The U.K. pharma marketing watchdog has slammed AGB Pharma for misleadingly implying a lack of fertility considerations for its melatonin medicine, Adaflex.
A healthcare professional complained to the self-regulatory watchdog, the PMCPA, about the omission of information on fertility warnings from Adaflex’s summary of product characteristics. AGB used the information in promotional materials from November 2023 to March 2025, leading the complainant to argue the omission was “a patient safety challenge.”
The company, a Swedish business that specializes in sleep health, disagreed with the complainant’s claim that the omission breached the U.K. drug marketing code. As AGB told the PMCPA, the fertility risk was theoretical and unproven—and based solely on incomplete animal data—when Adaflex won approval. AGB added that the marketing code doesn’t explicitly require the inclusion of fertility data.
While AGB added a fertility statement in April 2025, the company denied the change was a corrective measure. Rather, AGB said a focus on completeness and transparency drove the addition of the fertility information, reflecting a commitment to continuous improvement and to going beyond code obligations where appropriate.
AGB denied all the code breaches alleged by the complainant. The PMCPA sided with the complainant on each point, leading it to accuse the company of bringing discredit upon, or reducing confidence in, the pharmaceutical industry, its harshest censure.
The watchdog’s findings reflected its conclusion that text about fertility risk was “relevant precautionary information,” particularly because the drug might be used over prolonged periods. Adaflex is approved for the treatment of insomnia in children and adolescents with ADHD.
By including information on pregnancy and breastfeeding, while omitting a discussion of fertility, AGB could have implied an absence of considerations regarding fertility. Those factors led the PMCPA to rule that AGB breached the rule against providing misleading information, as well as the requirement to provide certain prescribing information in all promotional materials.
The potential for the omission to misleadingly imply a lack of fertility considerations for the medicine informed the ruling that AGB failed to maintain high standards. The conclusion that AGB had brought discredit on the industry reflected the potential for the omission to impact patient safety. That breach triggered the additional sanction of an ad communicating a high-level overview of the case.