On August 9, 2021, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent its third untitled letter of the year to Eton Pharmaceuticals over sponsored links for Alkindi Sprinkle, the company’s pediatric adrenocortical insufficiency treatment.
Alkindi Sprinkle is indicated as replacement therapy in pediatric patients with adrenocortical insufficiency but is contraindicated in patients with hypersensitivity to hydrocortisone or any other ingredients of Alkindi Sprinkle. Therefore, the FDA-approved product labeling contains warnings and precautions regarding adrenal crisis infection, growth retardation, Cushing’s Syndrome due to use of excessive doses of corticosteroids, decrease in bone mineral density, psychiatric adverse reactions, ophthalmic adverse reactions, and gastrointestinal adverse reactions. According to the untitled letter, the most common adverse reactions include fluid retention, alteration in glucose tolerance, and increased appetite and weight gain.
The untitled letter mentions ten example sponsored links for the drug, each of which promote the drug for its intended use and highlighting the potential benefits without mentioning any contraindications or other warnings/precautions related to the drug. Therefore, OPDP felt that the sponsored links were “false or misleading in that they present information about the benefits of Alkindi Sprinkle, but fail to include any risk information about the drug.” Based on the lack of risk information, the product is misbranded under the Federal Food, Drug, and Cosmetic Act.
In the letter, OPDP notes that “the determination of whether a promotional communication is misleading includes, among other things, not only representations made or suggested in the promotional communication, but also the extent to which the promotional communication fails to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the promotional communication.”
OPDP noted that other sponsored links with language such as “No cutting, no splitting, just sprinkles for neonates and children <17 years of age” and “Alkindi Sprinkle is the accurate, hassle-free hydrocortisone granules for kids” also lacked any corresponding risk information to satisfy fair balance requirements were also violative.
“These violations are especially concerning from a public health perspective because the promotional communications create a misleading impression about the safety of Alkindi Sprinkle, a drug that is used in a vulnerable pediatric patient population, and may cause serious adverse reactions such as adrenal crisis, infections, and growth retardation, among others,” OPDP wrote.
FDA asked for Eton to provide a plan for discontinuing violative communications within 15 days before closing the letter by stating, “the concerns discussed in this letter do not necessarily constitute an exhaustive list of potential violations” and put the onus on Eton to “ensure compliance with each applicable requirement of the FD&C Act and FDA implementing regulations.”