Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Skin hyperpigmentation, Skin lesion, Thermal burn, Urticaria
Clinical narrative: To whom it may concern: The follow narrative describes an adverse reaction to Azstarys in our 13-year-old daughter. As you see in the details, we believe the reaction is to non-active ingredients, specifically the artificial dyes in the medication. We are concerned that the exposure to dyes in Azstarys have created a new hypersensitivity to these dyes, including via other sources. However, there were many potentially confounding factors, so we have attempted to be thorough in our description of events. Please fee free to contact us if you have any questions. Our daughter is diagnosed with Attention Deficit Hyperactivity Disorder-Combined Type. She has been taking stimulant medication since 2018. Short and long-acting stimulants, including Concerta, Focalin and Vyvanse cause significant side effects, including appetite suppression, sleep disruption and severe mood swing during "rebound" from the medication. She began taking Azstarys on November 23, 2022 to see if these side effects would be reduced. She took Azstarys for five days in a row and it seemed to work really well. It was very effective for self-regulation and attention, and the mood swings during rebound were less pronounced. She had closer-to-normal appetite; in other words, Azstarys did not result in the problematic appetite suppression we've experienced with stimulants. On November 25, 2022 she received a COVID booster and on November 27, she received a flu shot. The night of November 27, she began complaining that he face was stinging and a little itchy. By 9 pm, she was developing what looked like bruises, hives, burns or lesions on her face. We gave her Benadryl and that seemed to stop the reaction. She had never reacted to flu or covid vaccines before (beyond mild local soreness at the shot location), so we didn't understand what the cause of the lesions might be. On November 29, we gave her another Azstarys and she developed new lesions. The doctors were still unsure of what caused the reaction. Since the lesions appeared to be some sore of allergic reaction, we followed the doctors' guidance and gave her Zyrtec for two weeks. When we restarted Azstarys again, we kept her on the Zyrtec for another 2-3 weeks. When we took her off the Zyrtec, she did not have more lesions, so we continued Azstarys. Over the winter holidays, she did not take Azstarys, as she was taking it only for school. She did not take Azstarys regularly in January, and we took another break from it because she was sick (with a bad cold). We restarted it on February 1, 2023. On February 6, she started developing new lesions so we stopped Azstarys entirely. With some concern that is might be related to the dye in the Azstarys, we also removed all food with artificial dye from her diet. She stopped developing lesions. On March 5, she ate foot with artificial dye. The next day, she developed a new lesions. In addition to the pain of the lesions when they form, and even more concerning, the lesions have results in lasting (and, we fear, long-term) hyper-pigmentation (spots that are darker than the surrounding skin). Please contact me for more photos of the lesions.