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FDA Approves New Epinephrine Prefilled Syringe

The US Food and Drug Administration (FDA) has approved an epinephrine prefilled syringe (Symjepi, Adamis Pharmaceuticals) for the emergency treatment of allergic reactions (type I), including anaphylaxis, the company has announced.

“Symjepi provides two single dose syringes of epinephrine (adrenaline), which is considered the drug of choice for immediate administration in acute anaphylactic reactions to insect stings or bites, allergic reaction to foods (such as nuts), drugs and other allergens, as well as idiopathic or exercise-induced anaphylaxis,” the company said in a news release.

Each Symjepi prefilled syringe contains 0.3 mg epinephrine.

“With an anticipated lower cost, small size and user-friendly design, we believe Symjepi could be an attractive option for a significant portion of both the retail (patient) and non-retail (professional) sectors of the epinephrine market,” Dennis Carlo, president and CEO of Adamis, said in the release.

“We are currently in the process of exploring all of our commercialization options and in discussions with potential partners in order to facilitate broad patient access to this new epinephrine treatment option and to maximize the value of our important asset. In the interim, we expect to build inventory levels in preparation for an anticipated launch in the second half of this year,” he added.

The company said it is also preparing to submit a second new drug application to the FDA for a junior version of Symjepi.

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Body weight and Asthma

When you are overweight or obese, most excess weight is usually in the central area of the body, or the midsection. This can reduce your lung volume, making you not able to breathe as well.

Also, the foods you put in your body are an important factor. With obesity, there’s often a pro-inflammatory diet that includes sugary, starchy foods. This can cause your body to release inflammatory hormones, such as leptin, that increase inflammation in the lungs and can lead to asthma symptoms.

Diseases that often occur with obesity, such as gastroesophageal reflux disease (GERD), diabetes and hypertension, have also been found to worsen asthma. So losing weight can also help you reduce the risk of developing these conditions.

Losing 10 pounds can make a huge difference in a person’s asthma symptoms. And as an added benefit, weight loss allows patients to be better able to exercise – obviously the less weight you have, the easier it is to move around. Regular exercise has been shown to improve not only asthma symptoms but also asthma outcomes.

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Asthma and Obstructive Sleep Apnea

A recent study demonstrates that asthmatic patients with obstructive sleep apnea (OSA) have a greater decline in lung function (FEV1) over time than those without OSA. The natural history of FEV1 decline in asthmatic patients has been reported to be about 40 ml/year, twice the normal age-related decline. Factors associated with the decline in pulmonary function are age, sex, smoking, acute exacerbations, and obesity.

This is also the first study reporting more exacerbations in asthmatic patients with OSA than in patients without OSA. CPAP treatment, however,  can reduce exacerbations in asthmatic patients with OSA. Such exacerbations are also associated with the decline in pulmonary function among asthmatic patients with OSA.

Finally, CPAP treatment was found to alleviate the accelerated decline in FEV1 in asthmatic patients with severe OSA.

 

 

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Do You Really Have Asthma?

 

Shortness of breath. Wheezing. Coughing. Chest tightness. If you had asthma, you’d know it, right? It turns out that it’s not always that simple, and even your doctor can get it wrong. When Canadian researchers studied more than 700 people who had been diagnosed with asthma in the past five years, they determined that one-third of them didn’t have asthma after all. Their study, published in JAMA, suggests that you might very well be treating a condition you don’t even have—while simultaneously neglecting your real issue.

How could this happen? Lead study author Shawn Aaron, MD, a senior scientist at the Ottawa Hospital Research Institute, suspects that doctors are often relying on symptoms to make a diagnosis, but “asthma” symptoms can overlap with those caused by other health problems. He says that physicians ought to be conducting an objective spirometry test, but some are skipping this step.

The test is simple—you blow into a tube, and the doctor measures how quickly you blow the air out—but only half of the patients in Aaron’s study were given one. “We think that doctors are taking shortcuts,” he says. “Although we can’t say exactly how many were misdiagnosed initially verses how many went into remission, we think a sizable proportion were misdiagnosed from the beginning.”

If you’ve been told you have asthma but haven’t had a spirometry test, see an asthma/immunology specialist to get tested now. “You wouldn’t let a physician give you insulin to treat diabetes without testing your blood sugar,” says Aaron. “Patients are accepting inhalers for asthma all the time without getting appropriate testing to confirm.”

 

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Epi-pen Recall

The United States has joined the list of countries covered by a voluntary recall of EpiPen auto-injectors for anaphylactic shock on account of a defective part that may result in the device failing to inject a potentially life-saving dose of epinephrine, the US Food and Drug Administration (FDA) announced today.

Mylan, the company that markets the device, announced earlier this month that it was recalling one lot of roughly 80,000 EpiPens in Australia, Europe, Japan, and New Zealand. It reported two instances of the device failing to deliver its dose. The patients in question, however, were treated successfully with backup, functioning EpiPens.

Pressing the EpiPen into a person’s thigh — the prescribed area for administration — causes a needle to penetrate skin and inject epinephrine into muscle. The defective part may require a person to use increased force to activate the needle, or it may prevent the EpiPen from working at all, according to Mylan.

The company announced today that it was expanding the recall not only to the United States, but also other markets in North America and South America.

In the United States, the recall applies to 13 lots of both EpiPen and EpiPen Jr. auto-injectors distributed between December 17, 2015, and July 1, 2016. Patients can receive another EpiPen or an authorized generic version at their pharmacy, Mylan said. In the meantime, they should continue to carry and use their current EpiPen until they acquire a replacement.

Product/Dosage

NDC Number

Lot Number

Expiration Date

EpiPen Jr Auto-Injector, 0.15 mg

49502-501-02

5GN767

April 2017

EpiPen Jr Auto-Injector, 0.15 mg

49502-501-02

5GN773

April 2017

EpiPen Auto-Injector, 0.3 mg

49502-500-02

5GM631

April 2017

EpiPen Auto-Injector, 0.3 mg

49502-500-02

5GM640

May 2017

EpiPen Jr Auto-Injector, 0.15 mg

49502-501-02

6GN215

September 2017

EpiPen Auto-Injector, 0.3 mg

49502-500-02

6GM082

September 2017

EpiPen Auto-Injector, 0.3 mg

49502-500-02

6GM072

September 2017

EpiPen Auto-Injector, 0.3 mg

49502-500-02

6GM081

September 2017

EpiPen Auto-Injector, 0.3 mg

49502-500-02

6GM088

October 2017

EpiPen Auto-Injector, 0.3 mg

49502-500-02

6GM199

October 2017

EpiPen Auto-Injector, 0.3 mg

49502-500-02

6GM091

October 2017

EpiPen Auto-Injector, 0.3 mg

49502-500-02

6GM198

October 2017

EpiPen Auto-Injector, 0.3 mg

49502-500-02

6GM087

October 2017

 

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Allergy Shots Fast-Track Relief

Conventional allergy immunotherapy requires a considerable time commitment since an allergy shot is given once or twice a week for about five months. The amount of allergen is gradually increased until a maintenance dose is reached, so there is no longer a reaction to the allergen. Research presented by allergist Richard Weber, MD, ACAAI vice president, shows allergists who use accelerated schedules known as cluster and rush immunotherapy find patients experience benefits faster and reach their maintenance dose sooner.

You shouldn t have to put your life on hold to treat your allergies, said Dr. Weber. Accelerated schedules offer patients more flexibility, faster results and a treatment plan they are more likely to follow because it reflects their needs and busy lifestyle.

Rush immunotherapy typically involves a patient getting multiple injections two or three days in a row, but schedules may be varied either shorter or longer to suit circumstances.

Cluster immunotherapy aims to help patients reach a point where they no longer react to the allergen in a few weeks by giving two to four injections 30 minutes apart for one day each week for three weeks.

Research shows accelerated schedules are safe and effective options, and they appeal to patients who do not want to commit to weekly allergy shots for five or six months, said Dr. Weber.

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Allergy Shots Cost Effective

Allergy shots, an age-old treatment for allergy sufferers, are getting a shot in the arm from new research. This proven therapy saves money, according to a recent study.

Allergy immunotherapy is the only treatment available that actually changes the immune system, making it possible to prevent the development of new allergies and asthma. According to research by Cheryl Hankin, PhD, BioMedEcon president and chief scientific officer, allergy immunotherapy also significantly reduces healthcare use and costs for prescription medications, outpatient visits, and inpatient stays.

Compared to children with allergies who did not receive allergy immunotherapy, children who received this treatment saved Florida Medicaid, on average, more than $1,000 within the first three months of treatment, and saved the state nearly $6,000 after 18 months. Results were even more compelling for adults. Average savings to Florida Medicaid were about $1,200 after three months of allergy immunotherapy, and exceeded $7,000 after 18 months.

Allergy immunotherapy is a well-established, safe and effective treatment.  Allergies and asthma are serious, high cost, debilitating, chronic illnesses. In light of the current U.S. healthcare crisis, these findings strongly suggest that it is in the best public health interest to promote increased access to allergy immunotherapy for patients who suffer from allergies.

 

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New drug approved for house dust mite allergy

The US Food and Drug Administration (FDA) has approved Odactra (Merck, Sharp & Dohme Corp), the first sublingual allergen extract for the treatment of house dust mite–induced allergic rhinitis, with or without conjunctivitis in adults aged 18 through 65 years.

“House dust mite allergic disease can negatively impact a person’s quality of life,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in an FDA news release. “The approval of Odactra provides patients an alternative treatment to allergy shots to help address their symptoms.”

Odactra reduces the occurrence and severity of nasal and eye allergy symptoms by desensitizing patients to house dust mite allergens. It is a tablet that is placed under the tongue, where it dissolves rapidly. Patients take Odactra once daily, year round.

Because it can cause life-threatening adverse reactions, the first dose is administered “under the supervision of a health care professional with experience in the diagnosis and treatment of allergic diseases,” the FDA explains in the news release. Patients must be observed for 30 minutes or longer for potential adverse reactions. If the patient tolerates the first dose well, they can continue taking it at home.

Patients may need to take Odactra daily for 8 to 14 weeks before they experience noticeable improvement in their symptoms.

The FDA’s decision follows consideration of data from clinical trials that involved about 2500 people in the United States, Canada, and Europe.

Patients who received Odactra reported a 16% to 18% reduction in their symptoms and the need for other symptom-relieving medications compared with patients who received a placebo.

The most frequently reported adverse events were nausea, itching in the ears and mouth, and swelling of the lips and tongue. The prescribing information includes a boxed warning that severe and sometimes life-threatening allergic reactions can occur. Clinicians should prescribe autoinjectable epinephrine to patients receiving Odactra, as with other FDA-approved sublingual allergen extracts. Odactra also comes with a medication guide to be given to the patient.

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Allergy to Marijuana

IgE-mediated Cannabis (C. sativa, marihuana) allergy seems to be on the rise. Both active and passive exposure to cannabis allergens may trigger a C. sativa sensitization and/or allergy. The clinical presentation of a C. sativa allergy varies from mild to life-threatening reactions and often seems to depend on the route of exposure. In addition, sensitization to cannabis allergens can result in various cross-allergies, mostly for plant foods. This clinical entity, designated as the ‘cannabis-fruit/vegetable syndrome’, might also imply cross-reactivity with tobacco, natural latex and plant-food-derived alcoholic beverages.

At present, diagnosis of cannabis-related allergies predominantly rests upon a thorough history completed with skin testing using native extracts from crushed buds and leaves. However, quantification of specific IgE antibodies and basophil activation tests can also be helpful to establish correct diagnosis. In the absence of a cure, treatment comprises absolute avoidance measures.

When cannabis is used for its psychoactive effects, drug (ab)users may become sensitized by inhalation of cannabis allergens through active smoking and/or vaporizing the drug. Cutaneous contact through handling of the drug is another possible route of sensitization.

C. sativa produces wind-borne pollen easily transported over long distances. However,  as only female (nonpollinating) plants are cultivated for illicit use, it is less likely for abusers of cannabis, who grow their own plants, to become sensitized to marihuana through pollen exposure.

The clinical presentation of an IgE-mediated cannabis allergy can vary considerably from mild to life-threatening reactions and seems to relate to the route of exposure. First, respiratory reactions like rhinitis, conjunctivitis, asthma and palpebral angioedema have been described. These reactions predominantly occur when cannabis is consumed by smoking or vaporizing.

Cross-reactivity between cannabis and plant-derived food has been described in multiple studies and was recently designated as the ‘cannabis-fruit/vegetable syndrome’. The foods most commonly implicated in this allergy syndrome are peach, apple, nuts, tomato and occasionally citrus fruit as orange and grapefruit.

It is important to note that the allergic reactions to these plant foods are often triggered or exacerbated by cofactors such as exercise or nonsteroidal anti-inflammatory drugs (NSAIDs) and are therefore variable which can make history taking more complex. Furthermore, these reactions are frequently more severe than the classic oral allergy syndrome (OAS) expected in food allergy related to sensitization to tree, grass or ragweed pollen.

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Allergy Shots during Pregnancy may Decrease Allergies in Children

Expecting mothers who suffer from allergies may want to consider another vaccination in addition to the flu shot and Tdap. A study  presented at the Annual Scientific Meeting of the American College of Allergy, Asthma and Immunology (ACAAI) found pregnant women who receive allergy shots, also known as immunotherapy, during pregnancy may decrease their baby’s chance of developing allergies.

“Our research found trends suggesting women receiving allergy shots either before or during pregnancy reduced their child’s chances of having asthma, food allergies, or eczema,” said allergist Jay Lieberman, MD, ACAAI member. “Prior studies have suggested that mothers can pass protective factors to their fetus that may decrease their child’s chance of developing allergic disease, and these protective factors are increased with allergy immunotherapy.”

While there is no cure for the more than 50 million Americans suffering from allergies, immunotherapy is known to modify and prevent disease progression.

According to ACAAI, allergies tend to run in families. If both parents have allergies, their children have a 75 percent chance of being allergic. If only one parent is allergic, or if a relative has allergies, the child has a 30 to 40 percent chance of having an allergy. If neither parent has allergy, the chance of a child developing an allergy is only 10 to15 percent.

“Allergy shots are not only effective but cost efficient,” said allergist Warner Carr, MD, chair of the ACAAI Immunotherapy and Diagnostics Committee. “Immunotherapy can result in health care savings of 33 to 41 percent.”

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