FDA Issues Warning Regarding Zicam

June 17th, 2009

Loss of sense of smell has been a recognized complication of intranasal Zinc application.  Yesterday, the FDA finally came out with a warning regarding Zicam, a product which contains Zinc for intranasal application. I’ve reposted yesterday’s bulletin from the AAAAI to its members after the jump.

To me, this case illustrates a couple of important issues.  First, you don’t get pharmaceutical effects without the potential for adverse reactions.  Just because something is “natural” does not make it innately safer than compounds which are crated in a lab and extensively tested.  Second, the lack of oversight of the supplement industry is appalling.  As long as manufacturers call their product a dietary supplement and say “this product is not intended to diagnose, treat, or cure any disease” then they can say whatever they want without a shred of proof that their claims are true.  If their products really work, they should be required to show proof of effectiveness and safety, just like the pharmaceutical industry.

Dr. O

“This morning, The Food and Drug Administration (FDA) held a news conference warning physicians and consumers about Zicam Cold Remedy intranasal products, indicating “these products may pose a serious risk to consumers who use them.” Specifically, the FDA has received more than 130 reports of anosmia (loss of sense of smell, which in some cases can be long-lasting or permanent), associated with use of these products. Some individuals also report loss of sense of taste.

Included in the warning are:  Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs, and Zicam Cold Remedy Swabs, Kids Size.  All are administered by direct application to the nasal cavity, and as described in the labeling, are intended for use in “adults and children 3 years of age and older (with adult supervision).  These products are available without a prescription, and they contain zinc gluconate (identified as zincum gluconicum on their labels) as their active ingredient.

These OTC’s are marketed as homeopathic and therefore are not subject to FDA approval.  However, given the risk, the FDA has issued a warning letter to Matrixx Initiatives, Inc, makers of the products.  During the news teleconference, the FDA indicated they have asked Matrixx to work with the FDA in removal of the products from the market.”

Food Allergies in Adults

February 26th, 2009

Spring is almost here.  The pollen will soon be in the air.  People will begin sneezing and buying kleenex in bulk to deal with their runny noses.  One area we evaluate and treat that is not seasonal is food allergy.  Most people think of children when they think of food allergies.  Looking at the numbers they would be correct.  Between 6 and 8 percent of children in the U.S. suffer from food allergies compared to between 3 and 4 percent of the adult population.  Fortunately for children, many food allergies can be outgrown.  Peanut allergy in children is the most prevalent allergy that is not outgrown.  This is often not the case with adults.

I saw a gentleman yesterday in his early 50s.  He waited to make his appointment because he thought that only children had food allergyes.  He wanted to be evaluated because he thought he might be allergic to shrimp.  He had shrimp 2 weeks ago and within an hour he was covered in hives.  He was evaluated in the local emergency room and discharged without difficulty.  When I tested him yesterday in the office for shellfish allergy, he was grossly positive to shrimp, lobster, and crab. 

There are a few points that I want to highlight in regards to this patient.  When I asked him if he had ever had difficulty with shrimp or other fish/shellfish previously, he was not sure.  He did recall that whenever he helped his wife clean shrimp, his hands would itch.  They did not eat shellfish often so this was not a common occurrence.  Do I think this man in his 50s just developed an allergy to shellfish at this point in time.  No.  I think that he has had an allergy to shrimp for years.  That is based on the itching that he had when he came in contact with the shrimp.  He did not consume shellfish often so whatever symptoms may have been present were likely forgotten over time.  This man is fortunate.  The most prevalent food allergy which results in death in adults is shellfish.  Just because you have an upset stomach or hives with the first reaction does not mean that the next time you will not have a life-threatening condition called anaphylaxis. 

He was evaluated and treated at the local emergency room.  The great omission in this case is that he was discharged from the emergency room without a prescription for injectable epinephrine.  Epinephrine is the one treatment that significantly decreases the risk of death associated with severe allergic reactions.  Many people also use this for stinging insect allergies.  Emergency rooms failing to do this is not an uncommon problem and has been reviewed in many articles in the medical literature.  As mentioned previously, just because you have hives with one reaction does not mean you will not have a fatal reaction the next time. 

The patient was evaluated in my office yesterday and he was diagnosed with shellfish allergy.  I instructed him to avoid all shellfish since avoidance is the only definitive treatment for food allergy.  However, in case of an accidental exposure, he was prescribed injectable epinephrine.  We discussed when you would use this medication as well as demonstrated to the patient how to administer the medication.

If you have noticed problems after eating certain foods such as hives, upset stomach or abdominal pain, rash, swelling, itching, difficulty breathing, or a feeling of lightheadedness, you may have a food allergy.  The diagnosis is simple and the treatment may save your life.  Don’t think that because you are an adult that you may not have food allergies.

A Bit about Hives

February 20th, 2009

Hives can be a maddening problem.  At their mildest, they can simply be bothersome and at their worst can be dangerous.  Trying to uncover the cause of hives is a difficult and often fruitless task.

It is helpful to break hives down into acute and chronic hives.  Acute hives occur once and go away whereas chronic hives linger.  Allergists see far fewer cases of acute hives, because the cause is often obvious: I went to Red Lobster and had the shrimp platter.  My lip swelled immediately then it went away. Confirmatory testing is sometimes helpful, but most people simply avoid the obvious offenders.

Chronic hives often lack this sort of obvious history and, ironically, are much less likely to be allergic.  Having seen thousands of cases of chronic hives over the last decade, I have learned a few things here and there.  First, its not your soap/shampoo/detergent that’s causing hives.  These things cause contact dermatitis, but very rarely result in hives.  Second, the more foods you think may be causing hives, the less likely it is that you have a food allergy.  Having more than 2 food allergies as an adult is vanishingly rare. Allergic reactions to foods most often occur within 15-30 minutes after ingestion and almost always within 2 hours, so if you’re waking up in the middle of the night, then its probably not a food allergy.  Third, watch your supplements!  I’ve seen numerous cases where discontinuing certain supplements/natural remedies has brought about an immediate end to hives.  Finally, don’t suffer needlessly.  If simple antihistamines-I like cetirizine- aren’t working, your allergist has ample experience with multiple other medications to help control symptoms.  Allergists are also well versed in the myriad other rare causes for hives and can direct an appropriate work-up.

Nut so bad…….

December 29th, 2008

I’ll apologize straight away for the groan-inducing headline.  Nut allergy is a serious subject and as allergists, we must walk a fine line between imparting the potential seriousness of a reaction and scaring parents into a fear-induced paralysis.  A recent study published in the Journal of Allergy and Clinical Immunology, the main U.S. allergy journal, shows that through planning and education, rates of reactions can be lowered considerably.

The study followed 785 kids for an average of about 5 years.  All the kids had been seen in a specialty allergy clinic , had written avoidance information and written treatment plans, and had schools which had been educated on how to deal with nut reactions.  A few important statistics stood out to me.

First, only 5% of reactions during the study period occurred in schools.  This should be reassuring to parents who worry while their children are out of their control and also warns that the majority of accidental ingestions are due to the parents or children themselves.

The annual risk of reaction was about 3%, which is considerably lower than in previous studies.  Only 10% of study period reactions occurred in very young kids, <4 years, and 90% of those reactions were mild.

Recent dogma has been that subsequent peanut reactions may be more severe than the initial reaction, but this study found that 90% of reactions were of equal or less severity than the initial reaction.  Of those that worsened, only 1 was deemed severe.

All reactions deemed moderate or worse were due to ingestion.  Contact reactions were all mild.  There were no reports of reactions from inhalation.  This should help us further tailor our avoidance recommendations.

The final take home point here is that specialty care is important in cases of nut allergy.  Allergists see more cases of nut allergy than other doctors and are specially trained to handle them.  Our job is to take the time necessary to educate families on these issues.  If you have a child with nut allergy, seeing a allergist is important.

When should we introduce peanut into the diet?

December 11th, 2008

The prevalence of peanut allergy is on the rise in many Western countries, including the US and the UK.  This has led to the recommendation that parents delay introducing peanut into the diet.  As I touched on in one of my earlier posts, there really hasn’t been any evidence to support this recommendation.  Now, a new study out of Britain suggests this may be the wrong thing to do.

The study sent a detailed food questionnaire to thousands of Jewish families in the UK and Israel.  In this way the study authors automatically controlled for genetic and socioeconomic differences.  The rate of peanut allergy is almost tenfold lower in Israel, .17% vs. 1.8%.  The only difference the study authors found was that Israeli children ate peanut much earlier than their British counterparts.  Nearly 100% of Israeli kids had eaten peanut by age 12 months as compared to around 25% of the Brits.

This was a very well done study, but it is still only a population study.  Prospective controlled trial are needed now to sort out this issue.  If a simple recommendation could potentially lead to a 90% reduction in peanut allergy rate, it should be a top priority.

Dr. O

Allergy-Safe Cupcakes and Cookies

December 4th, 2008

Who doesn’t like a good cupcake?  For kids with food allergies, though, cupcakes can be a no-no.  Fortunately for Nashville parents, two businesswomen have opened Kateelayne carefree treats, a bakery offering allergen-free cupcakes and cookies.  They’re kosher and vegan,too.  Check them out.

Probiotics and eczema

October 9th, 2008

Probiotics are getting plenty of attention these days regarding their potential health benefits.  The general idea is that by introducing “good” bacteria to the gut you can somehow modify disease states.  In the medical community, the idea started to take hold with the advent of the “hygeine hypothesis”, a theory which held that childhood exposure to common infections could reduce allergic sensitization.  Researchers then noticed that children from Estonia, where there is a very low incidence of eczema, had higher levels of the “good” bacteria, lactobacillus, in their stool, than did children from Sweden, where there is a much higher incidence of eczema. (I’m just glad I didn’t have to do my fellowship in Estonia.)

In the years that followed, numerous trials have been done looking at the effect of probiotic supplementation on allergic disease, including this excellent study from New Zealand published in this month’s Journal of Allergy and Clinical Immunology.  The results have been mixed and are complicated by the fact that numerous probiotic bacteria species have been used and the timing of supplementation has varied greatly.  The take home message is this:

  • Not all probiotics are created equal.  Lactobacillus rhamnosus is the species most often found to be effective.
  • In high risk subjects- those with a strong family history- L rhamnosus reduced the relative risk of eczema by around 50%, from an absolute risk of 28% down to 14%.  Another way of putting it is that 8 kids would have to be treated to prevent one case of eczema.
  • Supplementation has worked best when done during pregnancy and breastfeeding by mom and for the first 2 years of the child’s life.
  • Despite the reduction in eczema, probiotic supplementation has consistently been shown to not reduce the incidence of either food or inhalant allergies.

Prevention of disease should always be the first goal of medicine. Based on this recent study and others, I think there is enough information to support probiotic supplementaion for the prevention of eczema in high risk individuals.

Dr. O