Regulatory Focus™ > News Articles > OPDP Releases Third Untitled Letter in as Many Weeks

OPDP Releases Third Untitled Letter in as Many Weeks

Posted 14 November 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has issued a warning to US WorldMeds regarding the online marketing of one of its drugs, Revonto, calling claims made by the company misleading and unsubstantiated.


The warning, known as an Untitled Letter, is the third posted by OPDP since 24 October. Affected companies include Sunovion Pharmaceutical and Daiichi Sankyo, while a fourth, Aegerion Pharmaceuticals, was sent a Warning Letter.

In its Untitled Letter to US WorldMeds, OPDP calls attention to Revonto, a drug approved by FDA to manage fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia. The rare condition sometimes occurs after the administration of anesthesia, resulting in a life-threatening event in which the body's metabolism outpaces its supply of oxygen and ability to remove carbon dioxide.

Revonto is to be used as an adjunct to other supportive measures to manage the condition. In addition, use of the drug is associated with serious warnings such as the potential for tissue necrosis, respiratory depression, loss of strength and cardiovascular events.

Unsubstantiated Claims

And while Revonto is undoubtedly useful to doctors looking to treat patients with malignant hyperthermia, FDA said the company's marketing of the drug on its website currently serves to imply that it is superior to other treatments for the condition. FDA said there were no references or comparative data to substantiate the claim that Revonto "improved ease of reconstitution."

"If you have data to support these claims, please submit them to FDA for review," FDA added.

OPDP also alleged the Revonto website served to omit or otherwise minimize the risks of using the product. The agency said several of the drug's warnings and precautions were omitted from the website, such as the need to monitor vital signs due to skeletal muscle weakness, respiratory depression, and other metabolic and clinical signs.

Though FDA noted that there were links to the full prescribing information on the webpage, those links did "not mitigate the misleading impression" to the satisfaction of FDA.

Unfair Balance

The company was also hit for what FDA called a violation of its fair balance standard.

"This webpage prominently presents efficacy claims in large, bold, and colorful font and graphics, on the top portion of each page," FDA observed. "In contrast, information about the risks associated with Revonto are relegated to the bottom of the page, below the site map, and written in single-spaced paragraph format."

The presentation served to minimize the risks of the drug relative to its benefits, FDA contended, adding that the company should immediately cease the dissemination of the promotional materials and respond to FDA's letter.

As of the time of this article's publication, the company appears to have removed the disputed claims from its website.

Untitled Letter

PDF of the Website

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