GLG News by David Engler, MD

Implications: If this isn't fixed, it won't be long before cognitive specialties, like internal medicine and neurology, start capping their practices and not allowing new Medicare patients.    

Analysis: If that happens, the seniors and the AARP will raise heck.  I predict that this problem will be solved by the end of the month.  If they don't, the backlog of claims and the need to re-process all those claims next year with the add'l 10% payment will be too expensive to process.

Implications: Here comes a prescription version of generic Zyrtec syrup.  At first glance, we wonder how it will compete with over the counter Zyrtec.  But wait...there may be a market for this drug    

Analysis: Here's a couple of "what if's"...
1)  What if the patient has great insurance coverage that includes antihistamines?

2)  Currently, OTC Zyrtec is ~ $1.00/pill for Zyrtec brand pills, and just over $1.50/24 hour supply of the liquid for an older child.  That's >$45.00/month.  If this one has less out of pocket cost...

3)  Generic Zyrtec pills are as cheap as 5 cents each, but you don't see generics of Zyrtec liquid.

Implications: This drug seems much more effective at reducing free-IgE levels than is Xolair.  Overall, Xolair has given many patients a tremendous improvement in their quality of life, but it hasn't fulfilled many of its promises. Frankly, some of Xolair's benefits are disappointing, particularly in the 40 or 50% of patients who use it without achieving great results.  In particular, Xolair patients who are on Advair 500/50 can sometimes get down to Advair 250/50, but it's been difficult tapering them to lower doses of inhaled corticosteroids.

Analysis: One of the problems with Xolair is that it an antibody to all IgE.  Future generations of monoclonal antibodies directed against IgE will be designed to act only against dust mite IgE.  Or cat IgE.

Or, if we're really lucky one day, against PEANUT IgE.  The study that was published on Xolair and peanuts showed that those allergic to peanuts increased their tolerance from 1/2 of one peanut to 9 peanuts.

Though a discernable difference, it is not exactly what we were hoping for.  Another company, Tanox, was working on another anti-IgE specifically to fight peanut allergy.  According to a Texas Monthly article from the mid-1990's, Genentech (DNA) stole Tanox's anti-IgE ideas, then ending up buying Tanox after wearing them down in court.  And then Genentech shut down the research involving Tanox's unique approach to anti-IgE, and made no further plans to investigate peanut allergy with Xolair.

OK, back to this improved anti-IgE.  If an asthma biotech drug is going to cost a couple thousand dollars a month, it's reasonable for us to expect it to work pretty well; either significantly improving quality of life, reducing visits to the E.R., and reducing the need for potentially harmful high-dose inhaled corticosteroids.

 The classic Xolair study showed that you could decrease an asthmatic's use of inhaled steroids.  But guess what?  The steroid they had patients using in that study was beclomethasone.  That's right, they didn't use fluticasone or budesonide or any of the high-potency inhaled steroids.  They used the equivalent of a Model T.  Instead of a modern Mercedes-Benz or BMW, they used an old Ford Model T.  They had to do that because they wanted the results to be clinically significant, with a p-value <.05.

So, in summary, we all know that Xolair is the first of many biotech drugs to come out of the gate to treat severe asthma.  While it has been helpful in many patients, the market is ready for new, improved versions of anti-IgE.  Especially one that needs to be used exactly one time, and one time only---Xolair must be used once or twice per month, indefinitely.

Implications:  A bottle of 30 Generic Zyrtec can be purchased for $15.  No one is going to get Xyzal that inexpensively. There are no head to head studies showing Xyzal to be better than Zyrtec.  Even though Xyzal claims a 6% sedation rate compared to Zyrtec's 14% rate, it's not apples to apples.  In the Zyrtec study, placebo made 8% sleepy, whereas placebo only made 2% sleepy in the Xyzal study. Thus, either way, the drug was much more sedating than the placebo.

Analysis:

 

Xyzal is no better than other antihistamines for tough to treat hives (urticaria).  What is an example of tough-to-treat hives?  How about familial cold urticaria.  When it gets cold, these poor folks get itchy hives popping up all over.  An old drug, Periactin, is about all that works.  Singulair was supposed to help a little, but doesn't reliably. Now comes Xyzal, telling us it's the best antihistamine ever.  After all, Xyzal is based on Zyrtec, and Zyrtec beat Allegra in each and every quantitative competition (where they saw which one inhibited allergy skin tests the most)         

But Xyzal suffered a knockout punch by all three of my familial cold urticaria patients.  It worked no better than Zyrtec, Allegra or Claritin.  And all of those are available as Generics.   

Implications: Use of Asmanex will continue to increase with this approval down to age 4. Its dose counter tells you exactly how many doses are left in the device.  Pulmicort uses a system that counts down 120---90---60---30---0. A lot of patients on Pulmicort complain to me about this "approximate" dose counter.  Also, Asmanex is easier to use than Pulmicort , but you get less for your money. Pulmicort 180 gives you 120 doses in each cannister; Asmanex only gives you 30 or 60.  Therefore, a Pulmicort prescription will last a patient two months unless they're taking 4 puffs per day. With the recent possible bad news about Singulair and suicide, parents may be less hesitant to try inhaled steroids.  Especially if their child with asthma already has a brittle psychiatric history.

Analysis:  I trained as a post-doc in allergy & immunology from 1989 - 1991.  Back then, "triple drug therapy" for asthma, as defined by primary care docs who sent us patients, was theophylline time released, albuterol tablets, and inhaled Proventil or Alupent.

Over the past 5 years, though, more and more patients, including young children, are being referred who are already taking inhaled steroids as their "asthma controller".

It is a big step to convince an asthmatic's parents that steroids are necessary, but a 3 minute talk will usually get the message thru well.  During this talk, I mention that Asmanex is 200 mcg per puff, whereas Prednisone syrup is 15 mg per teaspoon.  The "c" in mcg means we're talking about MICROgrams, not MILLIgrams, and that there are 1000 mcg in each mg.

The next step is telling them that our adrenal glands produce about 5 mg of steroids each day, so one or two puffs of Asmanex per day stays under 10% of what we already make.

Most parents are comfortable with that explanation

Schering Plough has bigger problems than Asmanex at the moment; just today, the NEJM article was officially published stating that Vytorin was no better than generic Zocor. 

Apparently, Zetia and Vytorin represented 60% of SGP's recent profits, and the headlines today are layoffs at SGP.

It's still true that Advair is the 800 lb gorilla for asthma treatment, but plain steroid inhalers like Asmanex work fine for most patients without including a long-acting bronchodilator, as Advair does.  More background on the safety of Advair is on my web site here.  Make sure to click on the first link to see Dr. Martinez abstract from a New England Jour Medicine article from December, 2005.

Implications: It is difficult to imagine why taking Singulair would increase the risk that someone would complete suicide.  After all, what does a leukotriene receptor antagonist have to do with mental health?  I don't know. But doctors, ask yourself, have you ever had a Singulair patient stop taking it because it caused headaches?  I have had dozens of them stop taking it because of headaches.  When they attempt to try it again, the headache comes back.  But the package insert says that the risk of headache is no greater than it is in people who took placebo. Try explaining that to the patient who got the headache--it's very real to them.

Analysis: The story about Singulair and suicide may be based on some cause-effect relationship.  I don't know what that is, but I will tell you story of a patient I saw last week.  She is a 19 year old college student, with the usual stresses of college.  I have been treating her for asthma and allergies since she was 10 years old, and she had been on Singulair for about 5 years.

She was treated in the town's ER for an intentional Tylenol overdose; she took 15 of them for a headache that wouldn't go away.  The usual charcoal to the stomach, with Mucomyst to protect the liver from the Tylenol went fine.   While under evaluation, the ER doc also noticed she had been "cutting" her wrists and arms.  She said that it relieved stress.

They asked her about the Singulair and she said it gave her bad dreams.  Astutely, they stopped it.  All this happened a week or so before the recent news headlines.

Is that cause and effect?  No way....but remember that MRK is the same company that still denies that Vioxx can increase the risk of heart attack.  Oh yeah, Vioxx.  That drug would have been great as a niche drug if given to treat pain in those already at risk of a GI bleed.  But, no, MRK was encouraging dentists to give it out for toothaches, and most patients in my practice who were on it had no history of GI bleed.  MRK wanted Vioxx to be a billion-dollar blockbuster; had it been marketed appropriately, it may still be on the market.

So how will I change my prescribing habits?  For patients who have a psychiatric history, including those who take antidepressants, I'll mention the story of this patient to those on Singulair and start asking questions to try to determine if they are brittle or fragile from a psychiatric standpoint.

This may be much ado about nothing, but what if it's not?  I've learned to stop drinking the drug company Kool Aid without a few grains of salt.

Implications: State of the art care for asthma over the past 20 years has involved giving the patient steroids to treat "late phase asthma", the mucus, edema and inflammation that happens on the INSIDE of the airways. Alvesco is different from every inhaled steroid that has come before it.  It is less likely to cause steroid side effects.

Analysis:
Prior to the late 1980's, doctors were busy treating "early phase asthma" with many drugs.  Sometimes, a patient would be on Triple Drug Therapy.  Wow, sounds intense.  But it was, in retrospect, not valuable. 

After all, these were 3 early phase drugs:  albuterol pills, theophylline, and albuterol inhaler.  Not that it helped more than one of those drugs.  At least not until the doctor gave the patient a steroid (cortisone) shot.  That allowed some Rx of the "late phase", as described in paragraph one.

The problem with those cortisone shots, or cortisone pills (Prednisone, Medrol, methylprednisolone) is they have lots of side effects.  Using 0.1% of that dosage in a topical spray, delivered right to the target organ (the lungs) was a better idea.  And we got lots of new asthma sprays: Beclovent -> Azmacort -> Flovent -> Pulmicort -> Asmanex, as well as Advair and Symbicort.

But, in order to be effective, it's necessary to use those drugs every day, year after year.  That's because these low-dose, inhaled steroids are strong enough to PREVENT asthma symptoms, but not strong enough to treat them.

Using the inhaled steroids only when you need them is about as smart as a woman taking the birth control pill only when she "needs" it.

And year after year, those microscopic doses add up.  We can say without question that use of Pulmicort 180, 2 puffs twice a day, or Flovent 220, 2 puffs twice a day, puts someone at increased risk for osteoporosis, cataracts, and a few other flavor of the month steroid side effects.

Now comes Alvesco, which is not a steroid until it arrives down in the lungs.  That means that when you inhale Alvesco, and 80% of the drug lands in your throat while maybe 10-20% actually gets down to the lungs...that 80% in the throat, then the stomach, does NOT count as total steroid dose for the patient.  This is a very good thing.  For asthma.

Not for allergic rhinitis.  ciclesonide, the drug Alvesco is made of, also is being developed as Omnaris, a nasal steroid to compete with Nasonex and Flonase.  Now why someone who want to mess with a honeybee played by Antonio Banderas is besides me, but that is Omnaris' task.  The problem is, nasal steroids are dosed at about 20% of the asthma dose. 

If someone uses 1 puff of Asmanex twice a day for asthma, they get 440 micrograms (0.44 milligrams) of mometasone, its steroid.  If they're on 2 puffs twice a day, they'll get 880 micrograms.

If they use Nasonex, 2 sprays in each nostril once a day, they get 200
  micrograms of mometasone. 

The daily dose which starts to concern is above 600 or 800 micrograms.  200 micrograms is pretty insignificant.  So Omnaris will not do very well, in my humble opinion.

But Alvesco should do pretty well.  I already have about 50 patients I plan to put on Alvesco as soon as it's available and in my sample closet.

After Alvesco, ciclesonide will team up with a long-acting beta agonist (e.g., salmeterol = Serevent  &  formoterol = Foradil) to make a competitor for Advair and Symbicort.

Again, that is an idea worth considering.  I'm excited.

Implications: Key Points of this article: 1)  CFC helps destroy the ozone layer in the stratosphere 2)  CFC albuterol is being banned in 2008 3)  CFC-containing metaproterenol (Alupent and generics) will still be available 4)  CFC-containing Combivent (albuterol plus ipratropium) will still be available 5)  Over the counter Primatene Mist (epinephrine) will still be available 6)  Maxair Autohaler (Pirbuterol) will still be available

Analysis: Bonus:  Clinical Pearl from this article--Warn your patients using Proventil HFA (but not Ventolin HFA or ProAir HFA) that using the Proventil HFA just before a breath alcohol exam by the police can result in a false positive reading.  According to the article, a bit of alcohol is present in the Proventil brand.

Otherwise...some patients just don't like the way that the HFA inhalers feel.  They're not as cold, and they don't hit the back of the throat as hard as the old CFC inhalers do.  For those patients, you will still be able to prescribe asthma rescue inhalers for a undetermined period of time:  CFC-containing Alupent, Combivent and Maxair.

Implications: Take Zyrtec and sort out the right-handed molecules from the lefties.  Send all the lefties home, and you have levocetirizine, a.k.a. Xyzal.  Like Zyrtec, Xyzal is owned by UCB http://www.ucb-pharma.com/products/ .  But unlike Zyrtec, Xyzal will not be marketed by Pfizer.  Instead, UCB has enlisted sanofi-aventis, the company that brought Seldane, and then Allegra, to market        

Analysis: Nowadays, Allegra has gone generic, but sanofi-aventis continues to promote Allegra-D 12 hour and Allegra-D 24 hour.  (The 'D' products have pseudoephedrine <Sudafed> added, to help treat stuffy noses and sinus pressure)

In another month or so, they'll still have those 2, but they'll also have Xyzal!  Maybe they'll sell off the Allegra line when Xyzal gets a Xyzal-D?

How unusual.

Is Xyzal an improvement over Zyrtec?  Not really.  Maybe it's a bit less sedating than Zyrtec, but the bottom line is, both Zyrtec and Xyzal have a better chance of making you sleepy than placebo, and that will hurt Xyzal.

A few years ago, The Medical Letter, a well respected review of drugs, said that Allegra was the best overall choice of antihistamines.  It is stronger than Claritin or Clarinex, almost as strong as Zyrtec, and won't make you sleepy.  These days, it's available as a generic, and that's why generic Allegra (fexofenadine) is the #1 antihistamine I prescribe.

Meanwhile, if Claritin works for you, get it as cheaply as you can.  It's generic, loratadine 10 mg, is available in bottles of 300 pills for $11.00 at Sam's Club or Costco.  That's about 3 cents per pill.

Implications: Levoceterizine is the left-handed isomer of ceterizine (Zyrtec).  It gives all the antihistaminic effect of Zyrtec with, maybe, half the sedation.  But it ain't non-sedating!  Look at its own data:  6% sedation with Xyzal, 2% with placebo.  As such, I must respectfully disagree with one of my colleagues on this board who described it as 'Zyrtec without the side effects'.

Analysis: However, this drug will have some utility.  As for my other colleague who compared the efficacy of Zyrtec to the efficacy of Claritin (loratadine) and stated that Claritin is "...just as effective".

 Well, about 99% of my patients who take Zyrtec currently would disagree.  Those patients use Zyrtec because nothing else worked.  Not Claritin or Clarinex.  Not even Allegra. 

Zyrtec data from several years back proved its superiority over Allegra with skin testing studies.  As an allergist, there is no better way to measure how strong an antihistamine is than by seeing how well it will prevent allergy skin tests from showing up.

So, for every one of my patients who got sleepy taking Zyrtec, but whose symptoms don't respond adequately to Allegra, Clarinex, Claritin, Benadryl, ChlorTrimeton, Tavist, etc...I think I'll let them try Xyzal. 

For the other 97% of my patients, I'll continue them on generic Allegra (fexofenadine)  or OTC Claritin (loratadine).  Especially when Costco and Sam's Club sell generic Claritin for less than 5 cents a pill, and fexofenadine's generic price will fall every 6 months for the next ten years.

Implications: This is one of those studies where the marketing department calls us research and says, "Here's the conclusions to your next study.  Now design and perform a study to reach these results and this conclusion."  Unfortunately, I'm not kidding, and doctors aren't fooled.

Years ago, Astelin designed a head-to-head trial against Beconase AQ and Claritin and was ruled more effective than that combination.  The problem was, Beconase AQ had already been replaced by the more powerful Flonase and Claritin was the weakest antihistamine in a group that included Allegra 60 mg and Zyrtec 10 mg.

But Astelin is a good "sixth man," to borrow a phrase from March Madness and the NCAA basketball tournament.  If a patient uses daily Nasonex and Singulair, but they still have symptoms, we often recommend Astelin as a stop-gap measure to help out.    

Analysis:

Astelin has some advantages: 
1)  Unlike Clarinex and Allegra and Zyrtec, it doesn't require pre-authorization.
2)  It goes for a Tier 2 co-pay on almost all plans, whereas those ^ antihistamines often require a Tier 3 co-pay or are non-formulary.
3)  It has a rapid onset of action since you're applying it to one of the target organs.

However, many patients can't deal with horrible taste.  They call this drug, "Nastylin".

In order to minimize the taste issue, it's very very important for the doctor's office to teach the patient to inhale the drug S-L-O-W-L-Y so most of the drug remains in the nose and doesn't go into the throat/mouth.

Implications: I think the correct way to say it is, "You can eat your cake, and have it too", but no one knows what I'm talking about. 

This study looked at what happens when you add a nasal steroid (ciclesonide) to someone who is already on Advair 500/50.  Please note that one of the authors has a slight, but critical, miscalculation.  He wrote that a patient on Advair 500/50 would be just under the critical level of fluticasone where we would worry about adrenal suppression since they only receive 500 mcg/day.  However, the article states that the patients were on Advair 500/50 twice daily = 1000 mcg of fluticasone per day.  That's well above the critical level of 800 mcg/day where fluticasone has been shown to cause adrenal suppression.  Here's the quote from the article: 

"The inhaled corticosteroid fluticasone propionate, at a dose of 500 mcg, combined with salmeterol at a dose of 50 mcg, was taken in the conventional manner of twice daily."

Analysis: This is an important study because lots of patients with allergies have asthma, and lots of patients with asthma have allergies; thus, it's not surprising that lots of patients will be on two different steroids per day.  The critical level is 800 mcg GlaxoSmithKline's fluticasone from all sources/day.  But for Astra/Zeneca's drug, budesonide (Pulmicort for asthma, Rhinocort for allergic rhinitis), that critical level is 600 mcg/day.  Meanwhile, for beclomethasone it's higher than 1000 mcg/day.  Each steroid is different.

Now, this study looked at Omnaris, ciclesonide for the nose.  I don't see this drug as being nearly as important as Alvesco, ciclesonide for the lungs.  The reason is that nasal steroids are effective at lower doses than asthma steroids.  For example, look at Flonase vs. Advair.  Flonase has about 50 mcg fluticasone per puff.  2 puffs in each nostril once a day = about 200 mcg fluticasone/day.  The average dose of Advair contains 250 mcg fluticasone per puff.  Twice daily use = 500 mcg fluticasone/day.  Still, this study is clever in that it points out how a little nose spray can indeed be the straw that breaks the camel's back. 

Omnaris the nose spray will use just a fraction of the ciclesonide dose that Alvesco the asthma inhaler will use; thus, reduced steroid side effects are much more important when treating asthma than when treating allergic rhinitis.

Lastly, think of what ciclesonide might do to Genentech & Novartis' Xolair, which some see as already on the ropes:  One reason we put patients on Xolair is concern about steroid side effects.  If Moderate Persistent patients with asthma on Alvesco (ciclesonide for asthma) don't get steroid side effects, they may be less likely to end up on Xolair.

Implications: Zileuton is much more than just Singulair taken 4 times a day. Its a much better leukotriene antagonist. Its benefit is comparable to inhaled steroids, and, alone, it can improve a patients pulmonary function test results for the volume of air blown out in the first second (FEV1). Singulair and Accolate have never been shown to improve a patient's FEV1

Four times a day dosing is pretty much a non-starter, though. I have a few patients on it, but it's a tough sell. Mostly for patients who need a stronger maintenance asthma drug than Singulair, but who refuse to take inhaled steroids for some reason.

Besides that four times a day dosing, there's the need to monitor liver function tests. That's not only a pain, but it's expensive. Except that it's not expensive at all. If you go to the lab for liver function tests with no insurance, it costs you $100. For the same test, Medicare or private insurances pay less than $10.

Analysis: Now Critical Therapeutics says they can give us a Zileuton for twice a day dosing instead of four times a day. That's great.

All you need to do now is contract with Labcorp or Quest for a whole bunch of liver function tests, and pay for them yourself. Bought wholesale, they will be dirt cheap, and patients will not mind getting the blood drawn as much if the drug company is paying the bill. The retail price on Zyflo is $262 for 120 pills, a one month supply, at www.drugstore.com . It's not whether Critical Therapeutics can afford to do this.

It's whether they can afford not to do this and just let Zyflo languish with its extremely poor sales.

Implications: This article points out that any device which holds the asthma medicine so that you can co-ordinate the puffing with the inhaling allows you to increase the percentage of the medicine that gets into your lungs.  As another reviewer correctly points out, this is very, very important in inhalers that use chlor-fluorocarbons (CFC's) as their propellant.  CFC inhalers shoot the medicine out at 70 miles per hour.  After it travels 2-3 inches, it's still moving fast when it reaches the back of your throat; there, it has to make a sharp turn to get down into your lungs.  It ain't easy making a sharp turn at 60 mph, and most of the medicine lands on your throat, not making it down to your lungs.        

Analysis: HFA Inhalers
New HFA inhalers have two advantages:  1) they don't contain CFC's, so they hurt the ozone, and; 2) they come out of the device at about 40 miles per hour instead of 70 mph in a CFC inhaler.

Still, 40 mph, which is still moving 30-35 mph after it travels 2-3 inches, is still a difficult speed to make a 90 degree turn to go down into the lungs.  So, the Mothers of Asthmatics (www.aanma.org) and many physicians recommend that kids and some adults use a spacer with HFA devices as well as with CFC devices.  Aerochambers are not cheap ($20-$30), though.  We have jerry-rigged spacers out of used toilet paper rolls, but the volume is really too low to allow significantly improved lung deposition of the inhaler.  This study looked at a low cost plastic bottle, maybe a 2 liter soda bottle, that can be modified into a spacer.  Sounds good to me.  And the price is right!

Implications: BACKGROUND
 
Xolair is the first Biotech drug for allergic asthma.  It works by blocking the effect of IgE, the allergic antibody (an antibody is an infection-fighting protein that your body produces to fight foreign invaders.  An allergic response to dust mites or pollen happens because your immune system mistakes that harmless substance for a dangerous germ and mounts a defensive response)

Xolair has been very helpful in some patients with severe asthma, especially in terms of increasing Quality of Life.  We haven't been able to put someone on Xolair and stop their Advair totally, but we can usually drop them from Advair 500 to Advair 250.  But I have lots of stories of patients who are now able to enjoy their garden, or go for a ride on their motorcycle.  And who barely notice their asthma symptoms unless they catch a cold or get a big exposure to whatever they're allergic to.

Analysis: COST AND CONTEXT
The current problem with Xolair is that it's expensive--about $12,000 - $30,000 per year, with most of it covered by insurance for most patients. But most doctors realize that somebody is paying the bill for that Xolair, and prudently reserve it for patients who still have symptoms despite pretty aggressive treatment. The other problem is that it's a shot, and many patients don't like shots. We have been letting some Xolair patients take their Xolair at home. I'm not sure if we will continue that.

We have known since the beginning that since Xolair is a protein, one can be allergic to that protein. Anaphylaxis (coined in 1902 from Greek "without protection"---think prophylaxis = with protection) is a severe allergic reaction that can be life threatening. The anaphylaxis rate published for Xolair is 1 out of 1000. What we thought till recently was that if you tolerate the first couple of Xolair injections, then you were not at risk for anaphylaxis.

RECENT CHANGES TO PRODUCT INSERT
Now it appears as if the risk of anaphylaxis does not go away if you tolerate Xolair for several shots--each dose has a risk of anaphylaxis. And it's not like regular allergy shots where the anaphylaxis occurs within 20-30 minutes of the injection. This report says the anaphylaxis can occur as late as 24 hours after the injection, or later.

RECOMMENDATIONS
I will be calling all of my Xolair patients so that they learn this from us and not from CNN. It does not mean that they should stop taking their Xolair.

To me, the bottom line is that each Xolair patient, like each allergy shot patient, should own an injectable epinephrine syringe (epinephrine = adrenaline). The two available are EpiPen and Twinject. EpiPen has a longer track record, but Twinject (Verus Pharmaceuticals) has a second dose of adrenaline inside the syringe, if the anaphylaxis does not resolve with one dose. Not all of my Xolair patients own an EpiPen or Twinject, but we will get them one or stop prescribing them Xolair.  Twinject is promoted heavily and has a $20 rebate on its web site and gives allergists cards that pay the first $50 of a patient's co-pay.  So adding a Twinject prescription to my Xolair patients who don't currently have it will not be a big out-of-pocket expense.

Will this reduce Xolair prescriptions? Probably. Most doctors thought the risk of anaphylaxis was a non-issue if it didn't happen early in the treatment course. Practice Parameters don't recommend that all allergy shot patients own and carry an EpiPen/Twinject when they receive their allergy shots, and certainly don't require it for Xolair. Maybe those recommendations will change. We already require it for our allergy shot patients, and will now require it for our Xolair patients.

To me, though, the risk of the anaphylaxis ( 1 out of 1000) is pretty low. Especially considering that most of my Xolair patients have Severe Persistent Asthma, (though the drug has FDA indications for Moderate - to - Severe Persistent Asthma.)  And the company really has been pushing for its use in Moderate Severe Asthma the past year or two. 

Bottom line--other than expense and the fact that its a shot, this is another reason for doctors not to recommend Xolair for patients with Moderate Persistent Asthma, but it shouldn't change recommendations for patients with Severe Persistent Asthma.  Since each Xolair patient will now own a Twinject or EpiPen, my own clinic's use will not change (except requiring that Twinject/EpiPen).