- The Washington Times - Friday, May 11, 2001

The Food and Drug Administration's review today of an effort to make popular allergy prescription drugs available over the counter is alarming doctors and health advocates, who say too many people are taking generic allergy medications instead of going to the doctor for their ailments.
Tree-pollen allergies, which are particularly high this spring, cause symptoms like wheezing, fatigue and trouble breathing because of tightness in the chest and congestion. So when sufferers get red and itchy eyes, another symptom, they rush to their pharmacy for sinus or allergy drugs.
Yet those drugs sometimes only complicate the problem. Asthma, for instance, shares many of those symptoms, and over-the-counter allergy medications can be harmful because they suppress coughing something asthmatics should not do.
"I am completely opposed to moving the non-sedative antihistamines to over the counter," said Talal M. Nsouli, an associate clinical professor of Pediatrics and Allergy/Immunology at the Georgetown University School of Medicine. A private physician, he also served as personal allergist to President Bill Clinton.
"It will promote self-diagnosing and self-prescribing of medications, and this will result in only partial relief."
The three drugs under FDA scrutiny are Claritin, Allegra and Zyrtec, which with insurance coverage cost consumers $1 to $3 per pill.
Aside from worrying that these remedies would offer patients even more drugs to take incorrectly, many physicians say making the antihistamines over the counter would make them too expensive because insurers won't cover them.
"The average consumer is going to have to start paying for it out of his own pocket," said Dr. John S. Irons of the Allergy and Asthma Clinic of North Bethesda. "I think that's a real concern."
Pediatricians and allergists also are worried about the drugs' safety. The three medications have not been on the market long enough to determine their safety, especially for children, because testing has focused on adults and no dose has been set for children.
"There is some concern when you release products like this without a lot of explanation … it's an unfair judgment for parents to have to make," said Dr. Gloria Wilder Brathwaite, medical director of the Children's Health Project of D.C., a nonprofit medical center that cares for poor and uninsured children.
"The other challenge is for families who are impoverished and can't afford these products. Health insurance will no longer cover them. So then these products become out of reach for them and their children, and some have become very dependent" on Allegra, Claritin and Zyrtec.
The three drugs had combined sales of $4.7 billion last year, according to IMS Health Inc., a Pennsylvania health research company.
Taking those medications over the counter "might do more harm than good," said Valerie Carregal, an allergist and clinical immunologist who practices in Foggy Bottom. "A lot more thought goes into the diagnosis and treatment" when patients see doctors rather than when they diagnose themselves.
"I would hate for someone to take allergy medication for something else."
Doctors estimate that 20 percent of Americans have allergies, which result from matter like pollen, mold, foods or animal dander.
Although patients can buy antihistamines over the counter, those drugs come with side effects like drowsiness.
Since Claritin, Allegra and Zyrtec are non-drowsy, they have become doctors' favorite prescription drugs for patients with allergies and asthma.
Asthma is a respiratory illness that affects more than 17 million Americans. If untreated, or poorly treated, it can be deadly.
The FDA is holding a hearing today to review a petition by the nation's fourth-largest health insurer, WellPoint Health Networks, to sell Allegra, Claritin and Zyrtec over the counter.
WellPoint says if the drugs are as safe as their makers claim, they should not require prescriptions. But the drug makers, Schering-Plough Corp. (Claritin), Aventis SA (Allegra) and Pfizer Inc. (Zyrtec) say they need more time to collect reports from doctors who administer the medicines to ensure their safety.


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