With an eye on the food allergy community as a unique group of consumers since 2008, we're on a quest to find and share ways to continue enjoying the good things in life.


02 March 2009

ELL Issues Alert on Zyrtec


March 2, 2009

Eat, Learn, Live (ELL) is issuing an immediate alert to all food allergic consumers and caregivers of those afflicted with food allergies.

ELL was notified of an allergic reaction that was suffered by an ELL member who experienced hives and difficulty in breathing following the ingestion of ZYRTEC 10 mg adult tablets. As was recently recommended by ELL, the individual contacted both ZYRTEC directly as well as the local FDA office to file a complaint. An allergic incident report was also submitted to ELL (www.ellfoundation.org). ELL also contacted ZYRTEC regarding the incident and lack of cautionary warning statements indicating the presence of milk protein.

ZYRTEC (cetirizine HCI), an over the counter antihistamine for adults and children that helps relieve upper respiratory symptoms caused by allergy triggers such as dust, mold, and pet dander, tree pollen, weeds and grasses, has recently introduced several new over-the-counter products including adult tablets (10mg), ZYRTEK-D tablets and children’s chewables (5mg & 10mg) that contain lactose monohydrate (milk protein). Lactose monohydrate is listed as an inactive ingredient in each of these four products, but the package does not include a warning statement to consumers to indicate the inclusion of a milk protein. Lactose monohydrate is defined as a natural disaccharide, obtained from milk, which consists of one glucose and one galactose moiety. Please note, the liquid form of ZYRTEC does not contain lactose monohydrate.

ELL recognizes this potential danger to allergic individuals who may have been previously prescribed a similar ZYRTEC product prior to its release as an over-the-counter product.

To-date, ZYRTEC has taken no action in response to the consumer having experienced an allergic reaction from the ZYRTEC tablet product.

ELL has requested a voluntary recall of the ZYRTEC products listed above for a reformulation of the product ingredients or a redesign of its packaging to include a clearly marked warning statement for the inclusion of the milk protein. ELL strongly recommends the company clear its retailer’s shelves to protect other consumers from potential allergic reactions to these products until such modifications are made.

Since the FDA does not require pharmaceutical companies to include common language terminology for the top 8 allergen ingredients, this is another call for amendments and enforcements of the existing allergen ingredient labeling laws. The Food Allergy Labeling & Consumer Protection Act (FALCPA) of 2004 dictates that food manufacturers use common terminology for the top 8 allergen ingredients.

Other medications to also be aware of as listed by The Allergy/Asthma Information Association (AAIA) as containing lactose (milk):
· 4 mg granules & 10 mg tablets (not in the 4 mg or 5 mg tablets)
· Reactine, Aerius, Claritin tablets (not liquid form).
· Benadryl 50 mg pink/white capsule (not caplet, chewable tablets or liquid form)
· Prednisone tablets

ELL encourages any other consumers having experienced an allergic reaction from any of the ZYRTEC products containing lactose monohydrate to contact ELL to file an allergic incident report at www.ellfoundation.org.

Best regards,
Kathleen Silverman
Founder/CEO Eat, Learn, Live (ELL)
ksilverman@ellfoundation.org
www.ellfoundation.org
630-262-1154

8 comments:

Alexis and Ryan's Mom - Michele said...

Check with your doctor - tell them to actually read the "RED" Book. Most medications in pill form us lactose as a binder!!! Those severly allergic to dairy react to lactose.

Jennifer B said...

Thanks for this info!

Food Allergy Assistant said...

...As do many inhaled medications...

Advair and the medication being used to treat flu this season- Relenza- also contain dairy.

Vivian said...

Thanks for this!

Brenda said...

OMG, My son just had a reaction to Claritin pills due to the lactose.

Glad to know about other meds...

Anonymous said...

I can't even begin to explain how stressful this is. I just found out that Pulmicort and Benadryl also contain dairy as well as flovent meanwhile my son who has severe allergies to dairy,eggs,peanuts,etc had been prescribed these meds by the hospital and physicians.I have been devasted for days now and researching every single thing I can to keep my son safe. This is truly a nightmare I wish the FDAwould make more of an effort to educate our so called healthcare providers so that we don't have to learn the hard way!!!

Lena said...

Interestingly the alert states that the liquid form of Zyrtec doesn't contain the offender, however, my son (who's allergic to casein) had a very strong reaction to the liquid form of it. Perhaps a coincidence but somehow I think not... When I contacted his doctor she admitted that she wasn't aware about this issue with Zyrtec but suggested that we switch to Allegra (my son's is 3 years old). Has anybody head anything bad about Allegra?

Thank you, Lena

isaac32767 said...

"Lactose monohydrate" is not "milk protein". You're probably thinking of casein, which is indeed a potentially lethal allergen.

I avoid lactose because (like many people) I lack the digestive enzyme needed to avoid intestinal wackiness. I am not allergic to casein -- I actually look for it as an ingredient in soy and rice cheese substitute, because I find the brands that don't use it inedible.

I suppose any medication that contains lactose might also contain traces of casein. But to simply conflate two completely different chemicals in this way is not something a responsible health writer should do.

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