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.
Founder/CEO Eat, Learn, Live (ELL)