Drug Update: New Medications 2012

1.             ProAir HFA will begin to become available with a counter for the number of doses of albuterol remaining located in the actuator during January of 2013.

2.             I have had an opportunity to try Dymysta.  I found it effective and to not having the burning postnasal drip I experienced with Astelin.

3.             Combivent Respimat will replace Combivent inhalers.  The new device does not use a propellent.

4.             Sanofi will launch a new product named Auvi-Q for delivering epinephrine subcutaneously for anaphylaxis.  This has a recording to guide its use which will be activated when the cover is removed.  The cost has not been announced yet.  Insurance coverage during the first year will not likely be good.  For comparison, Epi-pen 2-pack retails for $309 at CVS, when I checked last week.  My inspection showed a well designed product.

5.             Consumers may have noticed when they go to pick up Singulair at the drug store or receive mail order, they are given its generic montelukast.

6.             Gastrocrom is an oral preparation of cromolyn sodium and is indicated for mastocytosis.   This is a disease where mast cells release histamine in potentially fatal amounts.  The cost for a group of 96 unit dose ampules ranges from $459-1,000. I did not know the cost previously.

7.      Aerospan is flunisolide HFA 80 mcg and indicated for "maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age and older".  This Forest Pharmaceutical product was approved 1/26/06 by the FDA.  The label change was approved on 11/16/12.  No word currently from the new owner Action Pharmaceuticals.
8.     Tudorza is an orally inhaled dry powder of aclidinium which was approved by the FDA on 7/23/2012.  Aclidinium inhibits the M3 receptor so it is classified as an antimuscarinic, which are in turn grouped as anticholinergic.  This compound produces long-acting bronchodilation in patients with COPD.  Tudorza has not been launched yet.
9.     Generic Clarinex (desloratadine) was approved during the summer.  I just got confirmation from some patients that this given to them for refills, not the name brand.  Even recently, insurance companies have been pushing back to have the patient switched to a generic medication.  Note this means that there no oral name-brand only antihistamines available by either OTC or prescription now.
10.    Flucelvax is the first vaccine approved that uses a mammalian cell line not chicken eggs to grow the influenza virus.  Flucelvax was approved on 11/20/12 for both types A & B in patients >18 years old.

The Allergy Dude wishes you a Happy New Year!!

What do I need to know about Lice?

This post was prompted first by my wife, who works as a school nurse, and told me about seeing a boy who had to be treated for both lice and scabies at the same time, and next by a patient I saw, primarily for allergies, but then his mother asked me to look carefully at his hair.  There was a high suspicion of lice in my mind. 

 (Photo 1) More good photos are online.  We discussed the treatments: over-the-counter meds and prescription meds.  A good summary can be found at the CDC's website (although this site was last updated 11/2/10).  His mom asked me about using mayonnaise, which I never heard of.  The idea here is to suffocate the lice.  Some research led me to the Minnesota Department of Health's website.  I want to stress that any medication or home remedy must not be left on the person's scalp, because of the risk of irritating the skin, or causing a chemical burn.  The third and final thing that prompted me to write this post an announcement of a new prescription medication for lice: ivermectin.  You have to login to MEdscape to read the article, so if you can't then here's a pretty good summary on an open website.

Now for 2 obvious trivia questions: can anyone guess the origin of the phrases "to nit pick" and "to use a fine tooth comb"?

If you have questions about lice, ask your doctor....

What do I need to know about buying the best bread?

99% of my patients eat bread almost daily, which itself is not surprising, since we live in a westernized area with a very low percentage of Asians. Yet no one I've asked understands the facts about their bread.  It is a complicated problem.  This article is an attempt to educate all of us, including myself.

What is the definition of "Whole grains"?  This depends on who you ask.  I'll go with the U.S.D.A.'s definition in the "Dietary Guidelines for Americans 2010" listed in the Appendix page 36: "Grains and grain products made from the entire grain seed, usually called the kernel, which consists of the bran, germ, and endosperm. If the kernel has been cracked, crushed, or flaked, it must retain nearly the same relative proportions of bran, germ, and endosperm as the original grain in order to be called whole grain (here's a picture)."  For a short list of whole grains, I refer you to Table A4-3 on page 16 (and here in 2006 page 20).  For longer lists, I refer you to a list from the state of Idaho and Wikipedia.  In a 2006 U.S.D.A. report, they concluded that the average American should increase their consumption of whole grains by 248% (page 19) to fulfill the Dietary Guidelines.  The percentage of wheat in the product is not legally defined. 

I find the labeling confusing for all the types of whole grain wheat products.  The U.S.D.A does not have a definition for "multigrain".  This term has no formal definition anywhere that I can find.  Here's a commentary which lists other terms that are undefined as misleading, such as stone ground and 100% whole wheat.   Do not get up-sold by the words natural, light, healthy, stone ground or good in the label. On a positive note, groats "are the hulled grain of various cereals, such as oats and wheat." Think of cereals are the plants that produce the grains.  Which grain is the best to eat?  There is no consensus.  In an equally-sized serving, the number of calories, vitamins and minerals, plus other healthy nutrients varies widely.  Here's one person attempt at rating grains.

It is important to study the label for the ingredients, fiber content, sodium content, and serving size.  You can mislead yourself easily by making erroneous assumptions.  For example, check if the serving size is 1 or 2 slices of bread.  What you should know is that your bread is made from whole grains from whatever grain you like to eat.

Of all the grains, The Allergy Dude favors rice and oats.  I'll explain why in a future installment.

Healthy Eating: 1. Definitions

Introduction
The Allergy Dude has decided to write series of articles on healthy eating because the information available on the web is too scattered and variable, so he will select what he thinks is the most reliable and important information for his readers to help them understand his system for healthy eating.

1. Definitions
Please go to the following link for words defined in Connecticut's Action Guide for Child Care Nutrition and Physical Activity Policies. There are many lists on the web, but this list is the best one I could find, because it lists all of the terms that are important to my system.  Please read about: added sugars, artificial sweeteners, carbohydrates, chemically altered fat substitutes, cholesterol, complex carbohydrates, dietary fiber, enrichment, fiber, fortification, hydrogenated oils, monosaturated fats, natural cheese, nonnutritive sweeteners, partially hydrogenated oils, phytonutrients, polyunsaturated fats, saturated fats,

We can not have a meaningful discussion of my system without knowing these definitions.  They are very helpful for improving and maintaining your immunologic health.

2.The U.S. Department of Agriculture does not have a definition for a good or bad food.  On the other hand, it does have Dietary Guidelines for Americans.

3. In 1998, the U.S.D.A. defined antioxidants and named vitamins A, C, E, and the element selenium for further study.

The Allergy Dude will use these facts as the building blocks for more Healthy Eating in the next chapter.

Drug update and drug affordability advice

There has been a burst of news.  Let's get started, including some comments by The Allergy Dude!
 1. The FDA approved a combination product of azelastine (Astelin or Astepro) and fluticasone (Flonase) named Dymista.  Both ingredients are available individually.  There is no data supporting synergy.  This product could be convenient.  The Allergy Dude predicts that Dymista's success will hinge on the same factor as most other products, which is its price.  This is not known yet.  The product is slated to be launched during August.
2.  Omnaris (AQ) production continues to be too low, resulting in shortages.  There is no end in sight.  So if you want to fill a prescription, be prepared with an alternative.
3.  A new eyedrop for eye allergies called Lastacaft is being marketed.  There is no comparative data showing it is superior to other available products.
4. TEVA has been sampling its "new" nasal steroid product: Qnasl.  The more things change, the more they remain the same.  This is just like the no-longer-available Beconase and Vancenase sprays, except for two important differences.  First, each spray produces 80 mcg, not 42, of beclomethasone dipropionate.  Hence the dosing is 2 puffs once per day, not twice per day.  Second, the propellent is the same HFA is in the inhalers for asthma.  The Allergy Dude predicts that this product will have a niche in those patients who do not like the current aqueous formulations of corticosteroid sprays.  The only problems are the potential cost and the competition below.
5.  Omnaris HFA (Zetonna) is ciclesonide nasal steroid spray using HFA propellent.  Interestingly, no information can be found on Sunovion's nor the FDA website about the approval date.  There have been ads in allergy journals for months.  No word on the launch date. 
6.  To the best of The Allergy Dude's research, Singulair will not be available OTC after 8/3/12, but will be going generic.
7.  When the diagnosis of asthma remains in question after a careful history, physical exam, labs and spirometry, then a mannitol (Aridol) challenge would the next and definitive test.
8.  Studies by Merck for its sublingual (under-the-tongue) immunotherapy are closing and will be submitted for approval soon.  This means it is not available now and will not be available for 1-3 years more depending on the FDA's review, approval, and product manufacture.  
9. Daliresp is a new oral medication that may reduce the number of exacerbations of COPD in patients with severe COPD.

Affordability advice:
1. Concerning medications, Insurance companies are slowly increasing copays for medications, requiring prior authorizations, and issuing denials.  Keep track of which medications you have tried already.
2. At your doctor's office, ask for any coupons or rebates.  Within my office, The Allergy Dude is also known as The Coupon King, because I distribute so many coupons to patients.  Don't forget to use them, or you may be leaving money on the table.  If your medication is tier 2 or 3, you should seriously be searching for a coupon.  They are available more than you think.

3. Here is one example: Xopenex HFA's out of pocket cost is $66 but with a coupon card worth $75, it can be free.  You can't file through insurance though, because it was out-of-pocket.4. Another slightly different example: Alvesco's out-of-pocket cost is $122 but with a coupon card worth $75, you still pay $47.  If Alvesco is tier 3 on your insurance formulary, for which you pay $50, then using the coupon card gets you the Alvesco for free. 5. Read the coupons carefully.  For example, a Veramyst coupon offers $25 off, which helps, but only once, as is stated on the coupon. 6. Consider doing a drug study.  Often the participants may get paid for their time and effort, medications, and medical care & tests during the period of the drug study. It's not a bad option for those with high deductible insurance, those trying to get a medication they can't afford, or those wanting to try a new medication. That's the news and views from The Allergy Dude aka The Coupon King.

Olive oil points in favor

The Allergy Dude was going to summarize some of his reading about olive oil, when he realized that once again wikipedia has beaten him to the punch again.  No matter, give credit where credit is due.  The retail grades of olive oil should be scrutinized.  The labels can be very confusing and vary from nation to nation.  Nevertheless, The Allergy Dude endorses using monounsaturated fats in your cooking as a step towards a healthier diet.  Olive oil contains by far the highest amount of monounsaturated fats by weight (75%) of all vegetable oils available.  Sunflower oil and peanut oils come close depending on the variety, which alters the content of monounsaturated and polyunsaturated fats.

Are there anti-oxidant vitamins to treat allergies or asthma?

My father asked The Allergy Dude recently this question.  What about vitamin E?  Some small trials and retrospective studies have been done to investigate if vitamins can reduce the signs or symptoms of allergic diseases.  The short answer is NO, unfortunately.  In some other diseases, the answer can be yes sometimes.  For example, in age-related macular degeneration (AMD), in moderate and severe cases, the vitamins and mineral zinc helped to prevent further losses.  This link explains the findings of a multi-center trial very well.  AMD involves the retina, which is located in the back of the eye.  Cataracts are located in the lens of the eye, which is in the front, to clarify.  Cataracts are not prevented or slowed in development by any vitamins or minerals. If you know some one with AMD, please share this fact with them.

Do hypoallergic pets exist?

Today's article is completely based on an article by Butt, Rashid and Lockey (in Ann Allergy Asthma Immunol 2012; 108: 74-6) titled "Do hypoallergenic cats and dogs exist?" The Allergy Dude gets asked about this frequently and he apologizes for not having an posting about this until now.  (No summary is available on PubMed.)  Their article reviewed the scientific evidence available about hypoallergenic dogs and cats.  First, why is this important?  17% of cat owners and 5% of dog owners are sensitized to their pets' dander.  We recognize that cat dander is generally more likely to cause allergies than dog dander.  Daily exposure to dander can significantly contribute to an increase in a patients' signs and symptoms of allergies both perennially and seasonally.  The vast majority of pet owners keep their pets despite being advised by their allergists to keep the pets outside of the house.  Many let the animals sleep in the bedroom.  Pet owners ask about available measures to reduce the accumulation of dander in the house.  No measures for bathing pets, or house cleaning, even using a vacuum cleaner with a HEPA filter, or having multiple HEPA air filtration devices can remove all of the dander shed by their pets.  The amounts of dander can be reduced.  My analogy is it's like walking up an endless sand dune.  It's hard to get ahead and it's a good bit of constant work in our already-too-busy lives.  Back to the article, despite the claims and endorsements on some companies website, multiple allergy associations have concluded that no evidence for hypoallergenic exists. The Allergy Dude completely agrees with this conclusion.  Sorry pet owners.  If this changes, as in incontrovertible evidence does become available, after The Allergy Dude invests heavily in said company then he will update this blog.