May 12, 2008 -- The FDA has approved OraVerse, the first drug indicated for reversing the effects of local anesthesia used by dentists.
According to Novalar Pharmaceuticals, the drug company that makes OraVerse, the FDA approved OraVerse's use in adults and children based on several clinical studies in which patients got an injection of OraVerse or a placebo after undergoing dental procedures under local anesthetics.
In the clinical studies, the patients who got OraVerse regained normal sensation in their lips faster than those who got the placebo. Within an hour after getting OraVerse, 41% of the patients had normal sensation in their lower lip, compared with 7% of those who got the placebo. And 59% of the OraVerse patients regained normal sensation in their upper lip within an hour after getting OraVerse, compared with 12% of those who got the placebo.
A Novalar news release states that no serious side effects were seen in the clinical studies; the most common side effect was pain at the injection site.
Novalar notes that although fast heart rate (tachycardia) and cardiac arrhythmia may occur when drugs like OraVerse are given intravenously, such problems are uncommon when OraVerse is injected into the gums.
OraVerse isn't recommended for use in children younger than 6 or children under 33 pounds.