Keeping up with the FDA: reality TV star’s tweets on morning sickness pill amount to misbranding

Promotion of a morning sickness pill in social media postings of reality television star Kim Kardashian constitute violations of the federal Food, Drug and Cosmetic Act (FDC Act) because the claims omit risks that are associated with the use of the drug. The FDA Office of Prescription Drug Promotion (OPDP) asked Duchesnay, Inc., the pharmaceutical company behind DICLEGIS®, to immediately cease the misbranding activity or the introduction of the drug into interstate commerce.

DICLEGIS

The FDA-approved labeling for DICLEGIS (doxylamine succinate and pyridoxine hydrochloride), delayed release tablets for oral use, includes the following indication: “DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative treatment.” The approved labeling also includes language regarding the drug’s limitations of use such as: it has not been studied in women with hyperemesis gravidarum, an uncommon and severe condition in some pregnant women causing prolonged vomiting; it is contraindicated in women with certain known, listed hypersensitivities; it could affect mental alertness and certain concomitant medical conditions; and adverse reactions have been noted, including somnolence.

The OPDP noted that in November of 2013, it communicated to Duchesnay that an announcement of the release of DICLEGIS was false or misleading because it omitted all the risks associated with the drug. According to the OPDP, the posting is violative of the FDC Act (21 U.S.C. 352(a), (n); 321(n); 331(a)) in that “promotional materials are misleading if they fail to reveal facts that are material in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials.”

Social media posts

The focus of the OPDP’s concern are representations of DICLEGIS made on Kardashian’s verified Twitter, Facebook, and Instagram accounts, which included claims that her physician prescribed her DICLEGIS, she “felt a lot better,” and “most importantly, it’s been studied and there was no increased risk to the baby.” Kardashian also announced that she was “partnering with Duchesnay USA to raise awareness about treating morning sickness.”

Omission, requested action

“The social media post, however, entirely omits all risk information,” according to the OPDP. Although the office notes that the post includes a reference to the DICLEGIS website, which includes all relevant safety and risk information, the OPDP found that the post itself is misleading because it fails to present all the risk information and “suggests that it is safer than it has been demonstrated.”

As such, the OPDP asked Duchesnay to either immediately cease the misbranding activity or pull the misbranded product from interstate commerce altogether. Additionally, the OPDP asked Duchesnay to respond to this request in writing on or before August 21, 2015, and include a plan for the discontinuation of the promotional postings or the distribution of the product. The agency added, “to the extent possible corrective messaging should be distributed using the same media, and generally for the same duration of time and with the same frequency that the violative promotional material was disseminated.” Failure to carry out these requests, the FDA office warned, could result in regulatory action against the company.