Lump after vivitrol injection

August 13, 2008

By: AboutLawsuits

The FDA has issued an alert to healthcare professionals about the risk of adverse skin reactions for individuals who receive an injection of Vivitrol, a drug given to treat alcohol dependence.

According to information posted on the FDA website on Tuesday, the agency has received 196 reports of Vivitrol skin reactions in patients treated with anti-alcohol injection, including abscesses, cellulitis, pain, swelling, tenderness, redness, bruising, bleeding and necrosis. In addition, 16 of the reports involved surgical treatments, such as incision and drainage for abscesses (fluid-filled cavities) and removal of dead tissue (necrosis).

Vivitrol (naltrexone) is manufactured by Alkermes Inc. and marketed by Cephalon Inc. In April 2006, the FDA approved the drug for treatment of alcohol dependence in outpatients who can abstain from drinking prior to initiation of therapy. It is the market name of extended release injectable suspension formulation of naltrexone. It is given by a healthcare provider as part of a comprehensive therapy for alcoholism, including group therapy or counseling along with medication. Annual sales of the drug are over $450 million.

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By binding to opioid receptors in the brain, Vivitrol dampens the desire for alcohol and may reduce the sensation of pleasure a person gets from drinking alcohol. The non-addictive drug has been shown to reduce the number of drinking days in a month for alcoholics and the number of heavy drinking days.

Vivitrol is administered as an intramuscular gluteal injection once a month in a 380 mg dose and is released into the body at a controlled rate. The FDA warned that the drug should not be injected subcutaneously, intravenously or into fatty tissue, as this increases the risk of tissue damage. Healthcare providers have also been urged to use a special 1 ½” needle supplied with the drug for injection and to make sure they inject the drug properly at the correct dosage.

The FDA has also asked physicians to instruct patients to monitor Vivitrol injection sites for reactions, such as redness, pain, swelling, itching and bruising. If symptoms persist or worsen within two weeks, they should be referred to a surgeon. Tissue damage may result in fluid-filled cavities (known as an abscess) or death of the tissue (known as necrosis). Women are more at risk of Vivitrol skin reactions, because they have a larger amount of gluteal fatty tissue.

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"VIVITROL injections may be followed by pain, tenderness, induration, swelling, erythema, bruising, or pruritus; however, in some cases injection site reactions may be very severe. In the clinical trials, one patient developed an area of induration that continued to enlarge after 4 weeks, with subsequent development of necrotic tissue that required surgical excision. In the postmarketing period, additional cases of injection site reaction with features including induration, cellulitis, hematoma, abscess, sterile abscess, and necrosis, have been reported. Some cases required surgical intervention, including debridement of necrotic tissue. Some cases resulted in significant scarring. The reported cases occurred primarily in female patients.

"VIVITROL is administered as an intramuscular gluteal injection, and inadvertent subcutaneous injection of VIVITROL may increase the likelihood of severe injection site reactions. The needles provided in the carton are customized needles. VIVITROL must not be injected using any other needle. The needle lengths (either 1 1/2 inches or 2 inches) may not be adequate in every patient because of body habitus. Body habitus should be assessed prior to each injection for each patient to assure that the proper needle is selected and that the needle length is adequate for intramuscular administration. For patients with a larger amount of subcutaneous tissue overlying the gluteal muscle, the administering healthcare provider may utilize the supplied 2-inch needle with needle protection device to help ensure that the injectate reaches the intramuscular mass. For very lean patients, the 1 1/2 -inch needle may be appropriate to prevent the needle contacting the periosteum. Either needle may be used for patients with average body habitus. Healthcare providers should ensure that the VIVITROL injection is given correctly, and should consider alternate treatment for those patients whose body habitus precludes an intramuscular gluteal injection with one of the provided needles.

"Patients should be informed that any concerning injection site reactions should be brought to the attention of the healthcare provider [see Patient Counseling Information (17)]. Patients exhibiting signs of abscess, cellulitis, necrosis, or extensive swelling should be evaluated by a physician to determine if referral to a surgeon is warranted."

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