For decades, allergy sufferers in Europe and much of South America have been able to control their allergies with daily under-the-tongue drops instead of shots.
And although the prescription drops are not approved by the Food and Drug Administration, their use is spreading across the U.S. too.
Like shots, the active ingredients in the drops are customized to the patients' allergies and use the same allergy antigens. Because the antigens in the shots are FDA approved, it is legal for doctors to prescribe the medication in a novel way. In this practice, known as off-label prescribing, a doctor uses an approved drug in a way that is not specifically listed in the FDA package insert. Botox and blood pressure medications prescribed for migraine headaches are common examples of off-label use.
Allergy drops are not for people who just sneeze for two weeks when the trees bud each spring. They are for people whose immune systems overreact to a variety of environmental offenders, mistaking harmless dust, pollen or other substances for threatening bacteria and going into overdrive to repel them.
Allergy drops work in the same way that shots do. The idea is to inoculate people with small amounts of the substances they are allergic to so that their bodies gradually develop immunity. Because such small amounts of the allergens are introduced with each shot or drop, it can take three to five years to reach a point at which a patient allergic to pollen, for example, will not sneeze in the spring.
Instead of going to a doctor's office for weekly shots, patients can take allergy drops at home. Patients place one or two drops under the tongue first thing in the morning and before going to bed at night.
There is no taste, and the only reported side effect can be some itching under the tongue for the first several weeks of treatment.
The drops cost about $12 a week, with most patients buying a three-month supply. They are not covered by most health insurance plans.
The drops have not been sufficiently studied in the United States, he says. In addition, there are no proven dose recommendations, and there is no way for doctors to bill for prescribing them, because they are not FDA-approved.
Excerpts taken from the LA Times 5/15
Bonnie - while I am not a proponent of off-label prescriptions, this development in the allergy field is promising. Maybe through more exposure it will achieve FDA-approval.
Thursday, May 18, 2006
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment