USA – Vanda Lands OPDP Warning Letter Over Risk Info on Website

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) last week sent a warning letter to Vanda Pharmaceuticals for failing to list risk information on a webpage for two of its drugs.

With this latest warning letter, OPDP has issued a total of two warning letters and five untitled letters in 2018, up from the three warning letters and two untitled letters it sent last year.

In the letter, FDA writes that the “Products” page on Vanda’s website fails to include any risk information for the two drugs presented on the page, Hetlioz (tasimelteon)‎, which is indicated to treat non-24-hour sleep-wake disorder, and Fanapt (iloperidone), an antipsychotic approved to treat adults with schizophrenia.

FDA says the omission of risk information for the two drugs misbrands them under the Food, Drug and Cosmetic Act and “creates a misleading impression” about the drugs’ safety.

“Of particular concern 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,” FDA writes…