OPDP Enforcement Letter to Eton Pharmaceuticals Cites Omission of Risk Info in Sponsored Links

Aug. 30, 2021 – In an Aug. 9 Untitled Letter, FDA’s Office of Prescription Drug Promotion (OPDP) cited Eton Pharmaceuticals Inc. for presenting benefit information in sponsored links for Alkindi® Sprinkle (hydrocortisone) oral granules without including any risk information about the product, which “is used in a vulnerable pediatric population” and may cause serious adverse reactions.

Including benefit information about a drug while failing to reveal its risk information in promotional materials is a commonly cited violation in OPDP enforcement letters. In this case, Eton is cited for failing to provide contraindications and common risks associated with Alkindi Sprinkle, including warnings and precautions listed in the product’s PI: adrenal crisis, infection, growth retardation, Cushing’s Syndrome due to excessive use of corticosteroids, decrease in bone mineral density, psychiatric adverse reactions, ophthalmic adverse reactions, and gastrointestinal adverse reactions.

OPDP cites specific examples of sponsored links that are problematic because they highlight drug benefits without mentioning risks:

  • Hydrocortisone Oral Granules I Alkindi Sprinkle Now Available Accurate and individualized dosing for infants and children with adrenal insufficiency. Strengths as low as 0.5 mg without splitting or manipulation.”
  • “Hydrocortisone Oral Granules I Cortisol Replacement Therapy ALKINDI SPRINKLE: low-strength hydrocortisone for children with adrenal insufficiency. Individualized hydrocortisone dosing with no bitter taste, pill cutting or dissolving.”
  • “Alkindi Sprinkle for Kids I Micro-Granular Hydrocortisone Alkindi Sprinkle for pediatric adrenal insufficiency; strengths as low as 0.5 mg. No cutting, no splitting, just sprinkles for neonates and children < 17 years of age.”

“By omitting the risks associated with Alkindi Sprinkle, the sponsored links fail to provide material information about the consequences that may result from the use of Alkindi Sprinkle and create a misleading impression about the drug’s safety,” OPDP states.

This letter is the third Untitled Letter issued by OPDP in 2021; OPDP issued only two Untitled Letters in 2020.