The US Food and Drug Administration (FDA) last week sent pharmaceutical company Pernix Therapeutics Holdings a warning indicating that one of its marketing pieces failed to contain sufficient warnings, contraindications and risk information otherwise contained in the drug's FDA-approved labeling, making it misbranded.
The warning, made public by FDA's Office of Prescription Drug Promotion (OPDP) on 20 December 2013 in the form of an Untitled Letter, refers to Pernix's drug Cedax (ceftibuten), an antibiotic indicated for use in mild-to-moderate infections caused by specific bacteria.
While the drug is intended for use in chronic bronchitis, acute bacterial otitis media, pharyngitis and tonsillitis, its labeling also contains prominent statements regarding its reduced effectiveness in specific situations. For example, in acute bacterial otitis media, use of Cedax was 23% less effective than a control drug. As a result, "ceftibuten should be given empirically only when adequate antimicrobial coverage against Streptococcus pneumoniae has been previously administered," FDA wrote.
In addition, the drug is also contraindicated for use in patients known to be allergic to caphalosporins, and additional warnings note its ability to cause hypersensitivity and other serious side effects in patients.
The problem, OPDP explained in an Untitled Letter-an official warning that asks for voluntary compliance but does not threaten pending regulatory action against a company-is that a webpage maintained by the company listed none of those contraindications, warnings or caveats.
"By omitting the serious risks associated with Cedax, the webpage misleadingly suggests that Cedax is safer than has been demonstrated," FDA charged in its letter.
While the referenced webpage did contain a link to the full prescribing information, FDA maintained that this was insufficient and did "not mitigate the complete omission of important risk information from the webpage."
The company was also chided for including in its marketing materials a child who FDA said appeared to be less than 12 years of age. The drug has only obtained approval for use in patients 12 years and older, FDA noted, and even then certain weight requirements affect dosing.
Further, FDA expressed its displeasure that Pernix had failed to submit to FDA its marketing material under Form FDA-2253, as required by regulation (21 CFR 314.81(b)(3)(i)).
Regulators requested that the company immediately bring its website into compliance with FDA regulations and the terms of its own labeling and reply to OPDP's letter by 7 January 2013.
At the time of this article's publication, Pernix's webpage for Cedax has been temporarily replaced with a direct link to Cedax's FDA-approved product information (PI).
FDA's Untitled Letter to Pernix
FDA Screen Grab of the Webpage