FDA Policy/General

Vanda Web Page for 2 Drugs ‘False, Misleading’: OPDP

A Vanda Pharmaceuticals Web page for Fanapt (iloperidone) tablets for oral use and Hetlioz (tasimelteon) capsules for oral use presents information about the two drugs but fails to include any risk information about either one, according to a 10/22 Warning Letter issued by CDER’s Office of Prescription Drug Promotion (OPDP). The letter says the Web page is concerning from a public health perspective because it creates a misleading impression about the safety of Fanapt and Hetlioz. “Of particular concern,” it says, “is that Fanapt is a drug that bears a Boxed Warning due to serious, life-threatening risks, including increased mortality in elderly patients with dementia-related psychosis, as well as numerous other warnings.”

According to its labeling, OPDP says, Fanapt is indicated for treating schizophrenia in adults. The labeling includes Contraindications and Warnings and Precautions in addition to the Boxed Warning.

Hetlioz is indicated for treating non-24-hour sleep-wake disorder. The label has a Warnings and Precautions section with risk information for somnolence.

The OPDP letter says the company Web page includes claims and/or representations about the uses and/or benefits of the two drugs but fails to communicate any risk information abut them. While the page tells where the full prescribing information for each drug can be found, the letter says, that does not mitigate the omission of risk information from the Web page itself.

“By omitting the risks associated with Fanapt and Hetlioz, the Web page fails to provide material information about the consequences that may result from the use of the drugs and creates a misleading impression about the drugs’ safety,” OPDP says. “This misleading presentation is especially problematic from a public health perspective due to the serious and potentially life-threatening risks associated with the drugs, such as those contained in Fanapt’s Boxed Warning.”

Vanda was told to immediately stop misbranding Fanapt and Hetlioz and/or stop introducing the misbranded drugs into interstate commerce. It was told to respond with a list of violative materials and a plan for discontinuing their use. It also was told to submit a comprehensive action plan for disseminating truthful, non-misleading, and complete corrective messages about the issues discussed in the letter to the audiences that received the violative promotional materials.

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