Kowa Lands OPDP Untitled Letter Over YouTube Testimonials
The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) last week sent an untitled letter to Kowa Pharmaceuticals over claims made about its statin drug Livalo (pitavastatin) in a patient testimonial video posted to YouTube.So far in 2019 OPDP has issued five untitled letters and two warning letters to drugmakers over promotional materials for their products, matching the number sent by the office in 2018.
"This video is concerning from a public health perspective because it creates a misleading impression regarding the side effects a patient may experience as a result of Livalo treatment and deemphasizes the risks associated with taking the drug," FDA writes.
FDA notes that misrepresenting the risks of a drug such as Livalo is especially concerning as Livalo carries serious risks, including myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria. Livalo is also contraindicated in patients with hypersensitivity to any of its components, liver disease, coadministration with cyclosporine and in patients who are pregnant or lactating.
In the YouTube video, which has since been taken down, FDA says the company presented Livalo as a safer alternative to other statins by only presenting testimonials from patients who experienced fewer side effects after switching to the drug.
The video featured testimonials and accompanying text from three patients, each of whom mentioned experiencing side effects with previous statins and reduced side effects with Livalo. For example, a testimonial attributed to Robert M. stated that the "first medication I went on came with a lot of side effects, so I tried other ones after that and it was even worse," before adding that he wished he had started on Livalo sooner "because I'm not having the side effects that I was having with other statins."
While the video includes a text message stating "individual results may vary," FDA says this does not negate the message implied from the testimonials and that the agency is not aware of any evidence that switching to Livalo from other statins would lead reduced side effects and asks the company to submit any evidence it has to support such a claim.
FDA also notes that Livalo carries some of the same serious risks as other statins.
In addition to misrepresenting Livalo's risks, FDA says the video fails to include other information about the drug's contraindications, warnings, precautions and adverse reactions in a prominent manner.
"The overall effect of disclosing risk information in this manner as scrolling text relegated to the bottom of the video, along with the simultaneous presentation of the patient testimonials, undermines the communication of risk information and thereby misleadingly minimizes the risks associated with the use of Livalo," FDA writes.
In response to the untitled letter, FDA asks that Kowa stop distributing the video and respond to the letter within two weeks with a list of all other promotional materials for Livalo that contain the same violative materials as well as a plan for stopping distribution of those materials.
FDA