FDA Warns of Vivitrol Skin Reactions
Published: August 13th, 2008
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.
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.
Related Posts
- Stevens Johnson Syndrome Drug Reaction Took the Life of Former NBA Star (6/23/2010)
- Vivitrol Side Effects Updated for Risk of Injection Site Reactions (5/5/2010)
- Intelence Side Effects Linked to Stevens-Johnson Syndrome Skin Reactions (8/31/2009)
- Skin Care Product Recall: Risk of Bacterial Contamination (6/9/2009)
- Chantix Side Effects Examined by FDA for Skin Reactions and Accidents (6/5/2009)
Comment by katie on 14 August 2008:
Anyone know of any lawsuits that have been filed involving Vivitrol? I am one of the 16 people who had to have two surgeries post-injection.
Comment by Jennifer on 30 August 2008:
I don’t know of any lawsiuts filed, however I just received my second shot on August 26 and am very upset that my doctor’s office made no mention of this FDA warning. And, oh by the way, I have a very large, swollen area – about the size of a tennis ball – around my injection site almost a week later.
Comment by Debbie on 19 November 2008:
I have recieved 2 injections so far and have developed arash on my lower legs that itches like crazy. It has not appeared around my injection site (no reaction at all there).
Comment by Tracey on 18 March 2009:
Katie- I have also had to have many procedures, including surgery to remove a mango-sized mass that developed at the injection site. Injection end of May and surgery end of July. I am have done a lot of research and have some ideas.
I have tried to find others that have experienced problems. When I first reported it, I was one of two that have had to have surgery. NOw it sounds like there are many more.
Comment by Angela on 11 July 2009:
I am having the same thing today I haven’t been to the Dr yet but the lump is getting larger after two weeks and it is painful today and red. The nurse said it would go away in a few weeks but it hasn’t I guess I will seek a second opinion.
Comment by Angela on 19 August 2009:
Hi,
I had necrosis and had to have surgery to.
Comment by free4today on 16 September 2009:
I am currently taking vivatrol injections. The next one will be my 7th shot. I was just curious about the comment that katie and Tracey left. I also have a big sore lump where the shot was given and it’s been 2 and a half months ago and it’s still here, I told the nurse that gave me the shot and she just said rub it, it will go away, but it has’nt. I’m a little concerned now that it hurts and I can feel the lump. what did you do to get the surgery to have it removed, I would like to have this lump removed from my back side also. any suggestions would be greatly appreciated. I did not know that there was a FDA warning about vivatrol at all. I was’nt told either.
Comment by Angela on 23 September 2009:
Hi,
Free4today they told me to rub it in to and hot and cold compresses. I kept on getting cellutis and had many antibiotics that did not help it and I was told to see a surgeon he did an ultrasound and had me in surgery the same day. When I came out he said it was necrotic and after 2 months I am still seeing him 2 times a week and I have an open wound still. The place that gave me the shot didn’t know about the FDA warning either. It is painful I think mine is finally getting better. I would print the fda warning and see a surgeon ask them to do an ultrasound and biopsy. I had to see many doctors and finally one listened.
Comment by Sherry on 22 February 2010:
I just had my first shot two weeks ago and have developed a tennis ball size lump at the injection site that is painful and has caused sleep issues relating to the discomfort, not to mention a constant reminder of the reason for hoping in the shot.
Comment by Gracie on 20 April 2010:
I have a friend that had the shot a month ago and also had a huge mass at injection site… treated with antibiotics… just had emergency surgery for necrotic tissue… this product should not be used. This is horrible!!! sounds like way too many surgeries to me.
Comment by christine on 19 July 2010:
I requested the medication after reading about it and had no information about the injection side effect. After my first the knot/lump developed and it has shrunk some, still about the size of a walnut. So, I got the second injection and the lump appeared sooner, more discomfort, yes – when trying to sleep – and I am trying hot then cold compress. No, redness. What prompts visit to surgeon? redness? discomfort? size? duration that lump exists? Pls help b/c I am growing more concerned. Thank you for sharing information.
Comment by Bryan on 3 August 2010:
I got my first shot 16 days ago and I have a lump about the size of a plumb at the injection site and it itches like hell. The Dr’s seemed totally unaware of possible complications. They just put me on antibiotics and seemed to think I was overreacting when I asked about possibly having surgery. I think I’m switching back to the daily pills.
Comment by kathy on 28 November 2010:
I received my 1st injection of Vivitrol on October 20, 2010. I saw my Doctor November 23rd and he advised me to go to the ER and they said I should see a surgeon in 1-2 days. I developed a site injection reaction that grew from a marble and is now this size of a hard, large egg. It has also changed color to a bluish color. I quit my job b/c I could not stand for 8 hrs or even sit for 8hrs much less do all the heavy lifitng without alot of pain. I was never told about this reaction by the Dr, nurse and the literature in the box does not reflect what the FDA demanded back in August 2008. Given informed patient consent, I would NEVER had done this and now may need surgery which I can’t afford. I also was never told the drug came in a pill form.
Comment by paula on 14 December 2010:
I have similiar lumps. Why do they continue to administer this medication?
Comment by Nicole on 21 December 2010:
I received my first shot in November 2010 and also developed a rock hard mass the size of a tennis ball, that I was told is normal and to use warm compresses and it would go away….it did not. Then I was told to go to the ER where they were unable to aspirate. Then I had it surgically removed and now I’m temporarily left with an extremely painful and uncomfortable opened wound . AND not to mention that I will have to be out of work with out pay indefinately and it is Christmas!!!! I agree with you all, that if I was told of this possible side effect……..I would never have had it.
Comment by Gerry on 22 December 2010:
I was administered the 1st shot of Vivitrol on 11/21/2010. I too experienced redness, itching, and a lump two weeks after at the injection site. Dr. prescribed a round of steroids. It is better, now it is almost Christmas, but the lump is still there and also disrupts sleeping. My question is, will the lump eventually go away? Does massage help?
Comment by Nicole on 24 December 2010:
Massaging can’t do any more damage, but I doubt it will go away without surgical intervention only because the hardness your feeling is most likely necrotic.And you can’t bring dead tissue back to life.
Comment by Tracie on 21 January 2011:
I had the shot on dec. 16, 2010. Large hard mass developed. I had to have surgery on Jan.17 2011. I now have an open wound that must be packed daily. I am needing to b out of work and this is expensive out of pocket, as well as painful! I am NOT happy about any of this! I never would have had this injection had I known of this increasingly occurring reaction. I have reported my experience to Vivitrol and the FDA.
Comment by Katherine on 8 June 2011:
HELP!! I have a HUGE lump that won’t go away. I can’t even wear the same clothes nor sleep on my back anymore; it hurts too much. Does anyone know what I can do or where I can go for help?
Comment by olinthia on 23 June 2011:
I got my first shot about 3 weeks ago and have now a hard bluish lump at injection sight that keeps growing. Now about the size of the palm of a small womans hand. I have called my doctors office twice they just keep saying its normal,it will go away.
Comment by chris on 14 August 2011:
I also had pain and a lump. One thing I have not heard from anyone else is that the pain was also accompanied with bloody stool. Had colon cancer scare, thank God that turned up negative. Anyone else seen any blood? A year later, I still have pain, not as sever. Also, my pain and lump were about an inch away from injection site. Anyone else? Location?
Comment by Jennifer on 16 August 2011:
I just had my first vivatrol shot a few days ago, and luckily no bump. A girl in my group session complained about the lump she received on her first shot, but she said it finally went away on its own after 3 months, but it indeed did go away eventually.
Comment by DFS on 16 October 2011:
I had one injection and 2 and 1/2 weeks later I discovered a hard lump about the size of a golf ball. Went to 4 doctors and no one knew what to do. Within 2 weeks it had grown to 5 1/2 inches by 5 inches and had to be surgically removed. This was 5 weeks ago and i have an 8 inch scar and no feeling in my hip.
Comment by Marissa on 13 December 2011:
I got my first shot on November 10th 2011. It is now December 13 and my lump is the size of a tennis ball its painful and itchy. I went to the doctor first she put me on antibiotics then the next visit a week later she took me off them and she pulled some fluid out to test it for infection….no infection she told me it was dead skin tissue. i am still having pain and its uncomfortable to sleep at night.
Comment by Jennifer on 18 December 2011:
I received my first shot just a little over a week ago and I have a lump about the size of a tennis ball where the medication was injected. It’s very painful! I haven’t seeked medical treatment because I thought I would do some research first before I went to the Dr.’s. I found this blog site and now this medication worries me. It’s in my best interest to recevie it, but if I’m going to keep getting a reaction like this every month, is it worth it?
Comment by Marissa on 29 December 2011:
I got my first shot November 10th 2011. I am still having problems with my injection site I have been to several doctors and been through it all . Its not a good thing my last doctor said that I have to have it surgically removed. I am not happy about this. If I would have known about this before the injection I would have never gotten it.
Comment by David on 27 February 2012:
It is concerning reading this. I’m 18 days into my first shot and it keeps hurting and getting more swollen. What should I do?
Comment by SJ on 13 May 2012:
I received the shot last year and had a terrible reaction that I am still recovering from. I would like to know how people are doing now. What has helped you recover from the shot? Have any of you fully recovered? Please email me at anonlump@ hotmail.com.