Tuesday, August 12, 2008

FDA warns of complications if Alkermes’ Vivitrol is injected incorrectly

By Mass High Tech Staff

In an alert posted today, the U.S. Food and Drug Administration is warning of potential adverse reactions to shots of the alcohol dependence drug Vivitrol, from Cambridge-based Alkermes Inc.
 
According to the report, the FDA has received notice from 196 patients of reactions at the injection site, with such complications as cellulitis, induration, hematoma, abscess, sterile abscess and necrosis. The FDA said that 16 patients required surgery ranging from incision and drainage in the cases of abscesses to extensive surgical debridement in the cases that resulted in tissue necrosis.

Vivitrol is supposed to be administered as an intramuscular gluteal injection. On its website, the FDA warns that the drug should not be administered intravenously, subcutaneously or inadvertently into fatty tissue. Health-care providers should use the pre-packaged 1½-inch needle that is specifically designed for Vivitrol, the FDA said.

Vivitrol, an extended-release version of the generic drug naltrexone, is approved to treat alcohol dependence. In the U.S., Vivitrol is marketed primarily by Frazer, Pa.-based Cephalon Inc.

Last week Alkermes reported that Vivitrol had been approved by Russian regulatory authorities. And in June, Alkermes reported its start of a Phase 3 clinical trial of its Vivitrol long-term treatment for opioid dependence. Alkermes employs 610 workers and reported 2008 net income of $167 million on revenue of $240.7 million.