[Updated 2/26/10, 1:30 pm. See below.] The FDA has told San Diego-based Novalar to stop using a misleading patient brochure promoting the company’s injectible dental drug, phentolamine mesylate, which is intended to help dissipate the prolonged numb sensation of dental anesthetic. The brochure omits and minimizes the risks of the drug while overstating its benefits, the FDA wrote in a letter to the company.
[Updates with Novalar comment] A Novalar spokeswoman had no immediate comment. This afternoon, Novalar CEO Donna Janson says the FDA’s comments are specific to a promotional brochure that is obsolete. “It’s an earlier version that’s no longer in use,” Janson told Bruce in a call from the Chicago Dental Society Midwinter Meeting. Novalar has been consulting with the agency on the language of its current promotional materials, and Janson says, “It’s the company’s responsibility to make sure that everything that’s out there is in compliance.”
The drug, which is marketed as OraVerse, is privately-held Novalar’s only product. It is approved for reversing anesthesia of the lip and tongue after dental procedures. The drug’s active ingredient is a common vasodilator that increases the blood flow to the lips, cheeks, gum, and tongue so that the dental anesthetic wears off quicker.
Novalar, which is backed by Domain Associates, introduced the drug in six test markets almost exactly a year ago. Annual sales could reach $400 million if 20 percent of the nation’s dentists use the drug, the company has said. But as Luke reported in October, the drug has been slow to catch on. (I also asked the company earlier today for an update.)
The FDA told Novalar that the brochure is misleading because it gives greater prominence to information about the effectiveness of the drug than to its side effects. Efficacy information is presented in large, colorful letters while risk information is presented in a small, black font.
The brochure omits some common adverse reactions experienced with the drug, the FDA said. Though the brochure discloses that cardiovascular events may occur, it does not disclose such side effects as injection site pain, post-procedural pain, and headache.
In addition, the brochure misleadingly implies the drug is approved for children as young as 4 when in fact it is not approved for children under 6, according to the FDA letter, which was posted to the agency’s website Feb. 2.
The brochure overstates the efficacy of phentolamine mesylate by claiming the drug will increase patients’ “comfort” and help them “return to normal,” the FDA wrote. The agency said there was no evidence for these claims. In fact, the FDA said, the drug may have the opposite result.
Side effects from phentolamine mesylate “may prevent a patient from feeling comfortable” and “may also prevent a patient’s return to normal,” the agency wrote.
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