Drug Update: Patent expirations of Levaquin, Singulair, Avelox and Xyzal

Happy New Year to all of the Allergy Dude's readers!

Let's review 2011 first.  No branded products were removed from the market, which is good.  Due to an earlier decision by the F.D.A., generic combinations of antihistamines and decongestants will not be available by prescription in the U.S.  The Allergy Dude can not vouch for medications bought outside of the U.S. since there may be issues about "who is responsible quality control of the product?".

Two quiet changes are that first Levaquin's patent expired on 6/20/11.  This is now available as a generic.  Second, Avelox's patent expired on 12/18/11.  This is not available as a generic to my research as of today yet.  This may change.

A reminder that Xyzal has been available as a generic in the 5mg pill (only) since December of 2010.  So this left only Clarinex as the only branded antihistamine on the market.

A gigantic change is coming in 2012 because Singulair's final patent will be expiring on 8/3/12, as I outlined in an earlier post.  This is spell financial relief for many patients and their families.  Note there has been no discussion about Singulair going over-the-counter.

One final note, Xopenex will be a branded product until the last of its 5 patents expires in 8/13.

Have a good year!!!

Greenville (South Carolina's) Rank as an Allergy Capital Fall 2011

Here is how Greenville, South Carolina has been ranked in the Asthma and Allergy Foundation of America's lists of the top 100 most challenging places to live in the U.S. for: Spring Allergies, Fall Allergies, or Asthma.

 

Year	Spring Allergy rank	Fall Allergy rank	Asthma rank
2003	13	24	not done
2004	19	34	54
2005	6	32	58
2006*	2	1	68
2007	53	45	34
2008	17	2	8
2009	25	96	49
2010	28	44	59
2011	20	31	83

updated 12/13/11.

* = A good or bad year for us, depending on your perspective!

Commentary: Most of the top 50 cities in the Allergy Capitals lists are in the Southeastern U.S. The likely explanation is the highest pollen counts occur in the Southeastern U.S., because of the longer and warmer climate + greater vegetation which cause more allergies and so more medication use. These are two of three criteria used to determine the rankings. The table above can not be found in this format anywhere else on the internet.

If you are curious about how other cities were ranked this year only, go to the Allergy and Asthma Foundation of America's website or click on the link in the top left corner of this website. Prior year's rankings can be found by searching the internet. To see graphs of this years' pollen and mold counts, click here.

Addendum: 4/24/11
I disagree with the 3 measurements used to determine their rankings of Allergy Capitals:

• Pollen scores (airborne grass/tree/weed pollen and mold spores)*
• Number of allergy medications used per patient
• Number of allergy specialists per patient.

Many of the cities in the rankings do not have any pollen counting stations.  How then are their pollen scores calculated?  They must be estimated.  This is 33% of their score.  This greatly affects the rankings.  Physicians are humans also and so tend to live in larger cities and nicer areas.  This may boost the rankings of these cities.
Separately, Greenville ranks about 20th in the spring and about 42nd in the fall fairly consistently.The pollen counts are higher in the spring than in the fall, as it is for most of the SE US.
12/13/11 My other objection to the list is: how are the pollen and mold counts determined?  My office has been responsible for the pollen counts in Greenville since 2000.  We don't publish mold counts, because we use a Rotorod sampler, which does not count mold spores accurately.  Almost every site listed in the National Allergy Bureau's website uses the same sampler (private communication).  I also know the NAB does not monitor 100 other pollen and mold counting stations.  So where does the certified data come from?  I happen to have lived in Dayton, OH and I know the pollen counts weren't as high as Greenville's.  Perhaps the climate and vegetation has changed.

Influenza Vaccination for the 2011-12 Season

The Centers for Disease Control and Prevention published their guidelines for administration of the influenza vaccination for the 2011-2 season.  So The Allergy Dude will just summarize.

1.  The vaccine is the same as the vaccine from 2010-1, because they thought the flu strains were going to be the same.

2.  The vaccine contains 3 strains of influenza, one of which is H1N1 or swine flu.

3.  One vaccination is expected to provide immunologic protection for the entire flu season, so a booster is not necessary.

4.  Any patient aged 6 months old or more should consider receiving the vaccine, unless they previously had a life-threatening adverse reaction to a prior flu vaccine.

5. Patients with a history of an egg allergy should have the diagnosis confirmed.  The influenza vaccine may still be given, however the setting must be where the medical staff can provide medications needed for life-threatening reactions.  The odds of a life-threatening allergic reaction to the very tiny amounts of egg protein in influenza vaccines is very low.

Just in case you are wondering if I practice what I preach, here I am getting my own medical advice.

Food Allergy and Adverse Reactions: More Information

The combination of seeing some patients recently with suspected allergies to additives and recently published articles have led me to dedicate this entry to further education about food allergies.

1. What is "natural"?  The United States Department of Agriculture Food Safety and Information Service have a good list of definitions.  For meat and poultry, "A product containing no artificial ingredient or added color and is only minimally processed."

2. What about "hypoallergenic"?  The F.D.A.'s only statement on its definition applies to cosmetics, not foods. There are "no Federal standards or definitions. "The term means whatever a particular company wants it to mean." So the careful reader should become wary when reading this term.

3.  Can I rely on food labels?  Short answer: no, may be.  The FDA does have general guidelines.  In 2006, the Food Allergen Labeling and Consumer Protection Act became in effect. Eight of the commonest allergens were required to be listed on the labels if those eight allergens were even potentially present at any stage in the manufacturing of any ingredient in that food.  The intent was to help patients avoid them.  The eight allergens are: milk, eggs, fish, shellfish, tree nuts, nuts, wheat, and soybeans.  This has been effective.  BUT if a patient is allergic or has adverse reactions to other substances in foods, food labels can NOT be relied on.  Items for food processing, such as gelatin, do NOT have to be listed on labels, per the FDA, because they are deemed to have no effect on the food or be present in only trace amounts.  Unfortunately, trace amounts can be enough to trigger allergic reactions in highly sensitive individuals.

This is not to say that processing aids are not regulated.  They are and are defined clearly by such bodies as the European Union, FDA, and the Canadian government.

4. What else are in foods, besides foods?  Lots.  The FDA maintains a list of over 3,000 approved ingredients.  The categories include: preservatives, sweeteners, color additives (commonly called dyes), flavors and spices, flavor enhancers, fat replacers, nutrients, emulsifiers, stabilizers and thickeners, binders, texturizers, pH control agents and acidulants, levening agents, anti-caking agents, humectants, yeast nutrients, dough strengtheners and conditioners, firming agents, enzyme preparations, and gases. 

5. Have food dyes been linked to behavior problems in kids?  The short: no, but suspected.  This is a common topic in the media.  Here's a story on National Public Radio.  The FDA's stance is that food dyes, for they refer to them as color additives, are regulated and generally very safe.  In researching this, I learned some interesting facts.  There are only 7 artificial colorings approved plus 2 more for limited indications, in foods.   There are 2-3 dozen approved color additives for drugs, cosmetics, and medical devices.


6. Is it completely safe to eat in restaurants if they post or list all of their ingredients?  No, and this is not a knock against restaurants or food preparers.  The issue is called cross contamination, which means the transfer of harmful substances to foods.  This is inadvertent, but still a risk that depending on the severity of reactions must be considered.

What is the Difference between the Cold Desserts: Ice Cream, Gelato, Sorbet, Sherbet, Italian Ice?

The Allergy Dude was asked by the mother of a patient today since he has egg and milk allergies what kind of cold desserts he could eat?  What about gelato?  Good questions.  The Allergy Dude confessed he did not know the exact differences between cold desserts (ice cream, gelato, sorbet, sherbet, Italian ice).  Do you?

Here's the answers, courtesy of Wikipedia:

Let's start with what is  (1) ice cream.  It is a mixture of milk and cream, salt, flavors, sweeteners, sometimes fruits, a small amount of egg yolks.  Note, the exact definitions of each dessert depends on the country.  For example, in the U.S., the Food and Drug Adminstration has a strict guideline to distinguish between ice cream and (2) frozen custard.  (Yes, believe it!)  The latter "must contain at least 10 percent fat milk fat and 1.4 percent egg yolk solids.  If it has fewer egg yolk solid, then it is considered ice cream."

Now for the rest of the field. (3) Gelato originated from Italy and is similar to ice cream.  Two differences are gelato typically contains lower 4–8% butterfat, versus 14% for ice cream in the United States, and dairy based gelato contains 16–24% sugar whereas most ice cream in the United States contains 12-16% sugar.

(4) Sorbet contains the same ingredients as gelato except no diary products.

(5) Granita is a "semi-frozen Italian dessert made from sugar, water, and various toppings".  It is very similar to

(6) Sherbet is "a fizzy powder, containing sugar and flavoring, and an edible acidic and base."  When the powder comes into contact with water from a mixing or from saliva, the acid and base react and produce the gassy bubbles.  Examples on the U.S. include Pixy Stix and Pop Rocks.

(7) "Italian ice, or water ice, is a sweetened frozen dessert made with fruit (often from concentrates, juices or purées) or other natural or artificial food flavorings."  The ingredients are frozen while mixing them, like ice cream.  It does not contain diary or egg yolk, which sherbet may.

(8) Shaved ice is fine ice crystals with a topping added .  In North America, this is also called a (9) snow cone.

(10) Slush is "a flavored frozen drink".  It is a name for a group of desserts made by freezing a liquid.  Examples include Slurpee and ICEE.

(11) "Semifreddo (Italian: "half cold") is a class of semi-frozen desserts, typically ice-cream cakes, semi-frozen custards, and certain fruit tarts."   Gelato is often used.

(12) "Frozen yogurt is a frozen dessert containing yogurt or other dairy products. It is slightly more tart than ice cream, as well as lower in fat (due to the use of milk (only 0.5-6.0%) instead of cream)."

(13) "Soft serve is generally lower in milk-fat (3% to 6%) than ice cream (10% to 18%) and is produced at a temperature of about −4 °C compared to ice cream, which is stored at −15 °C. Soft serve contains air, between 33% and 45% of volume, introduced at the time of freezing and which affects the taste of the finished product.  More than this and the product loses taste, tends to shrink as it loses air and melts more quickly than that with less air."

(14) "Dessert mousse is a form of dessert typically made from egg and cream (classically no cream, separated eggs, sugar, and chocolate or other flavorings), usually in combination with other flavors such as chocolate or puréed fruit."

For me, fine dining will never be the same.  As for the mom, she and her daughter will have to be careful about which cold dessert she eats.  Are you ready for the Allergy Dude's quiz?

Nasal endoscopy

The Allergy Dude may recommend nasal endoscopy for some patients to better examine the nasal cavity and throat.  Some times directly looking with the eye and a small magnifying glass is insufficient.  Having a brighter light that can be directed around corners is very useful.  The nasal endoscope is about the size of a small black spaghetti noodle.  About 10-15 minutes after an anesthetic and decongestant is sprayed into the nose (read Afrin + Lidocaine), the endoscope can be easily introduced into the noses of most people.  It's quite tolerable.  I should know.  I was the guinea pig for my allergy program that every one practiced on.  I even had to practice on myself.  The Allergy Dude has found two good videos on youtube that demonstrate nasal endoscopy 1, 2. 

(Endoscopes are very useful and come in larger sizes.  They may also be used to look inside of the stomach or into the colon.)  Endoscopes also allow us to look at the throat and vocal cords.  Hypothetically, you should have a nasopharyngeal endoscopy at least at the initial visit and at followup visits when needed.  Why are they done?  Patients refuse or the physicians do not think the detailed exam is indicated.  But keep this in mind if regular medical treatments fail to provide relief.

What does it mean to be Red Flagged for a Prescription?

Today, the Allergy Dude will write about a potentially delicate topic: being red flagged for a prescription at your pharmacy.  Since 2002, the U.S. Department of Justice has offered a grant to states to support the planning, implementation, and enhancement of a prescription drug monitoring program (PDMP).  According to the Drug Enforcement Agency (DEA), as of May of 2011, 35 states have established their own PDMP and the remaining states territories are planning to have a PDMP.  South Carolina happens to be in the former group.  The website providing information is part of the Department of Health and Environmental Control.  The express purpose is to monitor prescriptions of controlled medications.  Pharmacies and physicians now have a source to check that patients who request prescriptions of controlled substances, especially for either large quantities or frequent refills, are not abusing the health care system.  If there is suspicion, then those patients have a "red flag" placed next to their name, to warn the providers and pharmacists.  This is not literal, since every one uses computers these days.  Unfortunately, abuse of controlled medications is a fact of life.  This mechanism helps to reduce this unpleasant problem.  Even in my office, an allergist's, there is occasional need to access that website to check up the patient's history of prescriptions and from which doctor and pharmacy.

The purpose of Allergy Dude's entry today is to provide more facts to those that are searching for answers on the internet about "red flags".  I had to do some searching myself for documented answers.

Should I eat white rice or brown rice?

The Allergy Dude will write about which kind of rice is preferred to eat: white or brown.  First, I'll tell you what I do not think you should eat: any fried rice from restaurants.  Normally restaurants use animal lard for the cooking oil.  This overwhelms any nutritional benefit from eating rice.

Next what is brown rice?  Starting with a rice grain, once the husk is removed, you have brown rice.  Then after the bran and germ are removed, what remains is the white endosperm.  This is the white rice you buy in stores and eat.  The endosperm has nutritional value, however so do the bran and germ.  The nutrients in the latter include rice bran oil, fiber, vitamins, and minerals.  Thus brown rice has more nutritional value than white rice.  If you compare labels, remember that white rice has nutrients added back into the package.

A large study of almost 200,000 people in the U.S. by Qi Sun concluded that "eating two or more servings of brown rice weekly seems to be associated with a lower risk of developing type 2 diabetes". On the other hand, they reported, "eating five or more servings of white rice per week is associated with an increased risk."  White rice has a higher glycemic index than brown rice, which means that blood sugar levels rise faster after eating white rice than brown rice.  This is thought to be from the greater fiber content of brown rice.  A 2011 small study from China did not find any difference in rate of developing metabolic risk factors for type 2 diabetes.

Here are some other aspects of brown rice.  Since brown rice contains more grain than white rice, brown rice takes longer to cook. Brown rice has to be stored more carefully, because the oil in the husk can age and produce a rancid taste.  Brown rice has more calories than white rice, but remember the calories come from higher fiber content.

 

Lastly, brown rice costs paradoxically about twice as much as white rice.  You might think that since brown rice is less processed than white rice, which also has nutrients artificially added, that brown rice should cost less than white rice.  The simple reason is economics and habits.  Just like with white bread and wheat bread, nearly the entire universe prefers to eat white rice, so the demand has shaped the system to produce white rice inexpensively.

The Allergy Dude therefore recommends his readers avoid eating fried rice from restaurants and when possible try to eat brown rice versus white rice.  And yes the Allergy Dude puts his money where his mouth is and also tries to eat brown rice whenever possible rather than white rice.  It is not easy, since the Allergy Dude was raised eating white rice, but free will and intelligence decide that active energy must be expended to have a better outcome.