milk or formula, first put the medicine in one ounce of milk and have the child drink it all. Then feed the remaining formula or milk in the bottle and let them finish however much more they want.

Always measure or give medication with a good light turned on. Insufficient light could cause you to give the wrong medicine or the wrong dose.

Never let young children take medicine by themselves.

How often to give Medicines; Some medicines state every 6 hours, or every 8 hours. Does this mean ‘waking’ hours; hours when the child is awake, or actual hours as around the clock? Ask your Pharmacist this question so you know exactly when to give your child the medicine. Then keep track of the times you give the medicine to your child on a chart tapped to your refridgerator, or the location the medication is stored.

What the drug contains – Be certain you are not double dosing your child!

Many OTC cough and cold medicines contain a combination of ingredients to treat several symptoms. Your child might be getting some of the same ingredients in other medicines. For example, Tylenol and Nyquil contain the same ingredient, acetaminophen. Be sure to read the list of active ingredients (the ingredients that make the medicine work) for each OTC medicine you give your child to make sure he or she is not getting a double dose of the same medication. You need to make sure that the total amount of a medicine does not exceed the recommended dose.

Combinations of medicines found in multi-symptom medicines may cause side effects in children. The combination of antihistamines and decongestants in some “cold remedy” medicines can have side effects such as hyperactivity, sleeplessness and irritability in children. To be safe, don’t combine prescriptions, supplements or multi-symptom medicines without checking with your health care provider or pharmacist.

Watch The Ingredients List:

Sometimes the ingredients for a medicine change but the name stays the same. For example, the formulation of Kaopectate, an OTC medicine for diarrhea, changed so it now contains bismuth subsalicylate. The older versions contained only kaolin and pectin. (Bismuth subsalicylate is also found in Pepto-Bismol, an OTC medicine for upset stomach and diarrhea.) Bismuth subsalicylate is NOT recommended for children younger than 19 because of the risk of the rare but deadly condition; Reye’s Syndrome.

Because of Reye’s syndrome, DO NOT give a child younger than 19 any product with aspirin or similar drugs called “salicylates” unless your doctor tells you to. Instead of aspirin or other salicylates, you can give your child acetaminophen (sold as Tylenol and other brands). There are many names for aspirin (salicylates) and you can see the list here: https://reyessyndrome.wordpress.com/2012/12/30/other-names-for-aspirin/

Be sure to take into consideration the concentrations of ingredients when you determine the amount you give your child. Medicines with the same brand name can be sold in different strengths, including infant, children and adult formulas. Infant drops of some medicines, for example, are stronger than the liquid elixir of the same medicine for toddlers or children. This is because infants may not be able to drink a large volume of medicine to give their proper dosage. Don’t make the mistake of giving higher doses of the infant drops to a toddler thinking the drops are not as strong.

Warnings about using the drug: Always Read the ‘Black Box’ – the warnings box!

If the drug is safe for children of certain ages: If your child’s age is not listed, do not use the product. One exception to age, is the Reye’s Syndrome warning on labels: The National Reye’s Syndrome Foundation collects Case Reports of Reye’s Syndrome and has found that Reye’s predominately attacks children up to the age of 19, whereas the FDA label only states age 12. Don’t use aspirin or aspirin containing products in children under the age of 19.

And if you are not sure – Ask the Pharmacist at the store. They will be happy to help you!

Other Tips:

Talk to your doctor, pharmacist, or nurse to find out what mixes well and what doesn’t. Medicines, vitamins, supplements, foods and beverages don’t always mix well with one another. Select products with the fewest number of ingredients needed to treat your symptoms.

Talk to your Doctor or Pharmacist before giving a child a ‘home remedy’, or homeopathic drug found on the Internet!  Many of these are quite harmful, and have no professional approval to use.  Know what you are giving your child, otherwise, it could be deadly!

Don’t call medications “candy.” If children come upon medications at a later time, they may consider it “candy” and eat it without your knowing.

Always use child-resistant caps and store medicines in a safe place. Relock the cap after each use. Be especially careful with any products that contain iron; they are the leading cause of poisoning deaths in young children. All medications become less effective (expire) over time and should be replaced. Check the expiration date before using any product.

Store medicines in a cool, dry area. The heat from kitchens and the moisture from bathrooms decrease the effectiveness of medications.  Store all medications out of the reach of children.

Before you give a medicine, check the outside packaging for damage such as cuts, slices, or tears; check the label on the download_free_medication_chartinside package to be sure you have the right medicine. Make sure the lid and seal are not broken. Check the color, shape, size and smell of the medicine. If you notice anything different or unusual, talk to a pharmacist or your health care provider.

Use a chart to keep track of dosage dates and times.  A Free Chart can be downloaded by clicking here.

Classes of OTC Medicines

Analgesics treat pain and fever:

Use caution with different forms of these drugs, because some are more concentrated than others. Common analgesics for infants and children are acetaminophen (Tylenol) and ibuprofen (Advil and Motrin).

WARNINGS:

  • DO NOT give aspirin to children younger than 19, because it can cause a rare but deadly disease called Reye’s Syndrome.
  • DO NOT use ibuprofen in children younger than 6 months. Know how much your child weighs before giving ibuprofen.

Antihistamines treat runny noses, itchy eyes and sneezing caused by allergies (but not colds). Some can cause sleepiness. Examples of antihistamines include brompheniramine (often in combination with decongestants such as phenylephrine as in Dimetapp and other medicines); chlorpheniramine (Chlor-Trimeton and other medicines); diphenhydramine (Benadryl and other medicines); cetrizine (Zyrtec); and loratadine (Claritin and other medicines).

WARNINGS:

  • These are not recommended for children younger than 6, because they can even affect learning.
  • Use only with your health care provider’s advice in young infants or children with asthma.

Expectorants and combination cough medications may help loosen mucus. Cough suppressants numb the reflex to cough. Coughing is necessary to clear mucus and debris bacteria from the lungs, so check with your child’s health care provider before using cough-suppressing syrups. Guaifenesin, an expectorant, promotes the production of thin mucus that is more easily removed by coughing.

WARNINGS:

  • These are not recomended for children under the age of 6.

Decongestants can relieve stuffiness caused by allergies or colds by temporarily shrinking the membranes in the nose to make breathing easier. They should not be used for more than two to three consecutive days. Decongestants taken by mouth can have a number of side effects such as irritability, sleeplessness, dizziness. Examples of decongestants include phenylephrine (found in Neo-Synephrine nose drops and other medicines); and pseudoephedrine (Sudafed, PediaCare Infant Decongestant Drops and other medicines).

WARNINGS:

  • These are not recommended for children under the age of 6.

Medicines for diarrhea. These are usually not necessary. Instead, give your child plenty of fluids and let the disease run its course. Diarrhea, however, can be dangerous in newborns and infants. In small children, severe diarrhea lasting just a day or two can lead to dehydration. Because a child can die from dehydration within a few days, you should see a health care provider as soon as possible if an infant has diarrhea. Talk to your provider before giving these medicines to infants or children.

WARNINGS:

  • Diarrhea medicines containing bismuth subsalicylate (Pepto-Bismol, Kaopectate, and other medicines) should NOT be given to a child younger than 19, as these could trigger Reye’s Syndrome, a deadly disease in children.
  • Loperamide (Imodium and other medicines), should NOT be given to a child younger than 6.

Laxatives relieve constipation and work by several methods. Some add fiber or water to stool to make it more bulky and easier for intestines to eliminate it; some coat the surface of the stool to make it more slippery; some soften the stool so it passes more easily; and others cause the intestines to contract more forcefully. Examples of laxatives include glycerin suppositories; magnesium citrate; magnesium hydroxide (Milk of Magnesia and other medicines); mineral oil (Agoral, Kondremul and other medicines); psyllium (Metamucil, Fiberall and other medicines); senna (Senokot, Ex-Lax and other medicines); methylcellulose (Citrucel and others), castor oil, and sodium phosphate (Fleet and other medicines).

WARNINGS:

  • DO NOT give infants or children laxatives without talking to your child’s health care provider.

Summary:
Aside from drugs for fever or pain, most over-the-counter products haven’t actually been studied in children for effectiveness, safety, or dosing.

  • When you give medicine to your child, be sure you’re giving the right medicine and the right amount.
  • Read and follow the label directions.
  • Use the correct dosing device. If the label says two teaspoons and you’re using a dosing cup with ounces only, don’t guess. Get the proper measuring device. Don’t substitute another item, such as a kitchen spoon.
  • Talk to your doctor, pharmacist, or other health care provider before giving two medicines at the same time. That way, you can avoid a possible overdose or an unwanted interaction.
  • Follow age and weight limit recommendations. If the label says don’t give to children under a certain age or weight, don’t do it.

Resources:
National Reye’s Syndrome Foundation, Food and Drug Administration, CDC, National Institutes of Health

Related Information:
What Is Reye’s Syndrome
Aspirin and Reye’s Syndrome
Other Names for Aspirin
Teens & Aspirin
Chicken Pox Parties
Herbal Remedies

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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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