DO NOT USE! Asthma Drug Montelukast (SINGULAIR) For The Treatment Of Hay Fever

The Food and Drug Administration (FDA), on January 23, 2003, approved the asthma drug montelukast (SINGULAIR) for the relief of symptoms of seasonal allergic rhinitis (hay fever) in adults and children two years of age and older. Montelukast is a member of a family of drugs known as leukotriene inhibitors.

Montelukast is marketed by Merck & Company of West Point, PAand was originally approved for asthma in February 1998.

We already listed montelukast as a Do Not Use drug for asthma in the Companion to the 1999 edition of Worst Pills, Best Pills for two primary reasons.

First, the National Institutes of Health’s 1997 Guidelines for the Diagnosis and Management of Asthma said of the leukotriene inhibitors that “further clinical experience and study are needed to establish their roles in therapy.” At this time, the role of the leukotriene inhibitors in the management of asthma is still far from established.

Second, the leukotriene inhibitors are promoted as useful in helping patients reduce their dosages of steroid drugs, for example triamcinolone (AZMACORT). The Cochrane Database of Systematic Reviews published in 2002 found, in comparing leukotriene inhibitors to placebo in people also using steroids, that the dosage of inhaled steroids can be safely reduced without requiring the use of leukotriene inhibitors. Furthermore, the dose of leukotriene inhibitors required to achieve a significant reduction in steroid dosage is several times the currently approved maximum dosage.

In a triumph of advertising over science, despite these serious questions about its effectiveness, almost 13.5 million prescriptions were dispensed for montelukast in U.S.pharmacies in 2002 at a cost of almost $1.2 billion.

The recent approval of montelukast for seasonal allergic rhinitis was based on five clinical trials. All of the trials were similar in design. There was a total of 5,029 patients involved, of whom 1,799 were treated with montelukast. Patients in the trials were 15 to 82 years of age with a history of seasonal allergic rhinitis, a positive skin test to at least one allergen, and active symptoms of seasonal allergic rhinitis.

The effectiveness of montelukast in the five trials was assessed using the average change from the beginning of the study in daytime nasal symptoms score. This score is the average of individual scores of nasal congestion, rhinorrhea (runny nose), nasal itching, and sneezing as assessed by patients in the trial on a 0 - 3 point scale.

Four of the five trials found montelukast superior to a placebo (an inactive “dummy” drug). In the fifth trial, montelukast was compared to an active antihistamine, loratadine (CLARITIN). In this trial, the score for loratadine was superior to that of montelukast.

The Medical Letter On Drugs and Therapeutics, a highly respected, independent source of drug information written for health professionals, reviewed montelukast for hay fever in their March 17, 2003 issue, and concluded:

Montelukast (Singulair) might be as effective as an oral antihistamine for treatment of seasonal allergic rhinitis (more data are needed), but it is less effective than an intranasal corticosteroid, and more expensive than either.

We agree. Intranasal corticosteroids, or steroids, are also effective for hay fever. The Medical Letter was referring to studies showing that fluticasone (FLONASE) was better than either montelukast or loratadine for hay fever. Some other intranasal steroids on the market are beclomethasone (BECONASE AQ) and budesonide (RHINOCORT AQUA).

Overall, montelukast is an unremarkable treatment for hay fever, as is loratadine or its close chemical relative desloratadine (CLARINEX), for that matter. We wrote about desloratadine in the March 2002 Worst Pills, Best Pills News.

Our recommendation, as it has been for years, for the initial treatment of hay fever remains generic chlorpheniramine on the basis of both effectiveness and cost. The non-prescription antihistamines such as generic chlorpheniramine (brand name CHLORTRIMETON) are effective, perhaps equally or more so, than prescription antihistamines. The drowsiness that may be experienced by some people using generic chlorpheniramine can be avoided in many people by starting with a low dose and slowly working up to a dose that relieves symptoms without sedation.

Cost is always an important consideration, particularly when the effectiveness of a drug such as montelukast is only marginal. The table on page 82 lists the retail prices of a month’s supply of some of the drugs mentioned in this article for comparison. The prices were obtained from a Washington, DCchain pharmacy.

In summary, there are two reasons why we have listed montelukast as a Do Not Use drug for the treatment of hay fever symptoms. First, the drug has not been shown to be more effective than the oral antihistamine loratadine, at almost eight times loratadine’s cost. Second, the price discrepancy is even more outrageous when the comparison is with generic chlorpheniramine, which is as effective as prescription products like SINGULAIR and CLARINEX.

What You Can Do

You should not use montelukast for the treatment of hay fever symptoms because of its meager effectiveness and exorbitant cost.