FDA warns Dentsply about advertising violations

Jan 18, 2011

The U.S. Food and Drug Administration issued a warning letter January 4 to Dentsply Pharmaceutical about the content of advertising material for its periodontal anesthetic product.

After reviewing two professional direct mailers and a professional journal advertisement for the drug Oraqix (a lidocaine and prilocaine 2.5%/2.5% periodontal gel), a needle-free anesthetic for adults used in scaling and root planing (SRP), the FDA said the marketing materials misbrand the drug in violation of the Federal Food, Drug, and Cosmetic Act.

The ads are "false or misleading because they omit and minimize risk information associated with Oraqix, overstate the efficacy, and broaden the indication of the drug," the FDA warning letter noted.

"Our pharmaceutical division did receive a letter from the FDA alleging that certain publications' journal advertisements featuring the Oraqix product were misleading," Michele Mummert, manager of corporate communications at Dentsply International, told DrBicuspid.com. "We withdrew those advertisements and intend to engage the FDA to resolve the issue."

While the FDA acknowledges a statement at the bottom of the mailers directing attention to prescribing information, the agency views the lack of risk information on the direct mailers themselves as a violation. In addition, the journal ad presents only limited risk information and does not include important warnings about anaphylaxis, severe hepatic disease, or other common adverse reactions to the drug, the FDA said.

The agency also found that language in the journal ad describing superiority over injectable anesthetics because of greater patient comfort was unsubstantiated. While the letter acknowledges that there is initially less discomfort when using the blunt-tipped applicator associated with Oraqix than when using a needle, there is no difference in the comfort level during the actual SRP procedure, according to the FDA.

Other language -- such as "changes everything" and "saves time" -- was viewed by the FDA as an "overstatement of efficacy." A lack of specificity in statements such as "A lot of people won't even let me clean their teeth without Oraqix" was also cited as a "broadening of indication" since it suggests that it is safe and effective for all patients getting routine cleanings. According to the agency, the product is only approved as a periodontal pocket anesthetic during SRP procedures in adult patients.

Dentsply must provide a written response to the FDA's letter by January 19, 2011. In the meantime, the FDA's Division of Drug Marketing, Advertising, and Communications is requesting that the company immediately cease disseminating these marketing materials. Further, the company is expected to create a plan for issuing corrective statements to the parties who had received the advertisements.

Failure to correct the violations may result in FDA regulatory action, including seizure or injunction, without further notice, the agency concluded.

"We strive and intend to comply with FDA regulations and guidelines, and will certainly take measures to address the concerns," Mummert said. "We feel that the allegations have no direct impact on the actual product or the product's quality."