Spanish pharma company Exeltis, which markets birth-control pill Slynd, was recently cited by American regulators for a paid Facebook post that omitted side-effect information.
The Food and Drug Administration put up notice this week that it took enforcement action against the drugmaker for the errant social media post, according to the untitled letter, dated August 11.
Slynd (drospirenone) contains a progestin, a synthetic form of progesterone, and is indicated for use by women to prevent pregnancy. The ad touted Slynd without communicating any of its contraindications, warnings, precautions or adverse events, wrote the FDA’s Office of Prescription Drug Promotion (OPDP).
Because it failed to provide this material information, the Slynd post “creates a misleading impression about the drug’s safety,” OPDP wrote.
Regulators called out several problems with the ad, which states that Slynd patients will have a menstrual period or bleeding that is predictable and “on a schedule.”
Scheduled bleeding is something which is expected during a menstrual cycle. However, for most patients in Slynd’s clinical studies, the occurrence of scheduled periods actually decreased, the letter pointed out.
Slynd has been associated with amenorrhea, or the absence of periods, as well as bleeding irregularities and other potential consequences. Many subjects reported unscheduled bleeding even after the first few months of taking the drug, regulators noted.
OPDP also scolded Exeltis for not submitting a copy of the post upon its initial publication, as required by federal rules.
In addition to ordering the company to remove the ad, as well as any others that contain similar misrepresentations, the letter gave the drugmaker’s head of medical affairs two weeks to respond to the concerns and to submit a plan for discontinuing use of such communications.
An Exeltis communications manager told MM+M the company “is actively working to address FDA’s comments in the untitled letter and will respond with an action plan due on or before September 1, 2023.”
It’s not the first time that misleading social media promotion by a women’s health-related drugmaker triggered an FDA letter.
In 2015, OPDP warned Canadian drugmaker Duchesnay about an Instagram post that influencer Kim Kardashian made in support of morning-sickness pill Diclegis.
Because Kardashian’s post had merely linked to Diclegis’ safety information, but failed to mention it, the mega-influencer had to issue a corrective ad that featured the full risk language, even acknowledging that simply including a link fell short of FDA rules.
While the summer has brought a slight uptick in OPDP activity, the Exeltis letter was one of only three promotion-related letters sent this year. That said, it’s the second instance this month the FDA has taken enforcement action, following the warning sent to AstraZeneca over a sales aid that made exaggerated efficacy claims for a COPD drug, and the third in a three-month span.
