News Release Detail

October 23, 2009

For Parents of Kids with Food Allergies, the Scariest Thing at Halloween is the Trick-or-Treat Bag

BASKING RIDGE, N.J., Oct 23, 2009 /PRNewswire via COMTEX News Network/ -- The haunted happenings of Halloween are upon us and soon we'll be carving pumpkins, dressing in costumes and telling spooky stories. But if your child has a food allergy, what's at the bottom of his or her trick-or-treat bag may be more frightening than any ghost or goblin.

According to a new national survey of 678 moms of children with food allergies - whether to peanuts, tree nuts, milk or eggs, eight out of ten say Halloween causes a great deal of anxiety because they fear their little ones might eat candy containing peanuts or another allergen.(1) Their anxiety is heightened by the fact that food allergies can cause a potentially life-threatening severe allergic reaction called anaphylaxis. Anaphylaxis is caused when an allergic reaction becomes so severe that a person may stop breathing. Unfortunately, it is impossible to predict when a child with food allergies might experience an anaphylactic reaction.

According to the survey, 40 percent of moms said that this time of year makes their children feel alienated because the child can't fully engage or participate in Halloween activities.(1) The fear is so great that nearly half of these moms said they are thinking about having their child skip trick-or-treating altogether.

In spite of these concerns, less than half of moms surveyed are adequately prepared to handle a life-threatening allergic reaction - 43 percent of moms surveyed said they carry or have immediate access to an epinephrine auto-injector, such as EpiPen(R) (epinephrine) and EpiPen(R) Jr Auto-Injectors 0.3/0.15 mg.(1) EpiPen(R) Auto-Injector is a self-administered medicine that is used in the emergency treatment of a severe allergic reaction, including an anaphylactic reaction.

"The Halloween season can be an emotionally troubling time for children with food allergies because they are often faced with the temptation of delicious treats they can't eat and parties they can't fully enjoy. Halloween is also a frightening time for many parents who fear that their child might accidentally eat an allergen-containing piece of candy or treat while at school or out trick-or-treating," said Stacy DeBroff. "But there's no reason your son or daughter needs to miss out on all the fun this Halloween. With a good plan, they can still have an enjoyable time and be prepared."

The new survey was conducted by Mom Central, a one-stop web resource dedicated to providing busy moms with smart household and parenting solutions. Dey Pharma, L.P., a subsidiary of Mylan Inc. (Nasdaq: MYL) sponsored the survey. A total of 678 moms of children with a known allergy completed the online survey. The survey also found that:(1)

    --  61 percent of children have been prescribed an epinephrine
        auto-injector; however, only 23 percent of them carry it with them at
        all times.
    --  One in five moms is unsure how they feel about their school's emergency
        plans in place to deal with a severe allergic reaction.

    --  While many moms feel they have good information on food allergies, they
        also expressed a clear desire for more: 78 percent of survey respondents
        say they would benefit from additional information on food allergies and
        how best to prepare for and treat allergy-related medical emergencies.

"Parents of children with food allergies need to be vigilant throughout the year, and at Halloween when the temptation for sweet peanut-based or chocolate treats may be especially high. Even a child who has experienced a mild allergic reaction to foods in the past may be at risk for a more severe allergic reaction - or even anaphylaxis - in the future, so it's vital that every parent and child is prepared," said Dr. Phil Lieberman, Clinical Professor, Medicine and Pediatrics University of Tennessee College of Medicine. "Whatever you do this season, make sure you know if you or your child has allergies that are severe enough to put them at risk for anaphylaxis, and if they are, be sure to ask your healthcare provider if you or your child should have access to and carry an epinephrine auto-injector like EpiPen(R) Auto-Injector. In the case of an anaphylactic emergency, prompt administration of this medication can help save the child's life."

Tips for an Allergy-friendly Halloween

For parents of children with food allergies, monitoring Halloween candy is just one way to avoid an accidental allergic reaction. Stacy DeBroff from Mom Central offers additional tips for enjoying an allergy-free holiday:

    --  Find Allergy-Free Activities: With a little research, you can find many
        festive activities right in your own backyard.  Take the family pumpkin
        picking, on a hayride or for a scavenger hunt.

    --  Bring the Fun to Your Child: Consider hosting your own costume party for
        your child's friends.  Invite everyone over for pumpkin carving, bobbing
        for apples, spooky stories, a scavenger hunt and other Halloween-themed
        games.  This way, your child can still have fun and you can control all
        the goodies that are being passed out.

For those children who do go trick-or-treating, the American Academy of Allergy, Asthma, and Immunology (AAAAI) offers these helpful tips:

    --  Never Go Alone: Always accompany younger children trick-or-treating and
        have older children go out with friends.
    --  Inform Others: Make sure all the adults and friends in your group know
        about your child's food allergies and what to do in an emergency.
    --  Pack Medication: While out for Halloween, make sure you or your child is
        carrying an epinephrine auto-injector.  Make sure your child's friends
        or other adults know how to administer this medication.
    --  Provide Safe Snacks:  Provide your close neighbors and even your child's
        teacher at school with safe treats or even non-food items like stickers
        that can be given to your child.
    --  Check the Goodies: Carefully read labels or check the candy company's
        Web site to make sure the product doesn't contain something that can
        cause an allergic reaction. It's important to remember that the
        ingredients of 'fun size' candy bars may differ from the regular-size
        bars.
    --  When in Doubt, Throw It Out: If you can't find information on a treat's
        ingredients or are simply not sure if it's safe, then throw the candy
        away or stick it in a treat jar that is out of the reach of the child.

    --  Avoid Snacking: Eating dinner before trick-or-treating might curb your
        child's urge to sneak goodies from the bag.

About Food Allergies

Food allergies are three to four times more prevalent among children than adults and are a leading cause of anaphylactic reactions, causing an estimated 30,000 emergency room visits and 150 deaths annually.(2) Studies of deaths from anaphylaxis caused by food allergies have found that nearly half of all such deaths occur in children aged 10 to 19. Even though most of these children had known allergies to food, most of them were not carrying their self-injectable epinephrine or had never even been prescribed the medication.(3,4) Unfortunately, the vast majority of deaths from anaphylaxis occur in people who do not receive epinephrine in time.(5)

Learning More About Food Allergies

Parents of children with food allergies should consult their healthcare provider to learn more about the causes of allergies, possible medical treatments, and emergency action plans in the case of an anaphylactic reaction. Additional information about allergies and treatment can be found at the Center for Anaphylactic Support(TM) (http://www.epipen.com/CAS). The Center for Anaphylactic Support(TM) provides a range of free information and support services for people with severe allergic reactions and their caregivers.

About EpiPen

EpiPen(R) and EpiPen(R) Jr (0.3 and 0.15 mg epinephrine) Auto-Injectors are for the emergency treatment of severe allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for patients who are at increased risk for these reactions.

EpiPen(R) and EpiPen(R) Jr Auto-Injectors are designed for you to use immediately in an emergency, to treat an allergic reaction fast and help give you time to get to a hospital or medical center. EpiPen(R) and EpiPen(R) Jr Auto-Injectors are not a substitute for emergency medical treatment.

As with any medication, the EpiPen(R) Auto-Injector has an expiration date printed directly on the unit and shelf carton, and should therefore be replaced when the unit expires. The product should be stored at room temperature and never refrigerated or kept where it might be exposed to extreme temperatures, such as in the glove compartment of a car.

Dey Pharma, L.P., the worldwide distributor of EpiPen(R) Auto-Injectors, offers patient support through free membership in the EpiPen(R) Center for Anaphylactic Support (CAS) Program(TM). This program provides helpful tips, resources and an expiration reminder program. Information on how to join can be found on the patient insert dispensed with the product and by visiting www.epipen.com.

Important Safety Information

Each EpiPen Auto-Injector contains a single dose of a medicine called epinephrine, which you inject into your outer thigh. DO NOT INJECT INTRAVENOUSLY. DO NOT INJECT INTO YOUR BUTTOCK, as this may not be effective for a severe allergic reaction. In case of accidental injection, please seek immediate medical treatment.

Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.

Side effects may include an increase in heart rate, a stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These side effects usually go away quickly, especially if you rest. If you have high blood pressure or an overactive thyroid, these side effects may be more severe or longer lasting. If you have heart disease, you could experience chest pain (angina). If you have diabetes, your blood sugar levels may increase after use. If you have Parkinson's disease, your symptoms may temporarily get worse.

EpiPen and EpiPen Jr Auto-Injectors are intended for immediate self-administration as emergency supportive therapy only and are not intended as a substitute for immediate medical or hospital care.

See accompanying full prescribing information or visit www.epipen.com for full prescribing information.

Talk to your doctor to find out if you should be prescribed an EpiPen(R) and EpiPen(R) Jr Auto-Injector.

About Dey

Dey Pharma L.P., a subsidiary of Mylan Inc. (Nasdaq: MYL), is a specialty pharmaceutical company focused on the development, manufacturing and marketing of prescription drug products for the treatment of respiratory diseases, severe allergic reactions and psychiatric disorders. The company puts patients first and facilitates efficient, cost-effective partnerships with customers. For more information, please visit www.dey.com.

About Mylan Inc.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates the world's third largest active pharmaceutical ingredient manufacturer; and runs a specialty business focused on respiratory and allergy therapies. For more information, please visit www.mylan.com.

Forward Looking Statement

This press release contains statements that constitute "forward-looking statements", including with regard to the EpiPen Auto-Injector and the treatment of severe anaphylaxis. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the effects of competition; changes in third-party relationships; decisions by regulatory authorities; exposure to lawsuits; uncertainties and matters beyond the control of management; and the other risks detailed in the periodic filings filed by the Company with the Securities and Exchange Commission. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release.

DEY(R), EpiPen(R), EpiPen 2-Pak(R), and EpiPen Jr 2-Pak(R) are registered trademarks of Dey Pharma, L.P.

Center for Anaphylactic Support(TM) (CAS) is a trademark of Dey Pharma, L.P.

A(C) Dey Pharma, L.P. 2009. All rights reserved. Printed in the USA for USA residents only.

(1) Mom Central Survey, September 2009.

(2) Report of the Expert Panel on Food Allergy Research. National Institute of Allergy and Infectious Disease, National Institutes of Health, 2003. www.niaid.nih.gov.

(3) Bock SA, Munoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol. 2001; 107(1): 191-93.

(4) Bock SA, Munoz-Furlong A, Sampson HA. Further fatalities caused by anaphylactic reactions to food, 2001-02. J Allergy Clin Immunol. 2007;119(4):1016-18.

(5) Sampson H, Mendelson L, Rosen J. Fatal and near-fatal anaphylactic reactions to food in children and adolescents. N Engl J Med. 1992;327:380-84.

SOURCE Dey Pharma L.P.

http://www.dey.com

Copyright (C) 2009 PR Newswire. All rights reserved