Allergies

Allergy Relief for Your Child

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Highlights

• Immune System Reaction
• Avoiding the Culprit
• Allergy Medicines
• More Child-Friendly Medicines
• Allergy Shots
• Transformation in Treatment
• FDA-Approved Options for Treatment of Allergic Rhinitis (Hay Fever) in Children

Children are magnets for colds. But when the sniffles and sneezing won’t go away for weeks, the culprit may be something else: allergies.

Long-lasting sneezing, with a stuffy or runny nose, may signal the presence of allergic rhinitis—the collection of symptoms that affect the nose when you have an allergic reaction to something you breathe in and that lands on the lining inside the nose.

Allergies may be seasonal or they can strike year-round (perennial). In most parts of the United States, plant pollens are often the cause of seasonal allergic rhinitis—more commonly called hay fever. Indoor substances, such as mold, dust mites, and pet dander, may cause the perennial kind.

Up to 40 percent of children suffer from allergic rhinitis, according to the National Institute of Allergy and Infectious Diseases (NIAID). And children are more likely to develop allergies if one or both parents have allergies.
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The U.S. Food and Drug Administration (FDA) regulates both over-the-counter (OTC) and prescription medicines that offer allergy relief as well as allergen extracts used to diagnose and treat allergies. And parents should take particular care when giving these products to children.

​Immune System Reaction

An allergy is the body’s reaction to a specific substance, or allergen. Our immune system responds to the invading allergen by releasing histamine and other chemicals that typically trigger symptoms in the nose, lungs, throat, sinuses, ears, eyes, skin, or stomach lining.

In some children, allergies can also trigger symptoms of asthma—a disease that causes wheezing or difficulty breathing.
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If a child has allergies and asthma, “not controlling the allergies can make asthma worse,” says Anthony Durmowicz, M.D., a pediatric pulmonary doctor in FDA’s Division of Pulmonary, Allergy, and Rheumatology Products.

Avoiding the Culprit

​If your child has seasonal allergies, you may want to pay attention to pollen counts and try to keep your child inside when the levels are high.

• In the late summer and early fall, during ragweed pollen season, pollen levels are highest in the morning.
• In the spring and summer, during the grass pollen season, pollen levels are highest in the evening.
• Some molds, another allergy trigger, may also be seasonal. For example, leaf mold is more common in the fall.
• Sunny, windy days can be especially troublesome for pollen allergy sufferers.

It may also help to keep windows closed in your house and car and run the air conditioner.

Allergy Medicines

For most children, symptoms may be controlled by avoiding the allergen, if known, and using OTC medicines. But if a child’s symptoms are persistent and not relieved by OTC medicines, it is wise to see a health care professional to assess your child’s symptoms and see if other treatments, including prescription medicines, may be appropriate. There are seven options available (see table below) to help bring your child relief. Although some allergy medicines are approved for use in children as young as 6 months, Dianne Murphy, M.D., director of FDA’s Office of Pediatric Therapeutics, has some cautions. “Always read the label to make sure the product is appropriate for your child’s age,” Murphy says. “Just because a product’s box says that it is intended for children does not mean it is intended for children of all ages.”

Another reason to carefully read the label is that even though the big print may say the product is for a certain symptom (sneezing, allergy, cough, etc.), different products may have the same medicine (active ingredient). So it might seem that you are buying different products to treat different symptoms, but in fact the same medicine could be in all the products. The result: You might accidently be giving too much of one type of medicine to your child.
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“Children are more sensitive than adults to many drugs,” adds Murphy. “For example, some antihistamines can have adverse effects at lower doses on young patients, causing excitability or excessive drowsiness.”

More Child-Friendly Medicines

Recent pediatric legislation, including a combination of incentives and requirements for drug companies, has significantly increased research and development of drugs for children and has led to more products with new pediatric information in their labeling. Since 1997, a combination of legislative activities has helped generate studies in children for 600 products.

Many of the older drugs were only tested in adults, says Durmowicz. “But we now have more information available for the newer allergy medications,” he adds. “With the passing of this legislation, there should be more confidence in pediatric dosing and safety with the newer drugs.”

The legislation also requires drugs for children to be in a child-friendly formulation, adds Durmowicz. So if the drug was initially developed as a capsule, it has to also be made in a form that a child can take, such as a liquid with cherry flavoring, rapidly dissolving tablets, or strips for placing under the tongue.
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In February 2016, FDA approved a generic version of Flonase Allergy Relief, an over-the-counter-allergy symptom reliever nasal spray for the temporary relief of the symptoms of hay fever or other upper respiratory allergies. In March 2016, FDA approved the first generic version of Nasonex spray for the treatment of nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 and older.

Allergy Shots

Jay E. Slater, M.D., director of FDA’s Division of Bacterial, Parasitic and Allergenic Products, who is also a pediatric allergist says that children who don’t respond to either OTC or prescription medications, or who suffer from frequent complications of allergic rhinitis, may be candidates for allergen immunotherapy—commonly known as allergy shots. According to NIAID, about 80 percent of people with allergic rhinitis will see their symptoms and need for medicine drop significantly within a year of starting allergy shots.

After allergy testing, typically by skin testing to detect what allergens your child may react to, a health care professional injects the child with “extracts”—small amounts of the allergens that trigger a reaction. The doses are gradually increased so that the body builds up immunity to these allergens.

Allergen extracts are manufactured from natural substances, such as pollens, insect venoms, animal hair, and foods. More than 1,200 extracts are licensed by FDA.

In 2014, FDA approved three new immunotherapy products to be taken under the tongue for treatment of hay fever caused by certain pollens, two of them for use in children. All of them are intended for daily use, before and during the pollen season. They are not meant for immediate symptom relief. Although they are intended for at-home use, these are prescription medications, and first doses are to be taken in the presence of a health care provider. The products are Oralair, Grastek, and Ragwitek (which is approved for use in adults only).
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“Allergy shots are never appropriate for food allergies,” adds Slater, “but it’s common to use extracts to test for food allergies so the child can avoid those foods.”

Transformation in Treatment

“In the last 20 years, there has been a remarkable transformation in allergy treatments,” says Slater. “Kids used to be miserable for months out of the year, and drugs made them incredibly sleepy. But today’s products offer proven approaches for relief of seasonal allergy symptoms.”

Forgoing treatment can make for an irritable, sleepless, and unhappy child, adds Slater, recalling a mother saying after her child’s successful treatment, “I didn’t realize I had a nice kid!”
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Fighting Allergy Season with Medications

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Highlights:

• About Allergies
• Testing
• Medications to Treat Symptoms
• Medications that Help Desensitize

You’re sneezing, your eyes are itchy and you feel miserable. Seasonal allergies aren’t just a nuisance, they are real diseases that can interfere with work, school or recreation, and can range from mild to severe.
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May is National Asthma and Allergy Awareness Month, and many allergy treatment options are approved by the Food and Drug Administration (FDA). For the first time, these include three sublingual (under the tongue) prescription products to treat hay fever (also called “allergic rhinitis”)—with or without eye inflammation (called “conjunctivitis”)—caused by certain grass pollens and short ragweed pollen. The new products—Grastek, Oralair and Ragwitek—can be taken at home, but the first dose must be taken in a health care provider's office.

About Allergies

An allergy is a heightened immune system reaction to a substance that your body has identified as an invader. If you have allergies and encounter a trigger—called an “allergen”—your immune system fights it by making antibodies, which causes your body to release chemicals called histamines. Histamines are responsible for symptoms such as repetitive sneezing and itchy, watery eyes.

Allergic rhinitis affects more than 30 million children and adults in the United States and more than 500 million people worldwide. It may be seasonal or year-round.

The seasonal allergy, often called “hay fever,“ typically occurs in the spring, summer or fall. If you have this, you may suffer from repetitive sneezing, and stuffy or runny nose and itching in the nose, eyes or on the roof of the mouth. Eye inflammation can occur when your eyes react to allergens with symptoms of reddening, itching and swelling.

Plant pollens usually cause seasonal allergies. Pollen allergies are common, and allergy-causing pollen can come from trees, weeds and grasses, according to the National Institute of Allergy and Infectious Diseases. Trees and grasses are typical spring culprits in the United States, while ragweed and other weeds ramp up in late summer and early fall.
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Indoor substances, such as dust mites, often cause the year-round type of allergies. Molds can cause seasonal and year-round allergies.

Testing

If you suspect an allergy, see your health care provider, as conditions such as upper respiratory infections, sinus infections and eye infections can have similar symptoms.
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“The first step is to get appropriate testing to determine what you’re actually reacting to,” says Jay Slater, M.D., an allergist and director of FDA’s Division of Bacterial, Parasitic and Allergenic Products.
Your health care provider can test you using injectable allergen extracts. Allergen extracts are sterile liquids made from natural substances such as molds, pollens or animal hair. FDA has licensed these products. Tests include:

• a skin prick test, which involves placing the allergen extract on your skin and pricking so it goes under the skin’s surface. Your skin is studied for swelling or other signs of a reaction, which usually occurs in about 15 minutes.
• an injection of a small amount of an allergen, or
• a blood test, which can detect and measure antibodies to certain allergens.

Medications to Treat Symptoms

“After testing, you need to sort out results with your health care provider,” Slater says. “Take the results of the test and combine it with reflective thinking about when and where you’re experiencing symptoms. Then determine the best course of action.”

For instance, if you have a spring oak tree allergy you can try to avoid the allergen by limiting outdoor activities on high pollen-count days and keeping your windows closed. But airborne pollen can be hard to avoid, so your health care provider may also recommend prescription or over-the-counter medications to relieve symptoms.

Antihistamines reduce or block symptom-causing histamines and are available in many forms, including tablets and liquids.

“There are several different antihistamines. First-generation antihistamines include medications such as diphenhydramine, marketed under the brand name Benadryl. They have been available over the counter for a long time,” says Narayan Nair, M.D., a medical officer at FDA. “Newer second generation antihistamines have not been available over the counter as long. They include medications such as fexofenadine and loratadine, which are marketed under the brand names Allegra and Claritin, respectively.”

When choosing an over-the-counter antihistamine, patients should read the Drug Facts label closely and follow dosing instructions, Nair says. “Some antihistamines can cause drowsiness and interfere with the ability to drive or operate heavy machinery. The drowsiness can be made worse by taking sedatives or consuming alcohol,” he explains. “Also, patients with chronic conditions such as glaucoma, or an enlarged prostate should talk to their health care provider before taking certain antihistamines.”
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In addition to the antihistamines, nasal sprays and eye drops can help improve some allergic symptoms. “Nasal sprays can help relieve nasal symptoms but they should only be used for a limited time without talking to a health care provider. If some nasal sprays are used longer than intended they can make the congestion worse,” Nair notes.

Medications that Help Desensitize

If you don’t respond to medications to relieve symptoms, you may be a candidate for allergen immunotherapy, often given via “allergy shots” that have small amounts of the allergen. These shots can decrease sensitivity to inhaled allergens.

Patients can receive weekly injections from a health care provider for two to three months, during which time the dose increases, Slater says. After the maximum dose is reached, treatment can continue monthly for three to five years.

The prescription sublingual treatments approved in April—Grastek, Oralair, and Ragwitek—also are an immunotherapy option. “These medications have the potential for dialing down the immune response to allergens, doing more than just treating the symptoms of allergies,” says Slater. Sublingual therapy should start three to four months prior to allergy season so, depending on your geographic location, it may be something to explore in the next year.

Allergenic treatments can result in reactions such as swelling in the place where they are administered, or systemic reactions that can affect the airway. “For injection therapy, local side effects like itching and swelling can be annoying but not life-threatening,” Slater explains. But for the medications taken under the tongue, you must be especially careful to pay attention to side effects such as swelling.

Due to the potential for serious complications, you must take the first sublingual treatment under medical supervision. After that, you can take treatments daily at home, and your health care provider must prescribe an autoinjectable epinephrine device in case you need it for a severe reaction. You should read the medication guide that is distributed with Grastek, Oralair and Ragwitek each time you fill a prescription.

“For sublingual therapy, the fact that it’s not an injection will be an advantage to some individuals. And the fact that, aside from the first visit, it doesn’t require follow-up office visits will also be an advantage,” Slater says.
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“What’s limiting for sublingual therapy compared to injection therapy is the availability of products. Now, we have sublingual medications for treatment of allergic rhinitis with or without conjunctivitis caused by short ragweed and certain grass pollens, but plenty of other substances induce allergies and affect people, sometimes dramatically,” Slater continues. “With injection immunotherapy, health care providers have more flexibility in terms of treating patients who may have multiple allergies or allergies not covered by sublingual products.”

Allergy Meds Could Affect Your Driving

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Highlights:

• Precautions to Take
• Tips to Keep in Mind

​If you can literally write your name in pollen on the windshield of your car, you know it is allergy season again.

When your body comes into contact with whatever triggers your allergy—pollen, ragweed, pet dander, or dust mites, for example—it produces chemicals called histamines. Histamines cause the tissue in your nose to swell (making it feel stuffy), your nose and eyes to run, and your eyes to itch. Some people develop itchy skin rashes known as hives.

Medications containing antihistamines, drugs which counteract the effect of histamines, can help relieve many different types of allergies, including hay fever and food allergies.

But some antihistamines can make you feel drowsy, unfocused and slow to react.  If not taken responsibly and according to directions, they can pose a danger to your health and safety. Information about whether an antihistamine medication can make you drowsy can be found in the product’s label.  Consumers should read the Drug Facts label of the medication and understand the warnings before they use it.
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“Any of these reactions can negatively interfere with driving or operating heavy machinery,” says Jane Filie, M.D., a medical officer at the Food and Drug Administration’s (FDA) Division of Nonprescription Regulation Development. Filie says you may experience slower reaction time, haziness, or mild confusion even if you don’t feel drowsy after taking a medication containing antihistamines.

Precautions to Take

FDA wants to promote awareness of the potential health risks and the precautions that you should take when using antihistamines.

Different antihistamines may be dosed differently, says FDA pharmacist Ayana Rowley, Pharm.D. “Don’t assume that when you run out of one antihistamine and happen to buy another, it’s the same dose,” she explains. If one specific antihistamine worked for you before, take note of the dosage and make sure you get the same medication the next time.

It’s also important to avoid taking alcohol, sedatives (sleep medications), or tranquilizers while taking some antihistamines.  This information can also be found in the Drug Facts label, Filie says. Alcohol and sedatives can seriously increase the sedative effects that already may occur when taking antihistamines.
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Rowley also cautions against self-medicating. “If the correct dosage isn’t providing you the relief you expect, don’t simply keep taking more and more of that product,” she says, “but instead, consult with your health care professional”.

Tips to Keep in Mind

• Always follow directions for use and read warnings on the packages of the drug products you purchase.
• Some antihistamines may cause drowsiness, and you need to exercise caution when driving a motor vehicle or operating machinery. Avoid using alcohol, sedatives, and tranquilizers while taking the product because they may increase drowsiness.
• Know that some antihistamines take longer to work than others. Recognize that you might feel the sedating effects of these medications for some time after you’ve taken them and possibly even the next day.

Source:  U.S. ​Food and Drug Administration (FDA)

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