Drugs

Recorlev Web Pages ‘False or Misleading’: FDA

The CDER Office of Prescription Drug Promotion (OPDP) says pages at the Xeris Recorlev Web site make false or misleading claims and representations about the safety and efficacy of Recorlev (levoketoconazole) tablets, oral. A 6/7 Notice of Violation says the violations “are especially concerning from a public health perspective because the promotional communications create a misleading impression regarding the safety and effectiveness of Recorlev, a drug with a number of serious and potentially life-threatening risks, including Boxed Warnings regarding the risks of hepatoxicity and QT prolongation.”

Recorlev is indicated to treat endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative.

OPDP says the firm’s use of data from the SONICS and LOGICS studies misleadingly overstates the drug’s efficacy. Also, it says, the Web pages minimize the serious and significant risks associated with using Recorlev. While acknowledging that side effects can occur, OPDP says, Xeris does not discuss information about the Boxed Warnings or specific side effects, including some that are potentially fatal.

“We acknowledge that risk information for Recorlev is presented separately” in another section of the Web pages, OPDP says. It adds that the “overall effect of this Web page’s presentation of risk information undermines the communication of the significant and potentially fatal risks associated with Recorlev and thereby misleadingly minimizes the risks associated with the use of Recorlev.”

Xeris was told to respond with a list of all Recorlev promotional communications that contain representations like those described in the letter and an explanation of any plan for discontinuing the use of such communications or halting distribution of Recorlev.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome