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Month: June 2023

Epinephrine Nasal Spray

Allergic reactions can sometimes be life-threatening. Anaphylaxis is a severe allergic reaction that is characterized by a sudden onset of symptoms with rapid progression. The manifestations may include generalized itching (i.e., pruritus), hives (i.e., urticaria), swelling (i.e., angioedema) of soft body parts, rapid pulse rate, a precipitous drop in blood pressure, dizziness, nausea, vomiting, abdominal pain, wheezing, shortness of breath, and/or loss of consciousness. Anaphylactic reactions are usually triggered by allergies to foods (e.g., peanuts, tree nuts, fish, shellfish), insect venoms (e.g., bee, wasp, yellow jacket, hornet, fire ant), and/or medications.

Administration of epinephrine immediately after the onset of an anaphylactic reaction usually stops the reaction from progressing and can be lifesaving. Occasionally, more than one dose of epinephrine is needed to reverse the untoward effects of anaphylaxis. Until now, the only approved route of the administration of epinephrine into the body has been through an injection with a syringe and needle. Epinephrine auto-injector devices such as EpiPen, Auvi-Q, and Adrenaclick have been available for several years. These self-injectable epinephrine devices are easy to use and allows the patient to administer epinephrine as soon as early anaphylactic allergic symptoms develop.

On May 11, 2023, an expert panel of advisers recommended to the Food and Drug Administration’s (FDA) that they approve an epinephrine nasal spray product, clearing a key hurdle for what could soon be the first needle-free option for treating severe allergic reactions.

The device which is designed to deposit epinephrine into the nostril is called Neffy. The same device was previously approved to administer a medication called naloxone into the nose to reverse the effects of a narcotic overdose.

Neffy delivers 2 mg. of epinephrine which is suitable for patients weighing above 30 kilograms (66 lbs.). The FDA is likely to decide on the final approval process in the next few months. If approved, the device will be available for use before the end of the 2023 year.

During clinical trials, the epinephrine nasal spray administration was compared with the previously approved injectable epinephrine products (i.e., EpiPen, Auvi-Q, Adrenaclick) in more than 600 individuals. The nasal spray has demonstrated comparable efficacy and rapidity of action, in most cases within a minute of administration. The effects on blood pressure and pulse rate, which were surrogate markers for the reversal of reaction, were non-inferior to injectable epinephrine. When a second dose is needed, the nasal spray showed a slightly better response than with injections. The epinephrine concentrations in the bloodstream also did not differ substantially with either route of administration.

Neffy’s safety profile was comparable with an injection of epinephrine with mild reactions that did not include any meaningful nasal irritation or pain. Intranasal delivery and pharmaco-dynamic response also were effective even with nasal congestion or a runny nose, such as when patients are experiencing allergic rhinitis (i.e. hay fever) or an upper respiratory tract infection (URI).

During clinical studies, the researchers also found that patients are more likely to use the nasal spray much earlier than the injection, which is advantageous in reversing the anaphylactic reaction. The other benefits of the nasal spray are that the nasal spray is more convenient to carry and there obviously was no needle- related injuries since no needle is needed.

If approved by FDA, the intranasal epinephrine could offer a preferred alternative to injectable epinephrine devices and meet an unmet need. Many individuals fail to use self-injectable epinephrine devices when anaphylaxis arises. Some find the pen-style devices inconvenient to carry. Some are reluctant to use them because they are fearful of needles, while others panic when an anaphylactic reaction occurs. Having an epinephrine nasal spray available is a welcome addition to the arsenal of medications used to combat and treat severe allergic reactions.

The board certified allergy specialists at Black & Kletz Allergy has 3 locations in the Washington, Northern Virginia, and Maryland metropolitan area. We have offices in Washington, DC, McLean, VA (Tysons Corner, VA), and Manassas, VA. All 3 of our offices have on-site parking and the Washington, DC and McLean, VA offices are Metro accessible. The McLean office has a complementary shuttle that runs between our office and the Spring Hill metro station on the silver line. The allergists of Black & Kletz Allergy diagnose and treat both adult and pediatric patients. For an appointment, please call our office or alternatively, you can click Request an Appointment and we will respond within 24 hours by the next business day. The allergy doctors at Black & Kletz Allergy have been helping patients with anaphylaxis, hives, insect sting allergies, food allergies, medication allergies, hay fever, asthma, sinus disease, eczema, and immunological disorders for more than 5 decades. If you suffer from allergies, it is our mission to improve your quality of life by reducing or preventing your undesirable and irritating allergy symptoms.

Mold Allergy Update

Mold allergies are very common, particularly in the Washington, DC, Northern Virginia, and Maryland metropolitan area. The reason why there appears to be a high prevalence of mold-allergic individuals in the Washington, DC metro area may be tied to the fact that Washington, DC was built on a swamp. The climate in this mid-Atlantic region is conducive to mold growth due to its relative humidity. In the Spring there is a lot of rain. The Summers are very humid. In the Fall, the leaves from trees fall to the ground and subsequently develop “leaf mold” on the leaves due to the decomposition of the leaves by molds. Although decomposition of leaves is an important step in the mineralization of organic nutrients and the recycling of nutrients to plants, it is often met with dismay to allergy sufferers who are allergic to molds.

Molds are fungi that grow in the form of multicellular strands called hyphae. Fungi that circulate in a single celled environment are called yeasts. Molds are a common cause of hay fever (allergic rhinitis) and/or eye allergies (allergic conjunctivitis). Individuals that are allergic to molds may experience sneezing, nasal congestion, runny nose, post-nasal drip, itchy nose, sinus headaches, itchy eyes, watery eyes, and/or redness of the eyes. In some people, molds may cause asthma-like symptoms which may include wheezing, chest tightness, coughing, and/or shortness of breath. In asthmatics, molds may be a triggering factor which can cause a worsening of their asthma symptoms. The treatment of allergic rhinitis, allergic conjunctivitis, or asthma due to mold allergies usually involves reducing the exposure to molds, if possible. Common medications that are used may include antihistamines, decongestants, mast cell stabilizers, topical corticosteroids, anticholinergics, inhaled beta-agonists, leukotriene antagonists, and occasionally biological medications. Allergy immunotherapy (i.e., allergy shots, allergy injections, allergy desensitization) is very effective in the treatment of mold allergies as it helps in 80-85% of patients on the injections. The average length of time on allergy immunotherapy is typically 3-5 years.

Not only can molds not cause allergy symptoms, but molds can in fact affect individuals in 3 other major ways: 1. Act as an irritant; 2. Cause infection; or 3. Act as a toxin.

Molds can cause an irritant reaction which is similar to an allergic reaction but this type of reaction is not technically allergic since there is not an immune reaction to the molds. Irritant reactions are also called nonallergic rhinitis. Individuals that have an irritant response to molds typically experience symptoms such as irritated eyes, nose, throats and/or lungs. Examples of irritant reactions include a runny nose after eating horseradish or burning and watery eyes from freshly cut onions. The best treatment of irritant reactions to molds is to avoid exposure to molds. If one cannot avoid exposure, medications may be used to help minimize the symptoms of the irritant reaction. Such medications may include oral antihistamines, oral decongestants, nasal antihistamines, nasal decongestants, nasal corticosteroids, nasal anticholinergics, and/or ocular medications.

Fungi and molds can cause infections in certain individuals, particularly those who are immunocompromised or have a “low” immunity. Individuals can be immunocompromised for a variety of reasons which may include medications (e.g., corticosteroids, tacrolimus, cyclosporine, biological monoclonal antibodies, azathioprine), immunodeficiencies (e.g., hypogammaglobulinemia, Bruton’s agammaglobulinemia, IgG subclass deficiency, common variable immunodeficiency), HIV/AIDS, elderly individuals, radiation, cancer, malnutrition, and stress after surgery, to name a few. Fungi tend to infect the sinuses, brain, eyes, lungs, nails, esophagus, tongue, and/or bloodstream. The fungal infection can be either systemic or superficial. Systemic fungal infections tend to occur more in immunosuppressed individuals and may be life-threatening. It is important to note that superficial fungal infections of the nails, tongue, and skin are common in normal individuals without compromised immune systems. Fungal infections of the lungs, brain, bloodstream, esophagus, sinuses, and eyes that are more problematic and tend to occur more often in patients with compromised immune systems. The treatment of fungal infections varies depending on the severity and location of the fungus. It should be noted that antifungal medications are used to treat fungal infections and may be given orally, topically or intravenously.

Molds may also act as a toxin in a condition called toxic mold syndrome. This syndrome is caused by mycotoxins (i.e., toxins produced by molds) and is sometimes referred to as sick building syndrome. Individuals with this disorder generally complain of a variety of non-specific symptoms as the symptoms may vary greatly from one individual to another. The symptoms may include watery eyes, itchy eyes, red eyes, runny nose, sore throat, rashes, headaches, nosebleeds, nausea, vomiting, dizziness, anxiety, fatigue, lack of concentration, mood swings, poor appetite, insomnia, weight loss, memory loss, hair loss, rashes, chest tightness, coughing, wheezing, and/or shortness of breath. Toxic molds grow most commonly on damp walls and ceilings. Toxic molds tend to manifest as black, brown, or green patches along with an associated musty odor.

The board certified allergists at Black & Kletz Allergy have expertise in diagnosing and treating mold allergies, as well as all types of other allergic conditions and asthma. We are board certified to treat both pediatric and adult patients and have been doing so in the Washington, DC, Northern Virginia, and Maryland metropolitan area for more than 50 years. Black & Kletz Allergy has offices in Washington, DC, McLean, VA (Tysons Corner, VA), and Manassas, VA. All 3 of our offices have on-site parking. For further convenience, our Washington, DC and McLean, VA offices are Metro accessible. Our McLean office location offers a complementary shuttle that runs between our office and the Spring Hill metro station on the silver line. For an appointment, please call our office or alternatively, you can click Request an Appointment and we will respond within 24 hours by the next business day. If you suffer from mold allergies, we are here to help alleviate or hopefully end these undesirable symptoms so that you can enjoy a better quality of life. Black & Kletz Allergy is devoted to providing the highest quality allergy care in a caring, relaxed, and professional environment.