Drug Approvals for Rare Dermatologic Diseases
On July 19, 2019, apremilast, a phosphodiesterase 4 inhibitor, became the first medication approved by the FDA for the treatment of adults with oral ulcers due to Behçet disease, a rare multisystem inflammatory disease.18 The FDA approval was based on a double-blind, randomized, placebo-controlled trial in which 53% (55/104) of patients receiving apremilast monotherapy were ulcer free at week 12 compared to 22% (23/103) receiving placebo (P<.0001)(ClinicalTrials.gov Identifier NCT02307513).19
On October 8, 2019, afamelanotide was approved by the FDA to increase pain-free light exposure in adults with erythropoietic protoporphyria, a rare metabolic disorder associated with photosensitivity.20 A melanocortin receptor agonist, afamelanotide is believed to confer photoprotection by increasing the production of eumelanin in the epidermis. The FDA approval was based on 2 randomized, double-blind, placebo-controlled trials, both of which found that patients given afamelanotide spent significantly more time in direct sunlight without pain compared to patients in the placebo group (P=.005 and P=.04).21
Recalls of Popular Skin Products
On July 5, 2019, Neutrogena recalled its cult-favorite Light Therapy Acne Mask. The recall was driven by rare reports of transient visual side effects due to insufficient eye protection from the mask’s light-emitting diodes.22,23 Reported in association with 0.02% of masks sold at the time of the recall, these side effects included eye pain, irritation, tearing, blurry vision, seeing spots, and changes in color vision.24 In addition, a risk for potentially irreversible eye injury from the mask was cited in people taking photosensitizing medications, such as doxycycline, and people with certain underlying eye conditions, such as retinitis pigmentosa and ocular albinism.22,24,25
Following decades of asbestos-related controversy, 1 lot of the iconic Johnson’s Baby Powder was recalled for the first time on October 18, 2019, after the FDA found subtrace levels of asbestos in 1 of the lot’s bottles.26 After the recall, Johnson & Johnson reported that 2 third-party laboratories did not ultimately find asbestos when they tested the bottle of interest as well as other bottles from the recalled lot. Three of 5 samples prepared in 1 room by the third-party laboratories initially did test positive for asbestos, but this result was attributed to the room’s air conditioner, which was found to be contaminated with asbestos. When the same samples were prepared in another room, no asbestos was detected.27 The FDA maintained there was “no indication of cross-contamination” when they originally tested the implicated bottle.28