FDA gives OK to drugs for seizures, allergies

August 26, 2009

In the last week, FDA has approved two pediatric-related drugs - one (vigabatrin) treats infantile spasms and the other (levocetirizine dihydrochloride) targets symptoms of indoor and outdoor allergies and chronic hives in young children.

In the last week, FDA has approved two pediatric-related drugs - one (vigabatrin) treats infantile spasms and the other (levocetirizine dihydrochloride) targets symptoms of indoor and outdoor allergies and chronic hives in young children.

In the case of the spasm-related drug (Sabril), a first such approval for treatment of infantile spasms, it marks the closure of a 15-year massive research undertaking of the drug's mechanisms by W. Donald Shields, MD, of the University of California, Los Angeles' School of Medicine.

A notable adverse effect of the drug includes loss of peripheral vision, which has affected up to 30% of users of the drug. However, Shields says the benefits outweigh this significant adverse event. "If you lose peripheral vision but are developmentally normal, it is probably worth it," he said in a statement.

Part of the FDA's approval of the seizure-related drug requires physicians who prescribe vigabatrin to conduct a baseline test of visual acuity prior to start-up of the drug, and then every three months following.

For infants, the drug is normally taken for 6 to 9 months. Dosage is often reduced at this point to see if symptoms re-emerge. If so, the dosage is increased to previous levels.

Regarding approval of the once-daily prescription antihistamine for allergies (Xyzal), it is approved for children age 6 months and older for treatment of symptoms related to perennial allergic rhinitis and chronic idiopathic urticaria. The drug is also approved for symptoms of seasonal allergic rhinitis in children age 2 and older.

Previously the allergy-targeting drug, available in tablet and liquid forms, was approved for children age 6 and older for the aforementioned symptoms.