Nonprescription topical ivermectin approved for head lice

The U.S. Food and Drug Administration (FDA) has approved ivermectin 0.5% (Sklice, Arbor Pharmaceuticals) for the over-the-counter treatment of head lice. The drug was initially approved by the FDA in February 2012 for prescription use in patients 6 months and older.

Ivermectin 0.5% is a topical lotion for external use only and should only be used on dry hair or the scalp according to label instructions. The product is not approved for any other use.

According to the FDA, an estimated six to 12 million head lice cases occur in pediatric patients 3 to 11 years. Lice most commonly affect children in preschool, elementary school and members of a household where children have lice.

The decision to shift products to nonprescription is normally made by the manufacturer. The company must then prove the drug is safe and effective when used as directed in the proposed labeling in order for the switch to nonprescription to be made.

“The Rx-to-OTC switch process aims to promote public health by increasing consumer access to drugs that would otherwise only be available by prescription,” says Theresa Michele, M.D., acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research. “Today’s approval expands access to another effective topical treatment for the thousands of people with head lice.”

Ivermectin 0.5% from Arbor Pharmaceuticals will no longer be available via a prescription. Consumers are asked to read and follow the Drug Facts label for the nonprescription drug, as well as consult their healthcare professional according to a press release from the FDA.

Reference:

FDA Approves Lotion for Nonprescription Use to Treat Head Lice [News Release] October 27, 2020; White Oak, MD. https://www.fda.gov/news-events/press-announcements/fda-approves-lotion-nonprescription-use-treat-head-lice?utm_medium=email&utm_source=govdelivery. Accessed November 18, 2020