The tiny parasitic insects known as head lice can infest the head and neck area and attach their eggs to the base of the hair shaft. Head lice do not cause disease, but they can itch and irritate the scalp. And excessive scratching can cause bacterial infection. But a number of products are available to treat head lice, including a new drug approved in April 2009 by the Food and Drug Administration (FDA).
An estimated 6 to 12 million cases of head lice infestation occur each year in the United States in children 3 to 11 years of age, according to the Centers for Disease Control and Prevention. Head lice are most common among preschool children attending child care, elementary school children, and household members of children who have lice.
The Food and Drug Administration (FDA) is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market. FDA first alerted the public to the theft in June 2009.
Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use. The agency has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial...
Head lice are spread mainly by direct head-to-head contact with a person who already has head lice. Lice don’t fly or jump; they move by crawling. But because children play so closely together and often in large groups, lice can easily travel from child to child.
Head lice are blood-sucking insects about the size of a sesame seed and tan to grayish-white in color. They attach themselves to the skin on the head and lay eggs (nits) in the hair.
“Getting lice does not mean you are dirty—it only means that you’ve been around others with head lice,” says Susan Walker, M.D., director of FDA’s Division of Dermatology and Dental Products.
You can check for head lice or nits by parting the hair in several spots. Use a magnifying glass and a bright light to help spot them. Lice can move fast so it may be easier to spot the nits. Nits can look like dandruff, but you can identify them by picking up a strand of hair close to the scalp and pulling your fingernail across the area where you suspect a nit. Dandruff will come off easily, but nits will stay firmly attached to the hair.
FDA-approved treatments for head lice include both over-the-counter and prescription drugs in the form of shampoos, creams, and lotions. Many head lice products are not for use in children under the age of two, so read the label carefully before using a product to make sure it is safe to use on your child.
On April 9, 2009, FDA approved a new prescription medication for the treatment of head lice. Ulesfia (benzyl alcohol) Lotion, 5%, is approved for use in children 6 months of age and older. This new drug is the first FDA-approved head lice product with benzyl alcohol as the active ingredient.
The safety and effectiveness of Ulesfia Lotion, 5%, were shown in two studies of more than 600 people with active head lice infestation. The study participants received two, 10-minute treatments with either Ulesfia Lotion or a topical inactive substance (placebo), one week apart. More than 75 percent of the participants who received Ulesfia Lotion were lice-free 14 days after the final treatment, compared to 26 percent who received the placebo. The lotion kills lice but not nits, so the second treatment is needed to kill lice that have hatched since the first treatment.