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# Sponsored Links Misbrand Eton Alkindi Sprinkle: OPDP
- URL: https://www.fdaweb.com/sponsored-links-misbrand-eton-alkindi-sprinkle-opdp/
- Published: 2021-08-19T12:00:00.000Z
- Updated: 2026-09-14T17:11:03.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149972

The CDER Office of Prescription Drug Promotion (OPDP) says online sponsored links for Eton Pharmaceuticals’ Alkindi Sprinkle (hydrocortisone) oral granules are false and misleading because they present information about the drug’s benefits and fail to include any risk information. An 8/4 Notice of Violation says the 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 population, and may cause serious adverse reactions such as adrenal crisis, infections, and growth retardation, among others.”

The letter says Alkindi Sprinkle is indicated as replacement therapy in pediatric patients with adrenocortical insufficiency. It is contraindicated in patients with hypersensitivity to hydrocortisone or any of the ingredients in Alkindi Sprinkle. The labeling contains Warnings and Precautions about adrenal crisis, infection, growth retardation, and Cushing’s Syndrome due to the use of excessive doses of corticosteroids.

OPDP says that by omitting the risks associated with Alkindi Sprinkle, the sponsored links fail to provide material information about the consequences that may result from using the product and create a misleading impression about its safety.

Eton was told to respond with a list of all Alkindi Sprinkle promotional communications that contain representations like those described in the letter, with a plan for discontinuing the use of such communications or for ceasing distribution of Alkindi Sprinkle.