Patients taking the injectable drug Vivitrol (naltrexone) might have serious skin reactions, according to federal regulators. The FDA has received almost 200 reports of skin problems from patients, 16 of whom required surgery as a result.
The drug, which is used to treat alcoholism, can cause complications such as swelling, pain, bleeding, infection, skin abscesses, necrosis and other problems at the site of injection. Using a proper needle as well as avoiding injecting the drug into fatty tissue might alleviate these adverse reactions.
Vivitrol is made by Alkermes. Cephalon markets the drug. FDA is talking to the company about placing more prominent and stringent warnings on the drug label.
- see the BusinessWeek story
- read more from The Boston Globe
- get the scoop from The Street