In the first warning letter sent since President Donald J. Trump took office, the Food and Drug Administration (FDA) cautioned the maker of a weight loss drug about false advertising.
A 60-second television ad for Orexigen Therapeutics Inc.’s Contrave failed to mention several key risks of the drug, the agency said, including the failure to inform viewers that the drug is not appropriate for those with uncontrolled hypertension, seizure disorder, bulimia or anorexia, those who are pregnant, and individuals who recently stopped drinking abruptly.
The ad “creates a misleading impression about the safety of Contrave,” the FDA wrote, despite statements such as “Contrave is not for everyone” and “Other side effects may occur.” These statements were insufficient to convey the specific risk information associated with the drug and “did not mitigate the omission of these important risks from the TV ad,” the agency explained. “By omitting serious risks associated with Contrave, the TV ad misleadingly suggests that Contrave is safer than has been demonstrated.”
Making the ad even more misleading, important risk information was communicated in the visual portion of the TV ad with unrelated risk information in competing audio messages, the FDA said.
“For example, the TV ad discloses important risk information regarding the warning and precaution for the potential risk of hypoglycemia in patients with type 2 diabetes only as a SUPER, although, television advertisements shall include information relating to the major side effects and contraindications of the advertised drugs in the audio or audio and visual parts of the presentation,” according to the letter.
In addition, the TV ad disclosed important risk information about the contraindication for concomitant opioid use in the audio portion of the proposed TV ad simultaneously with a SUPER containing unrelated risk information about the most common adverse reactions.
“The overall effect of disclosing important risk information in SUPERs only, along with the simultaneous presentation of SUPERs and competing audio messages, undermines the communication of important risk information and thereby misleadingly minimizes the risks associated with the use of Contrave,” the FDA wrote. “The presentation in the video is especially problematic from a public health perspective given the serious and potentially life-threatening risks associated with the drug.”
Ordering Orexigen to immediately cease its violations of the Food, Drug & Cosmetic Act (FDCA), the letter requested that the drugmaker explain how it plans to discontinue using the violative materials.
To read the FDA’s letter, click here.
Why it matters: The FDA took issue not only with the advertiser’s failure to disclose a number of serious risks but also with the way it presented some of the drug’s risks by simultaneously presenting a visual message about the most common adverse reactions to the drug while playing an audio message about not using it with opioids. The result, according to the FDA: multiple violations of the FDCA.