The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty. While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated. Consumers should keep and use their current EpiPens if needed until they get a replacement. Consumers should contact Mylan at 800-796-9526 or firstname.lastname@example.org with any questions. As stated on the product label, consumers should always seek emergency medical help right away after using their EpiPens, particularly if the device did not activate. At this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall. Consumers who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date.
The FDA asks health care professionals and consumers to report any adverse reactions or device malfunctions to the FDA’s MedWatch program, by:
|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||April 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|
- Completing and submitting the report online at www.fda.gov/medwatch/report.htm, or
- Downloading and completing the form, then submitting it via fax at 800-FDA-0178.
“Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Dupixent® (dupilumab) Injection, the first and only biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.” After much anticipation, dupilumab becomes the first biologic approved for the treatment of atopic dermatitis (a form of eczema). Dupilumab is indicated for adults with moderate to severe eczema that are not well controlled with steroid creams or ointments. The current options for these patients are limited. Most often oral immunosuppressants, like prednisone or cyclosporine, are used. These medications may have several adverse effects. Dupilumab is a biologic that aims to more specifically target the underlying factors driving allergic inflammation. In this case it blocks the signals of two molecules, Il-4 and IL-13. Approval was based on three studies. The results of these studies showed the medication to be effective for the majority of patients. Additionally, 36-38% of patients achieved clear to almost clear skin. Dupilumab will come in a pre-filled syringe for self-administration, to be given by subcutaneous injection every other week. A loading dose in your physician’s office may be required. The wholesale cost was reported $37,000 per year. However, the actual cost to patients is still unknown. Future directions. Two studies are currently testing safety and effectiveness in children, 6 months to 11 years and 12 to 17 years of age. Other uses under investigation include asthma, nasal polyps and eosinophilic esophagitis. If you do have atopic dermatitis that is not well controlled, speak to your allergy doctor to see if dupilumab is right for you. To read more about dupilumab, click here. Also, to read about nemolizumab, a new and similar treatment option, click here.
Preventing allergy is a priority for both physicians and parents. There have been many studies attempting to lessen the risk of both food and environmental allergies. Here are a few examples of possible interventions to decrease the risk of allergy;
- Frequent application of emollients (moisturizers) from birth.
- Breast feeding, hypoallergenic formulas, early introduction of foods.
- Avoiding pets OR adding more pets.
Hansen S, Strøm M, Maslova E, Dahl R, Hoffmann HJ, Rytter D, Bech BH, Henriksen TB, Granström C, Halldorsson TI, Chavarro JE, Linneberg A, Olsen SF, Fish oil supplementation during pregnancy and allergic respiratory disease in the adult offspring, Journal of Allergy and Clinical Immunology (2016), doi: 10.1016/j.jaci.2016.02.042.
Spring pollen season has arrived! Check back here (or twitter.com/allergyct) for Fairfield County’s only local counts.
Dog allergies are very common, up to 20% of the population are affected. This has not limited the popularity and enjoyment of having a dog at home. The ASPCA estimates that 37-47% of all households in the United States have a dog. Patients with dog allergies may have upper respiratory symptoms (sneezing, runny nose, itchy eyes), lower respiratory symptoms (cough, wheezing) or even skin symptoms (itching, rash). An allergist can confirm dog allergy as the cause of these symptoms. What’s next? What are the options? Removing the dog from the home is an option, but not very pleasing for the owners or their dogs. There are medications that can lessen symptoms. However, patients are looking for other ideas. Suggestions have included, frequent washing, frequent vacuuming, putting air filters in the house and buying a “hypoallergenic dog.” What is a “hypoallergenic dog?” The substance produced by a dog, causing an allergy is an allergen. The word hypoallergenic means less likely to cause allergy. This implies that the dog would produce less allergen. As of today, there have been six identified dog allergens, named Can f 1, 2, 3, 4, 5 and 6. These proteins are found in hair, skin, dander (skin flakes), saliva and urine. Each allergen can be found in each type, or breed of dog. Can f 1 and 5 are considered major allergens, causing allergy in a large percentage of patients. However, patients can be allergic to any single allergen or any combination as well. Interestingly, Can f 5 is found only in male dog urine, suggesting that some patients may be allergic to male dogs only. These proteins come off the dog and are found throughout the home. For example in carpets, couches and pillows. They can also be found in places without a dog. For example, in a classroom or on an airplane. A Google search will recommend, if you have allergies buy a hypoallergenic dog. Dogs that do not shed or with wiry hair. So is there such thing as a hypoallergenic dog? A dog breed that produces less allergen than other breeds? Is there anyone certifying or testing breeds to show that there are real benefits? Here are a few studies that may answer these questions: TITLE: Dog factor differences in Can f 1 allergen production. Allergy 2005. CONCLUSIONS:
- Allergen levels (Can f 1) were highest for Poodles (17) and Yorkshire Terriers (16) and lowest for the Labrador retriever (2).
- Males produced less allergen than females.
- There was no difference according to hair length or hormonal status.
- Skin seborrhea caused higher allergen levels.
- Choose a small dog. They will shed less dander.
- Keep the dog out of the bedroom and other rooms in which you spend a lot of time.
- Keep the dog out of the house. Remember, dogs may bring pollen or other allergens inside with them.
- Bathe your dog weekly.
- Remove carpet or other places dog dander may reside.
- Get a cat.
- MOST IMPORTANTLY: see an Allergist.
There is much interest in wheat sensitivity in people without celiac disease, many of these patients have been labeled with nonceliac wheat sensitivity. Little is known about any risks associated with nonceliac wheat sensitivity. A recent study published in the journal of Gastroenterology evaluated autoimmune diseases in patients with nonceliac wheat sensitivity and investigated whether they carry the autoimmune antibody (ANA). The study looked at patients who were given the diagnosis of nonceliac wheat sensitivity, celiac disease and control subjects. The ANA (autoimmune antibody) was measured in 3 groups. The authors concluded from the study that significantly higher proportions of patients with nonceliac wheat sensitivity or celiac disease have autoimmune disorders with positive ANA’s. This data provides physicians with an awareness that patients with nonceliac wheat sensitivity might have an increased risk of autoimmune diseases. Nonceliac wheat sensitivity remains a not well defined clinical condition. In fact there are some doubts about whether it is a real diagnosis. This study showed a higher frequency of autoimmune diseases, in particular thyroiditis, psoriasis and type 1 diabetes mellitus were reported. Allergists see many patients who are concerned regarding gluten allergy, many patients may in fact have nonceliac wheat sensitivity. This is relatively new diagnosis that there is not much information about. These are patients who do not have celiac disease or wheat allergy, but do have problems with eating gluten and/or wheat. Although allergy testing may be negative for these patients, this study shows that patients with nonceliac wheat sensitivity may have some autoimmune issues. There is still a lot to learn about nonceliac wheat sensitivity and as more studies come out we will learn more about it. Celiac disease has been in the news a lot recently http://allergylosangeles.com/allergy-blog/gluten-free-in-the-news/ As always speak to your doctor about any concerns that you have regarding gluten or wheat.
Generic Nasonex will soon be available for allergy sufferers. Apotex, is a generic pharmaceutical company, based in Florida, has successfully gotten FDA approval of the generic Nasonex (mometasone furoate). Generic Nasonex will still need a prescription. This is different than over the counter nasal steroid sprays that are available without a prescription from your doctor. There are currently 3 over the counter nasal steroid sprays available. Flonase, Nasocort and Rhinocort.
Sanofi US Issues Voluntary Nationwide Recall of ALL Auvi‑Q® Due to Potential Inaccurate Dosage Delivery More questions? Click here for additional information. > Due to high volume of calls being received on the Auvi‑Q customer service phone line, callers may periodically receive a message that the line is down. We appreciate your patience and please call back. Sanofi US is voluntarily recalling ALL Auvi‑Q® (epinephrine injection, USP). The recall involves ALL Auvi‑Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths. The Lot numbers include every consecutive lot number beginning with 2081278 through 3037230. The products have been found to potentially have inaccurate dosage delivery. If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life‑threatening condition. As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the US and Canada. None of these device malfunction reports have been confirmed. In these reports, patients have described symptoms of the underlying hypersensitivity reaction. No fatal outcomes have been reported among these cases. Auvi‑Q (epinephrine injection, USP) is used to treat life‑threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions. Auvi‑Q is packaged with two active devices and one trainer device in a corrugate box. Auvi‑Q was distributed throughout the United States via wholesalers, pharmacies and hospitals. All Auvi‑Q is being recalled. Sanofi US is notifying its distributors and customers who include doctors, pharmacies, wholesalers and other customers in the supply chain by letter, fax, email and phone calls and is arranging for return and reimbursement of all recalled products. Customers with questions regarding this recall can go to www.Auvi‑Q.com and call 1‑877‑319‑8963 or 1‑866‑726‑6340 Monday through Friday 8 a.m. to 8 p.m. ET for information about how to return their Auvi‑Q devices. Sanofi US will provide reimbursement for out of pocket costs incurred for the purchase of new epinephrine auto‑injectors with proof of purchase. Customers should immediately contact their healthcare provider (HCP) for a prescription for an alternate epinephrine auto‑injector. In the event of a life‑threatening allergic reaction (anaphylaxis), patients should only use their Auvi‑Q device if another epinephrine auto‑injector is not available, and then call 911 or local medical emergency services. Customers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product. Any adverse events or quality problems experienced with the use of this product should be reported either to Sanofi or to the FDA’s MedWatch Program. To report an adverse event to Sanofi US: call 1‑800‑666‑1630, Option 2. To report an adverse event to the FDA Med Watch Program: by fax 1‑800‑FDA‑0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852‑9787 or on the MedWatch website at www.fda.gov/medwatch/report.htm This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Sanofi US is committed to patient safety and the quality of Auvi‑Q, and will continue to work closely with customers and regulatory authorities to resolve this issue in a timely manner.