home
RSS
Allegra approved for OTC sales
January 26th, 2011
12:42 PM ET

Allegra approved for OTC sales

The nation's best-selling antihistamine, Allegra, was approved Tuesday  by the U.S .Food and Drug Administration for over-the-counter use in adults and children 2  and older.

The allergy medicine, made by the pharmaceutical company Sanofi-Aventis, will hit shelves March 4, just in time for the spring allergy season.

Allegra, also sold generically as fexofenadine, is used to treat allergy symptoms such as sneezing, runny nose, itchy, watery eyes and itchy nose and throat that result from indoor or outdoor allergens.  About 50 million Americans suffer from indoor and outdoor allergies in the United States, according to the Asthma and Allergy Foundation of America.

"The FDA approval of over-the-counter Allegra will provide patients with another choice of a non-sedating OTC antihistamine," Dr. Clifford W. Bassett, an allergy specialist at New York University told CNN via email. But he also recommends talking to your doctor about your symptoms. "It is not uncommon to see patients with a variety of nasal and sinus symptoms, but when tested, do not actually have allergies. They may have sinus problems, infection, deviated septum, etc. So it is very useful to have simple in-office allergy tests to confirm indeed you do have seasonal or indoor allergies, so you get the correct treatment for YOUR symptoms."

Drug, grocery, mass merchandiser and club stores will carry the product and individual retailers will control the pricing.

Allegra products available over the counter will include: Allegra 24-Hour and 12-Hour Tablets as well as Allegra-D 24-Hour and 12-Hour Allergy and Congestion Extended Release Tablets for adults and children ages 12 and older, Children's Allegra 12-hour tablets and the 12-Hour Orally Disintegrating Tablets for children ages 6 years and older and Allegra Liquid for children ages 2 years and older.


soundoff (8 Responses)
  1. informedpharmd

    That makes sense, allegra has ton's of interactions tough on the body and now won't be covered by insurance. Smooth move FDA. Buy buy copay hello cash pay

    January 30, 2011 at 16:52 | Report abuse | Reply
  2. informedpharmd

    Carcinogenesis: (CANCER) The carcinogenic potential of fexofenadine was assessed using terfenadine studies with adequate fexofenadine exposure (based on plasma AUC values). No evidence of carcinogenicity was observed when mice in an 18-month study and rats in a 24-month study were given daily oral doses of terfenadine up to 150 mg/kg; these doses resulted in approximately 3 and 5 times, respectively, the exposure from the daily oral MRHD of fexofenadine in adults (180 mg) and children (60 mg), respectively.1

    Mutagenesis: In in vitro (bacterial reverse mutation, chinese hamster ovary cell/hypoxanthine-guanine phosphoribosyl-transferase forward mutation, and rat lymphocyte chromosomal aberration assays) and in vivo (mouse bone marrow micronucleus assay) tests, fexofenadine revealed no evidence of mutagenicity.1

    Fertility impairment:
    In rat fertility studies, dose-related reductions in implants and increases in postimplantation losses were observed at an oral dose of terfenadine 150 mg/kg (which led to fexofenadine exposures that were approximately 3 times the exposure of the daily oral MRHD of fexofenadine 180 mg based on comparisons of AUCs).1

    In mice, fexofenadine produced no effect on male or female fertility at average oral doses up to 4,438 mg/kg (approximately 10 times the daily oral MRHD of fexofenadine 180 mg based on comparison of AUCs).1

    Children:
    The recommended dose in patients 6 to 11 years of age is based on cross-study comparison of the pharmacokinetics of fexofenadine in adults and children and on the safety profile of fexofenadine in adults and children at doses equal to or higher than the recommended doses.1

    The safety of fexofenadine tablets at a dosage of 30 mg twice daily has been demonstrated in 438 children 6 to 11 years of age in 2 placebo-controlled, 2-week, seasonal allergic rhinitis trials. The safety of fexofenadine for the treatment of chronic idiopathic urticaria in patients 6 to 11 years of age is based on cross-study comparison of the pharmacokinetics of fexofenadine in adults and children and on the safety profile of fexofenadine in both adults and children at dosages equal to or higher than the recommended dosage.1

    The efficacy of fexofenadine for the treatment of seasonal allergic rhinitis in children 6 to 11 years of age was demonstrated in 1 trial (N = 411) in which twice-daily dosages of fexofenadine 30 mg tablets significantly reduced total symptom scores compared with placebo, along with extrapolation of demonstrated efficacy in patients 12 years of age and older, and the pharmacokinetic comparisons in adults and children. The efficacy of fexofenadine 30 mg twice daily for the treatment of seasonal allergic rhinitis in children 2 to 5 years of age is based on the pharmacokinetic comparisons in adults and children and an extrapolation of the demonstrated efficacy of fexofenadine in adults with this condition and the likelihood that the disease course, pathophysiology, and the drug's effect are substantially similar in children to those in adults. The efficacy of fexofenadine for the treatment of chronic idiopathic urticaria in children 6 months to 11 years of age is based on an extrapolation of the demonstrated efficacy of fexofenadine in adults with this condition, and the likelihood that the disease course, pathophysiology, and the drug's effect are substantially similar in children to those of adults. Administration of a fexofenadine 15 mg dose to children 6 months to younger than 2 years of age and a 30 mg dose to children 2 to 11 years of age produced exposures comparable with those seen with a 60 mg dose administered to adults.1

    The safety and efficacy of fexofenadine in children younger than 6 months of age have not been established.1

    Elderly:
    Clinical studies of fexofenadine tablets and capsules did not include sufficient numbers of elderly subjects (65 years of age and older) to determine whether this population responds differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.1

    This drug is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, take care in dose selection; it may be useful to monitor renal function.1

    January 30, 2011 at 16:57 | Report abuse | Reply
  3. Ann

    informedpharmd – Huh? "tough on the body"? All that quote says is that Allegra is safe aside from potential concern for people with kidney problems. It is one of the safest drugs around, safer than OTC pain relievers, and pretty much entirely free of even minor side effects.

    February 4, 2011 at 16:43 | Report abuse | Reply
  4. Lora Harris

    Is it OK, to take prune juice with Allegra (OTC)? there are no Directions with our purchase...or on the Box....

    April 17, 2011 at 15:03 | Report abuse | Reply
  5. moedbet

    Thank you – this is awfully constructive !

    May 22, 2011 at 00:16 | Report abuse | Reply
  6. Occaxarnulfo

    must look at this coach authentic at my estore coach authentic handbags to your friends

    August 18, 2011 at 14:46 | Report abuse | Reply
  7. Tieks

    must look at this coach 2010 collection french coach , just clicks away coach fall 2010 with low price

    October 15, 2011 at 16:56 | Report abuse | Reply
  8. Dorthea Holmes

    Anthistamines are really necessary if you have perenial rhinitis and urticaria. ;

    My favorite web blog
    http://www.healthmedicinelab.com/chest-pain-in-women/

    October 31, 2012 at 04:51 | Report abuse | Reply

Post a comment


 

CNN welcomes a lively and courteous discussion as long as you follow the Rules of Conduct set forth in our Terms of Service. Comments are not pre-screened before they post. You agree that anything you post may be used, along with your name and profile picture, in accordance with our Privacy Policy and the license you have granted pursuant to our Terms of Service.

Advertisement
About this blog

Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.