OPDP says phentermine site thin on details
The FDA's Office of Prescription Drug Promotion is taking drugmakers Citius and Akrimax to task for skimping on safety information on the website for weight-loss medication Suprenza.
The regulatory unit writes in its June 9 note that the site for dissolving phentermine tablet qualifies as false and misleading for reasons which include omitting material information, such as the “minimum initial body mass index (BMI) for which treatment with Suprenza is indicated, and the requisite presence of other risk factors in patients with an initial BMI greater than or equal to 27kg/m2.”
OPDP also notes that “click here for full Prescribing Information” does not “mitigate the misleading omission of risk information.”
The prescription weight-loss medication category is a rough one, as seen by the effort drugmakers Vivus and Arena are extending to grab patient and physician mindshare. OPDP's note to Citius and Akrimax notes that aesthetics are not a marketing tactic to pursue, and assails Suprenza's makers use of an image that showed a woman “squeezing together lettered blocks that spell the world ‘LEAN'.”
OPDP also objected to the site's phrase “It's time to take control . . . and get LEAN,” the URL leanonsuprenza.com and the sentence “Stay on course for success with The SUPRENZA LEAN Program.”
Although the word lean is being used in multiple ways, OPDP writes that overall impact of this language “misleadingly suggests that patients will become “LEAN” as a result of therapy with Suprenza” and that this is a problem because FDA does not have “substantial evidence or substantial clinical experience to support this implication.”
OPDP's letter says the lean language is also bothersome because it is “an amorphous cosmetic descriptor, commonly understood to mean thin, slim or slender that was not associated with any clinical endpoints in the studies of phentermine.”
The writers had the approved PI handy when drafting the note and acknowledge that drug studies did show that short-term clinical trial results among adults given dietary instruction who took “anoretic” drugs lost more than patients who had a diet but received a placebo medication.
OPDP said it's open to the lean claims as long as the drugmakers have supporting data they can send to the FDA for its consideration.