FDA rejects OraVerse brochure

Feb 25, 2010

The U.S. FDA has asked Novalar Pharmaceuticals to stop distributing a patient brochure for the drug OraVerse (phentolamine mesylate), which it markets for reversing the effects of local anesthesia.

The brochure violates federal law by minimizing risks, overstating efficacy, and implying it is approved for children younger than 6 years old, the FDA said in a letter to Novalar.

OraVerse did not respond to a request for comment from DrBicuspid.com.

While the brochure acknowledged that OraVerse can cause tachycardia, bradycardia, and cardiac arrhythmias, it doesn't disclose the possibilities of injection site pain, postprocedural pain, and headache. What side effects the brochure does mention are in a small black font and technical language, while the benefits of the drug are touted in layman's language written in large colorful letters.

The brochure also states "the safety and effectiveness of OraVerse have been successfully demonstrated through clinical trials involving pediatric, adolescent and adult patients ages 4 through 92." That assertion contrasts with another passage on the brochure, which states the claim actually allowed by the FDA: "Proven safe and effective for adults and children aged 6 and older and weighing more than 33 lbs."

Finally, the brochure exaggerates the benefits of the drug by saying that it provides "comfort" and can return patients to "normal" activities with "peace of mind," according to the FDA. The drug has only been shown to diminish problems such as numbness and drooling, the agency said. It has asked Novalar to report any similar promotional materials and explain how it will stop using them.