Almirall, a pharmaceutical company, has been reprimanded by the Information Review Board (IGN) for misleading advertising related to its allergy medication, Kestine (Ebastin). The core issue revolves around a public-facing advertisement featuring the phrase “Not tiring!” which IGN determined coudl misrepresent the potential side effect risks associated with the drug.

Concerns Over Kestine’s Marketing

Kestine is an over-the-counter antihistamine used to alleviate symptoms of allergic rhinitis, conjunctivitis, hives, and itching resulting from insect bites. The IGN’s critique stems from the fact that the drug’s official product information lists somnolence (drowsiness, sleepiness) as a common side effect.

IGN stated that, “Therefore, the advertising resistance can be misleading.”

“About the company, like You specify in the defense, not had the purpose of giving the claim that fatigue does not occur, you should have chosen a different wording…”

In its defense, Almirall argued that the product information also states that “Kestine has not given rise to sedation in clinical trials.” The company further elaborated on the definition of sedation, citing study results indicating that the active ingredient, ebastine, does not impair reaction time, psychomotor skills, attention, or driving ability.

Almirall Highlights Clinical Trial data

While acknowledging that somnolence is listed as a common side effect in the product summary, Almirall maintained that clinical data suggests somnolence is reported by approximately three percent of patients.

Almirall asserted that this figure is “near or on a par with placebo.”

The company also pointed to the approved package leaflet from the Swedish Medicines Agency, which lists drowsiness as a common side effect and fatigue as a rare side effect. Almirall argued that the “Not tiring!” claim is a consumer-pleasant interpretation of the product’s pharmacological profile.

Almirall stated, “The concept has thus did not have the purpose of giving the impression that fatigue never exists, but to describe that the product – as opposed to older antihistamines – does not produce the sedative effects that affect cognitive or motor function.” The company added that similar phrasing is used by other companies in the same product category.

Ethical Violations

Despite Almirall’s defense, IGN concluded that the advertisement violated the Ethical Regulations of the Pharmaceutical Industry. The Board emphasized the risk that consumers would interpret the claim literally, assuming that fatigue, somnolence, or drowsiness would not occur.

The board stated, “About the company, like You specify in the defense, not had the purpose of giving the claim that fatigue does not occur, you should have chosen a different wording or developed what you mean by the claim.”

consequently, Almirall has been fined SEK 55,000.