Parabens in my toddler's Allegra - what to do?

Zizzle · Post by **Zizzle** » Mon Apr 04, 2011 11:58 pm

My almost 4 yr old daughter has bad tree pollen allergies. I used to give her Zyrtec but she developed insomnia and aggressive behavior this year so we switched her to Allegra. She is doing much better with sleep and behavior, but I'm really concerned about the ingredients in the oral suspension. My husband's family (the source of her allergies) has taken Allegra for years, so we figured we'd take what works for everyone in the related gene pool. Allegra chewables are only for ages 6+. The liquid must be taken twice a day - so 2 teaspoons a day.

We went through a 4 oz bottle in 2 weeks, which means she's ingesting 2 ounces of parabens and propylene glycol every week! I'm a health conscious mom and I buy paraben-free skin-care products. I hate for my daughter to be ingesting far greater quantities of these endocrine inhibitors from a needed medication. This is the inactive ingredient list in order (notice butylparaben is listed first, which is especially concerning).

Inactive Ingredients
Butylparaben, edetate disodium, flavor, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucrose, titanium dioxide, xanthan gum, xylitol.

Should I consider changing medications? Try Claritin even if if may not work and set her back in the middle of tree pollen season?

Here's what the National Toxicology Program (2004) has to say about butylparaben:

Parabens are esters of 4-hydroxybenzoic acid that have recently been reported to have estrogenic activity in experimental cell systems and animal models. The toxicological database for the most commonly used parabens is quite extensive and generally indicates a low degree of systemic toxicity. Several recently published studies, however, have reported adverse effects of propylparaben and butylparaben on the male reproductive system in rodents. Butylparaben is included among the parabens widely used as antioxidants and preservatives in foods, pharmaceuticals, and cosmetics. It is regulated by the U.S. FDA as a synthetic flavoring and adjuvant. The FDA Center for Food Safety and Applied Nutrition estimated that people living in the United States consume an average of 37 ng butylparaben per day. Human exposure to butylparaben may occur via inhalation, eye or skin contact, or ingestion. Inhalation exposure causes irritation to the respiratory tract. Contact with the eyes or skin can cause irritation, redness, pain, and/or itchiness, but patch test results show that the sensitization potential of parabens is low. Ingested butylparaben is rapidly absorbed from the gastrointestinal (GI) tract, metabolized, and excreted in the urine. Large doses, however, may cause irritation to the GI tract. In mice, rats, rabbits, and dogs, butylparaben was reported to be practically nontoxic. Results from one chronic feeding study in mice showed that butylparaben caused a high incidence of amyloidosis, affecting the spleen, liver, kidney, and/or adrenal gland. It was cytotoxic in isolated rat hepatocytes and mitochondria and in other animal cells in vitro. Reproductive studies in mice and rats suggested that maternal exposure to butylparaben in the diet results in adverse effects on the reproductive system of F1 male offspring. Butylparaben was not mutagenic in several short-term bioassays (e.g., Ames test, Chinese hamster ovary cells, and comet assay) and was reported to be non-carcinogenic in rats and mice.

mbeezie · Post by **mbeezie** » Tue Apr 05, 2011 4:57 am

Zizzle,

Is liquid Claritin free of those things? If so it might be worth a try. I wonder if a compounding pharmacist could make up something free of all the additives?

Mary Beth

harma · Post by **harma** » Tue Apr 05, 2011 5:53 am

have you considered Xyzal? I have used zyrtec for years and switched about 5 years ago to Xyzal, works perfect for me. No side effect at all.

Polly · Post by **Polly** » Tue Apr 05, 2011 6:30 am

Hi Z,

I wonder why in the world they would need to use such toxic inactive ingredients.

Can you find a compounding pharmacy in your area that could make up a safe solution for her?

Hugs,

Polly

Zizzle · Post by **Zizzle** » Tue Apr 05, 2011 10:02 am

I've emailed the company and I posted a similar question to their Facebook page, so I hope to create a stir. I would consider breaking up the chewables if I could. Claritin does not contain parabens, but the first ingredient is aspartame, and the other ingredients are not the best either. I think Claritin chewables are an option for her age, and it's once a day dosing, so that might be the better choice. Bummer, we were so looking forward to Allegra.

I'm sure there are compounding pharmacies somewhere in DC. I'll look into it. Thanks!!

Post by **tex** » Tue Apr 05, 2011 11:24 am

For Xyzal, inactive ingredients are:

Sodium acetate trihydrate, glacial acetic acid, maltitol solution, glycerin, methylparaben, propylparaben, saccharin, flavoring (consisting of triacetin, natural & artificial flavors, dl-alpha-tocopherol), purified water.

Tex

Zizzle · Post by **Zizzle** » Tue Apr 05, 2011 11:33 am

OMG, can it get any worse?? I decided to look up another strange ingredient: Poloxamer_407 (aka: PEG/PPG-125/30 Copolymer or Poloxalene) "It is a non-ionic polyol surface-active agent used medically as a fecal softener and in cattle for prevention of bloat."

http://en.wikipedia.org/wiki/Poloxamer_407

Poloxamer 407 is a triblock copolymer consisting of a central hydrophobic block of polypropylene glycol flanked by two hydrophilic blocks of polyethylene glycol (PEG - something we are avoiding here, can't remember why)

It was reported in The Australian newspaper 18 November 2006 that this common ingredient in toothpaste and mouthwash can cause high cholesterol [1]. A team from the Centre for Ageing and the ANZAC Research Institute in Sydney found that when P407 was given to mice, it coated cells in the liver that control cholesterol levels, leading to a 10-fold increase in levels. The amounts given were not reported in the article.

In this study on rats, "Long-term administration of poloxalene given in semipurified diets resulted in changes in food intake, weight gain, fecal fat output, and serum cholesterol concentrations"

http://www.sciencedirect.com/science?_ob=ArticleURL&
In this study on rats, _udi=B6WFB-4C52FM1-6&_user=10&_coverDate=04%2F30%2F1984&_rdoc=1&_fmt=high&_orig=gateway&_origin=gateway&_sort=d&_docanchor=&view=c&_searchStrId=1706764921&_rerunOrigin=google&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=56a02aed9e460e95a167c4fadb33cfff&searchtype=a

Frankly, I can't find any human uses for this stuff except for toothpaste! Why is it in medicine for young kids!!

sarkin · Post by **sarkin** » Tue Apr 05, 2011 12:30 pm

Why indeed, Zizzle?

(And why is it in toothpaste???)

And getting back to the impending tree pollens - I was hoping that eliminating all suspect foods would lead me to have an easier time with the impending allergy season, but I fear I didn't get started in time. I am almost afraid to look at the ingredients in the herbal I've been using for allergies (nettles, but what else?)...

I hope you find a product or a compounding pharmacy before the trees kick into high gear,

Sara

Post by **tex** » Tue Apr 05, 2011 1:09 pm

Zizzle wrote:Frankly, I can't find any human uses for this stuff except for toothpaste! Why is it in medicine for young kids!!

Because the FDA allows it. The FDA publishes lists of allowable additives for certain types of products, and manufacturers scan those lists, looking for cheap options. If it's on that list, someone will probably use it, (if for no other reason, just to be different).

Sara,

I've been taking Metanx, (which is a prescription-only combination of megadoses of vitamins B-12, B-9, and B-6, especially formulated to treat peripheral neuropathy due to diabetes mellitus), for about a year and a half, now. (I take it to treat peripheral neuropathy which I believe was caused by gluten damage, since I'm not a diabetic). Last spring, my hay fever symptoms were much milder than they have been, previously, and this year, (so far, at least), they are virtually non-existant. I haven't taken an antihistamine in over a year, now, and previously, my symptoms were often so bad that I couldn't function without taking an antihistamine, (due to constantly watery eyes, sneezing, congestion, etc.).

Folic acid, (also known as vitamin B-9), is known to suppress hay fever symptoms, when taken in large amounts, and Metanx contains 19 times the RDA of folic acid, (if I recall correctly). I'm not suggesting that anyone take folic acid, though, to control hay fever symptoms, unless you take it in the combination found in Metanx. These B vitamins are interdependent, and need to be taken together, in order to keep things in balance. I didn't have any problem getting my GP to write a prescription for me, because I found out that he has been taking it for years, to maintain and improve cognizance, memory, etc. It took several months, before I noticed any benefits at all, but after taking it for 9 months, my reflexes had returned to normal in my knees and ankles, and I could once again feel a pin prick everywhere on my feet. Before I started taking it, my reflexes from my knees on down, were dead, (no response at all), and my feet had no feeling. Consequently, I had the same risk as some diabetics, of experiencing an undetected injury that might end up causing an infection, requiring amputation, simply because I never noticed the injury, due to loss of feeling. I'm nowhere near normal, but at least a little feeling has been restored, and the effect on my hay fever has been eye-opening, to say the least.

Tex

sarkin · Post by **sarkin** » Tue Apr 05, 2011 2:26 pm

Thanks, Tex - this is great to know. I've long been a fan of the Bs (and those three in particular), and will discuss this with my doctor, and gently up my intake before the trees bloom. In this case you're ahead of me seasonally as well as in knowledge & experience, and I'm again the lucky beneficiary.

About six months or so I noticed I had a little less feeling in one thumb than the other. It's gotten a little better (maybe going GF, or maybe my chiropractor, or maybe both or neither). It never occurred to me that it might be MC related.

It's truly wonderful that you've had some restored feeling, and therefore reduced risk from possible injury. And the effect on hay fever symptoms is another huge bonus.

Best,
Sara

Zizzle · Post by **Zizzle** » Wed Apr 06, 2011 8:39 am

I called the Sanofi-Aventis-Chattem, the maker of Allegra and they patched me through to a pharmacist. I realized that the Oral Desintegrating Tablet for kids (ODT) is the same dose (30 mg) as the suspension, so I asked why the ODT was not approved for children under 6. I asked if it was simply due to the studies/trials and who they were conducted on. She said probably. She also said younger children might not be willing to let the tablet dissolve on their tongue completely (My daughter will - it's orange cream flavor). She said I should call my pediatrician and ask if they are OK with it before we switch. I registered my concern with her about the parabens in the suspension and she said she would bring it to their quality group. I plan to sound the alarm about this in other mom-allergy circles too, since Allegra just hit store shelves.

Here are the ingredients for the dissolving tablet. It seems better (I think) despite the aspartame.

Other information
• each tablet contains: sodium 5 mg
• phenylketonurics: contains phenylalanine 5.3 mg per tablet

Inactive ingredients
aspartame, citric acid anhydrous, crospovidone, flavors, magnesium stearate, mannitol,
methacrylic acid copolymer, microcrystalline cellulose, povidone, sodium bicarbonate,
sodium starch glycolate.

Coach Polly · Post by **Coach Polly** » Wed Apr 06, 2011 10:19 pm

Don't overlook the regular "pill" version of these meds. My children are 6 and 8 and have been swallowing Zyrtec for 2 years now. When my son was 4 I put half a pill in his hand and said "swallow this" and he did. I made such a big deal out of it that my daughter had to try (she couldn't be outdone by her little brother!) They now request the pill form of every medicine they have to take. I'm not sure if the pills will have any better ingredient list but if they do, don't underestimate her ability to handle a pill.