Vivitrol Side Effects Updated for Risk of Injection Site Reactions

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The warnings about potential side effects of Vivitrol, a drug given to treat alcohol dependence, are being updated to include additional information about the risk of potentially serious injection site reactions.

The FDA and maker of the drug, Alkermes, sent a letter to healthcare professionals this week notifying them of updates to the Warnings, Information for Patients and Dosage and Administration sections of the Prescribing Information based on postmarketing reports of skin reactions with Vivitrol received prior to June 2009.

In 2008, the FDA reported that it had received 196 reports of Vivitrol injection site skin reactions in patients treated with the 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).

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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 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.

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.

Tags: Alkermes Inc, Cephalon, Vivitrol
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7 Comments

kay
My son was on a mandatory vivitrol shot – 4 mos later he is in the cancer center downtown with Leukemia.- anything on this ?
Amy
I required emergency surgery for appendicitis and bowel perforation. It was 2 weeks after a vivitrol injection. All the literature on vi vitriol states that it can be reversed if needed. My doctor told me it can’t be reversed. Obviously I had extremely severe pain that nothing relieved. I looked at the package insert and sure enough it says it can be reversed. I was not adequately informed of the risks with this medication.
AMBER
i just read it can cause hep c n hiv they never tell you that … i wouldnt take that junk
robert
I have been taking Vivitrol for @ 9 mos for alcohol dependency. With the exception of an occasional sore butt and a little swelling. I find the benefits far out-weigh the risks. I have had little to no desire to drink. With Vivitrol and regular a.a. meetings I have found abstinance to be relatively easy. I have been drinking at least a quart of vodka a day.And, despite being prone to seizures and death defying detoxes I have not been able to stay clean. As far as I’m concerned the benefits of The injections to be an excellent tool in my recovery
Teresa
I too experienced a very painful injection site…so much that I couldn’t bear for my husband to touch it in a normal embrace. But also consider this: This drug should be taken with great caution! Keep in mind that Vivitrol blocks the effects of painkillers that are administered after surgery, whether the surgery is known to happen or on an emergency basis. I had gallbladder surgery 6 days after my 4-wk cycle of Vivitrol had expired. The surgeon had to make an old-fashioned incision of over 6 inches and closed it with 13 staples. I woke up after surgery in a living nightmare! Nothing they could give me had any effect on the pain. The pain was indescribable and I wished for death over and over. I believe this drug is given too freely and people should weigh ALL possible scenarios before they take the injection! You could be hit by a car or in any kind of accident at any time…
Troy
I have been taking the vivatrol injections for 7 months now. I am not to founf off it. It wears off after about 10 days and the cravings are back. The injection itself is the most painful thing I have ever experienced. The injection site remains extremely painful to sit or touch or lay on. So basically I am not in pain for two weeks out of each month and I do not think this is normal and I am seriously thinking about terminating the shot because the agony the bruising, swelling and pain which also inconviences me from using the bathroom to sleeping and to enjoying everyday things, Its not worth it, I am interested in being compensated for my pain or at least get it known out to the world that the shot is misleading and it is an excruiting amount of pain for two weeks out of every month . Thank you for your time.
Troy
I have been taking the vivatrol injections for 7 months now. I am not to founf off it. It wears off after about 10 days and the cravings are back. The injection itself is the most painful thing I have ever experienced. The injection site remains extremely painful to sit or touch or lay on. So basically I am not in pain for two weeks out of each month and I do not think this is normal and I am seriously thinking about terminating the shot because the agony the bruising, swelling and pain which also inconviences me from using the bathroom to sleeping and to enjoying everyday things, Its not worth it, I am interested in being compensated for my pain or at least get it known out to the world that the shot is misleading and it is an excruiting amount of pain for two weeks out of every month . Thank you for your time.

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