Bristol Revising Tequin Website: FDA Says Statistics Overstate Efficacy
Executive Summary
Bristol-Myers Squibb is revising its website for the antibiotic Tequin in response to a letter from FDA challenging rates of efficacy reported on the site.
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Bristol-Myers Squibb is revising its website for the antibiotic Tequin in response to a letter from FDA challenging rates of efficacy reported on the site. The website "provides misleading efficacy rates for Tequin," FDA's drug advertising division maintained in an April 10 letter. The letter refers to material on the Tequin (gatifloxacin) site as of April 7. On April 10, Bristol removed most content from the website, leaving only a link to the full prescribing information. The site previously included a "Press Room," and sections dedicated to "Tequin Facts," "Disease Facts" and "Our Commitment." Bristol "utilizes efficacy rates of '>90% in acute bacterial exacerbation of chronic bronchitis, 96% in acute sinusitis and >97% in community-acquired pneumonia,'" FDA stated. These efficacy rates were found in multiple sections of the site, including a Jan. 5 press release announcing the Tequin approval and material in the "Tequin Facts" and "Disease Facts: Respiratory Tract Infections" sections. As of April 28, the press release was still accessible on Bristol's general corporate website. FDA charged that the website's efficacy rates for Tequin are overstated. "Clinical studies used as the basis of approval for Tequin demonstrated efficacy rates of 78%-88% for ABECB, 62%-88% for sinusitis and 73%-90% for CAP," FDA said. Labeling does not include clinical efficacy statistics. The different efficacy estimates apparently reflect differences in Bristol's and FDA's analyses of the pivotal trial data. The site also "misleadingly suggests" that Tequin is effective against resistant pathogens, the letter states, pointing to the statement: "For bacteria to develop resistance against Tequin, they must develop mutations in both enzymes. Thus, the chance of susceptible bacteria to develop resistance to Tequin is extremely low." Labeling reports cross-resistance between Tequin and some other fluoroquinolones, FDA said. FDA also noted that Tequin's potential to prolong the QTc interval "is not prominently displayed within the text." The revised Tequin website should be up in May, the company indicated. |