The Food and Drug Administration warned medical professionals on Tuesday of the risk of adverse reactions at the injection site in patients given alcohol dependence drug naltrexone.
Regulators said they received 196 reports of injection site reactions and are now working with the drug's manufacturers to make changes to the prescribing information based on those reports.
Naltrexone, which is made by
and marketed in the U.S. by
under the brand name Vivitrol, is given as an intramuscular gluteal injection.
Per a MedWatch alert posted on its Web site, the FDA said reports of injection site reactions, include cellulitis, abscess and necrosis, among other things. Sixteen patients have required surgical intervention.
The FDA reminded health care professionals that naltrexone shouldn't be administered intravenously, subcutaneously, or inadvertently into fatty tissue. The agency said physicians should promptly refer patients with worsening injection site reactions to a surgeon.
Last week Alkermes reported gross sales of $4.8 million from Vivitrol for the second quarter. It recently announced that its partner cilag GmbH International, a subsidiary of
Johnson & Johnson
received approval for the drug in Russia for alcohol dependence.
It also recently initiated a multicenter, 200-patient registration study of the drug for the treatment of painkiller dependence.
Alkermes shares closed down 44 cents or 2.6%, while Cephalon shares closed the session up four cents.