FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr

EpiPen

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 customer.service@mylan.com 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.

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

 

The FDA asks health care professionals and consumers to report any adverse reactions or device malfunctions to the FDA’s MedWatch program, by:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm550170.htm

FDA approves dupilumab for moderate to severe eczema

eczema

“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.

 

Anatomy of a Electric Skateboard

Upon a first or quick glance, a skateboard looks pretty simple and innocuous. In layman’s terms, a skateboard deck is just a piece of wood with some wheels attached to its bottom. However, as with just about anything in life, upon closer inspection, you’ll quickly discover that there’s much more to a skateboard than meets the eye. Skateboards are, in fact, at the same time, complicated and delicate – which allows skateboarders the freedom to move about in any environment with precision, speed, toughness, and, when required, the ability to defy gravity and grind down rails. At the same time, expert riders and enthusiasts are also capable of performing incredible leaps, jumps and other mind-boggling tricks.

That’s pretty impressive for something which, at its core, is just a piece of wood with wheels affixed to its underside. So, what makes a skateboard a electric skateboard? What goes into its construction and development which allows professional and high-level skateboarders the ability to propel, jump, turn, twist and do all those other super-cool things? And while a skateboard would be pretty much useless without someone activating and using it, the design of the actual deck, from its trucks to its grip tape and everything in between, also has something to do with it too.

With that being said, there are certain elements and aspects which are nothing but absolutely critical to a skateboard. Without these components, a skateboard would literally be – as has been mentioned previously – just a piece of wood with wheels stuck to it. However, certain modifications and additions transform that ordinary wheeled piece of wood into a rolling, flying, grinding machine that has caught on in popularity like wildfire. So, when trying to distinguish a world-class skateboard from a simple piece of wood with wheels, try to keep an eye out for some of these vital pieces:

Deck

This is the piece of wood that’s more than a piece of wood. Skateboard decks usually are rectangular or oval in shape, and feature raised back-ends (sometimes called kick tails) and sloped front ends. And while yes, sometimes skateboard decks are made of wood, they can also be made from other materials such as plastic, fiberglass and even kevlar.

Grip Tape

Applied to the top surface of the skateboard deck like a sticker, grip tape is what keeps a skateboarder’s feet from slipping and sliding all over the place while they’re using the board. Grip tape has a tough, grinding feel to it, much like sandpaper does. While commonly seen in black, grip tape does indeed come in many different colors and styles.

Trucks

Skateboard trucks are attached directly to the underside of the skateboard deck. Somewhat shaped like a capital letter T, the wheels of the skateboard are connected to either end of the truck. There are two trucks per skateboard, and each truck holds two wheels, thus giving the skateboard four wheels in total. When thinking of a skateboard truck, try to picture the axles of an automobile.

Wheels

Without wheels, it would be very tricky, and very well near impossible, to actually move about on your skateboard deck. While skateboard wheels are commonly made from polyurethane, the actual size and diameter of the wheels can vary as well. There is no standard guidelines as to how big skateboard wheels can be, however, wheel sizes does depend on how you intend on using your skateboard.

Wheel Bearings

Without wheel bearings, the wheels which are attached to the board wouldn’t turn much, if at all. Bearings for a electric skateboards usually are manufactured in the standard 608 bearing size and are usually made from steel. However, that being said, other compounds, like silicon nitrade, can also be found in skateboard wheel bearings.

Fish oil supplementation during pregnancy may lower asthma risk

fish oil

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.
  • Probiotics.
  • Avoiding pets OR adding more pets.

A study, started in 1990 and recently completed and accepted for publication, looked at fish oil supplementation in pregnancy*. Over 500 pregnant mothers were given supplements containing fish oil, olive oil or no oil. The hypothesis was that maternal supplementation with long chain n-3 polyunsaturated fatty acids (PUFAs) may have immunological effects on the developing fetus and decrease allergies and asthma. The children were evaluated when they reached 18 years of age.

RESULTS:

The probability of having had asthma medication prescribed was significantly reduced in the fish oil group compared to the olive oil group (HR=0.54, 95% CI: 0.32-0.90, p=0.02). The probability of having had allergic rhinitis medication prescribed was also reduced in the fish oil group compared to the olive oil group (HR=0.70, 95% CI: 0.47-1.05, p=0.09), but the difference was not statistically significant. Self-reported information collected at age 18-19 years supported these findings.

CONCLUSION:

Maternal supplementation with fish oil may have prophylactic potential for long-term prevention of offspring asthma.

REFERENCE:

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.

Hypoallergenic dog or marketing myth?

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 “hypoallergnic 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.

TITLE: Can f1 levels in hair and homes of different dog breeds: Lack of evidence to describe any dog breed as hypoallergenic. JACI 2012.

CONCLUSIONS: Allergen levels in hair and coat samples were higher in breeds considered hypoallergenic. Although there was a lot of variability between dogs of each breed. The amount of allergen in dust samples was similar for hypoallergenic and other breeds. Although certain dog breeds are described and marketed as being “hypoallergenic”, no evidence was found that these breeds are less allergenic.

TITLE: Dog allergen levels in homes with hypoallergenic compared with nonhypoallergenic dogs. American Journal of Rhinology & Allergy 2011.

CONCLUSIONS: Clinicians should advise patients that they cannot rely on breeds deemed to be “hypoallergnic” to in fact disperse less allergen in their environment.

——————————————————

The evidence is pretty clear, at this time there is no “hypoallergenic” dog breed. Some dogs may produce more allergen than other dogs. Some people may be more allergic to one dog than other dogs. There is no consistency for which breed is best. Here are some tips for patients with dog allergy. Unfortunately, they are based more on common sense then scientific evidence.

Here is some more practical, but no better proven advice, for patients with dog allergies :

  • 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.

 

Nonceliac Wheat Sensitivity is associated with Autoimmune Disease

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 Now Available

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.

Flonase will go Over the Counter (OTC)

Nasocort is now Over the Counter (OTC)

Rhinocort OTC is now available

Many insurance companies are not covering any prescription nasal steroid sprays because others are available over the counter as we mentioned earlier. Although some patients seem to respond better to one more than another. Recently newer types of nasal steroid sprays have come on the market, Qnasl and Zetonna. These are nasal aerosol sprays that are not in a liquid form, so patients do not get the post nasal drip symptoms.

Generic Nasonex likely won’t be as cost prohibitive as the branded version of Nasonex, making it more affordable for patients. Nasonex is the only nasal steroid spray that has an indication for nasal polyps.

Seasonal and perennial allergic rhinitis is a major problem in the United States. Many allergy sufferers are allergic to allergens such as tree pollen, grass pollen, weed pollen, dust mites, cat dander, dog dander and molds. First line treatment for nasal congestion symptoms are nasal steroid sprays such as Nasonex. Generic Nasonex will be very helpful to many patients who did not insurance coverage for the branded version Nasonex, although it remains to be seen if insurance carriers will cover generic Nasonex or they still may say the patient will have to try over the counter versions of nasal steroid sprays such as Flonase, Nasocort or Rhinocort.

Sanofi US Issues Voluntary Nationwide Recall of ALL Auvi‑Q® Due to Potential Inaccurate Dosage Delivery

Sanofi US Issues Voluntary Nationwide Recall of ALL Auvi‑Q®
Due to Potential Inaccurate Dosage Delivery

More questions?
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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.