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LAWSUITS NEWS & LEGAL INFORMATION

FDA Warns of Serious Adverse Reactions to Naltrexone


Injection Site Reactions Reported in 196 Patients

FDA is notifying healthcare professionals of the risk of adverse injection site reactions in patients receiving naltrexone (Vivitrol). FDA has received 196 reports of injection site reactions including cellulitis, induration, hematoma, abscess, sterile abscess, and necrosis. Sixteen patients required surgical intervention ranging from incision and drainage in the cases of abscesses to extensive surgical debridement in the cases that resulted in tissue necrosis.

Naltrexone is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment. Naltrexone is administered as an intramuscular (IM) gluteal injection.

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Published on Aug-12-08


READER COMMENTS

Posted by

on
I've been on and off the shot for goin over 6 yrs. My lower back gives me problems all the time, where they gave me the shot. I can't take any medication to help because its blocked everything. Its completely ruined everything I used to enjoy. I try to put 40 hrs in a week but its hard

Posted by

on
I received the Vivitrol injection on 1/20/23 from Lumiere healing centers in west Chester Ohio administered by Leigh Boxie. I have been told it was not administered correctly and have seen several doctors as a result. I got cellulitis and was out on multiple antibiotics. I have several doctor notes stating this was a result of the injection being administered subcutaneously and not intramuscularly (FDA advises how dangerous this is). I also have necrosis at the injection site and a wound the size of a baseball. The injection cost me almost 500 dollars and none of the medicine went into my system. I was told it will take 6 months to heal and am in pain daily from it. I lost my health insurance but have had to go back to wound care. On 5/5/23 I got surgery to excise the dead tissue (almost to the muscle) and then surgery again 5/25/23 to close it. Much like others, Lumiere pushed this on me, did not explain side effects, lied in my medical records (once I threatened a lawyer) and blamed me for all the issues I have had since.

Posted by

on
I been on suboxne vivitrol su lacase and I haven’t been the same since 2019 due to prescribe medication how can your law firm can help me sue these company doing test on us like we are some lab stunt dummies we are human and all these things get us depressed anxious change of mood and the list goes on and the saddest part is my mental and emotional wich how does the fda aprove such bad medication to Al of us with dependency thanks please reach asap

Posted by

on
My son's girlfriend recieved the shot. 10 days later she rode a 4 wheeler & it broke down on her not far from the house. She pushed it back home, went inside, & complained of mild chest pain. Less than a minute later her eyes rolled back in her head & she stopped breathing. He did CPR for 30 minutes to no avail. She was a strong 37 yr. old woman. I don't know many women who could chop wood, but she could chop more than some men I know. My son read a warning online after that not to over exert yourself while taking the shot. I've read so much that I am appalled that it's even considered a safe treatment. Let alone the cost of the shot being $1550.00 compared to the oral medication of the same drug being $26.00 & the oral would be safer in the case of the need for an emergency surgery. Unexpected car wrecks, gall bladder surgeries & appendectomies do happen. As does Covid 19. It warns not to take cold, cough or diarrhea medication while taking the shot or within 7 to 14 days of starting it, due to it can cause sever opiate withdrawal syndrome. Some have died of sever opiate withdrawal syndrome. How is this considered safe at all? I've been asked by her Mother who is in hospice with cancer, to look into legal action & gather all of Brandi's medical information pertaining to the shot & whatever else would be needed to put a case together. Brandi leaves behind a handicapped, minor son & 18 yr. old daughter. Please contact me & let me know if she might be included in your class action lawsuit.

Posted by

on
I attended the most expensive and so called world renowned in patient mental health facility. They strongly suggested and pushed that I take Vivitrol for alcohol use disorder. Based on information and belief, the Rehab facility had a contract with Vivitrol and the facility received free samples of Vivitrol and other benefits not disclosed to the patients. I was never warned of the side effects. I subsequently developed an acute allergic pneumonia reaction to the medication, which was supported by chest x rays. Much to impact here, but email me if there is something I should send to the FDA.

Posted by

on
I got that vivitrol shot and now I have a very hard painful lump where in my hip where they gave me the shit.i cannot lay on that side at all and when I lay on the other side it feels like something is pulling from the side I got the shot on..it's very painful to push on it..I don't know what to do and I thought it would go away but it never did..I'm scared it might be one of the bad effects that you guys are talking about and that it will later on down the road be dangerous to my health,it's only getting worse.please help me if you can.

Posted by

on
I pray you're reading these posts because my husband needs your help desperately. He's laying in the hospital right now as of, 12/20/21, with failing kidneys, liver and heart damage and a blood clot in his lung. He has scratched his back so much due to severe itching, that he's caused himself to bleed. Now my husband is on dialysis three times a week. The hospital won't release him until they find a facility to place him to receive dialysis.

Anthony Bryant began taking injections to curve his desire for alcohol during early 2021. He's never had any of the above problems before vivitrol injections. He did suffer from high blood pressure and depression.

Please include my husband in your class action suit and WIN on his behalf.

Helen Head

Posted by

on
I voluntarily wanted to use it. I eneded up with huge pockets of fluid at injection sites. Weird scaring at injection Horriable back issues ensues. I spoke with a dr who said early trials had all these issues especially in women i only did three shots.

Posted by

on
I was given the ultimatum either go to prison Get the vivitrol shot
I’m scared to sue I’m in Dui court My Dui is 5 years old I had to get the shot or I would not be Released from jail it was mandatory now I have a golf ball size not on my top but area it’s been 10 days knot only get bigger and bruised it hurts so bad idk what to do next I don’t wanna got to jail and I can’t afford attorney after I got the shot I wasn’t given no information or before I got the shot I wasn’t giving any information on the shot and side effects

Posted by

on
My son had shot of vivitrol and shot himself in the head the next day he was 31 his name is Christopher if anyone knows of attorneys handling these cases please email me

Posted by

on
Long story but my son is being forced to take the injections although the first time he received it he was very very sick and suicidal He has suffered from chronic depression since he was a kid. His opiode addiction began after some surgeries and of course his surgeon just kept writing the prescription. The justice system has used him to prove their controlled make an example out of him. I was even told this by a Commonwealth Attorney who told us that after we filed a complaint against his probation officer and I contacted the Attorney Generals office -- the local system hates us now and would do anything to bury my son to get back at us for the complaints etc. I backed off from pursuing anything out of fear - they were threatening to put my son in prison for 5 years - he only had one charge on his record a non-violent possession charge. We have been going thru hell for over 5 years now and he will never get out of this system. I am a single Mom and cancer survivor of 7 times and now raising my sons two children like so many other grandparents. I have been to every court hearing and I have listened to other hearings and seen what has been done to others - even the Judge admitted in court that there are many inconsistencies in her court room. It is sad and they have such control of the lives of addicts. No non-violent addict belongs in jail. The DOC rehab programs are in the worst parts of town and they release them way to soon and shove them out on the streets. It is like they are setting them up for failure. Part of their program is to make addicts sit in front of a wall facing the wall for about two hours then they have to sit and write about what they thought about. ARE YOU SERIOUS! I had my son in a faith based program where he was making tremendous progress - he had a few setbacks but over all was making progress. His PO at the time would never return calls from the rehab use worker and they had other addicts there that were on probation so we knew the program was accepted by the Commonwealth. Our PO would to cooperate and even would not assign a PO in that County to supervise my son. The rehab center kept in touch with me and even said themselves that they had never seen anything like it. They even went as far as to state the my sons civil rights were being violated by the probation office in Oldham County. They also stated that it was obvious that they did not want him in the program there that they were setting things up to get him back in a DOC - so the Commonwealth could make their money and also that PO office could control everything. They did pull him out of that program claiming that it did not comply with their requirements - which was a lie. This is only part of the shady and unbelievable system we have been fighting with here. When I contacted the Attorney Generals Office they were more than supportive and read a letter my son wrote. They wanted us to put more info down in writing and name names so they could investigate. We are terrified to do this with them still having control of our lives. But something has to stop this. My son is holding down a great job and is in church with me and his children. He is trying to get his life back but the system is not going to let this happen. He needs to be on medication for his depression but they keep stalling an appointment with a psychiatrist saying he can be seen until February. I feel they want to start him on these injections and stall him getting on meds and of course the holidays can be depressing for some. So there is a good chance he will relapse or become suicidal and something is going to happen. The system hs a system for keeping addicts in the system and in their control - it is a money making business! The system beats down the addict until they break and relapse or walk away from the program and then they end up doing time. I sat in a courtroom and listened to a young man get sentenced to 10 years in prison for walking away from a DOC. Hi mother was sitting beside me sobbing and my heart broke as this is just sick and as I always say it is criminal! It is sick and criminal what is happening to non-violent offenders and something has to be done. The truth must come out! The justice system is working with the pharmaceutical companies to keep addicts in the system and making both pharma and local systems rolling in the dough. My son has done over 250 days in jail over the last 5 years - some for probation violations and non of which were violent events. He has been in and out of rehab. Some of his time has been for using kratum - which is a legal substance but one of which does actually help chronic pain and depression but here is being treated as if it were heroin. Yes it can be abused just as cigarettes and anything. However it is a legal substance! The programs they require him to attend tell him they realize he needs something to help with his depression then they put him back in jail for using kratum which does really help his depression. He has an awesome job now and his job is very proud of his work and have given him a raise after just a short time. But now - trying to do work release costs $20.00 a day - and the Drug Court Program is forcing him to start these injections and the way he reacted to the injection before I fear he will lose his good job which will push him over the edge. I have been in social services for over 20 years and going thru this with my son and experiencing the justice system and how they treat and manipulate the lives of drug addicts instead of helping save them .... I have no respect for the judicial system anymore. It is criminal how they have turned an epidemic of drugs into a billion dollar business. Kinda like everyone knows what can heal and prevent cancers but it will never be told because they have turned that into a billion dollar business as well. This reminds me of Hitler and Nazi Germany when they used Jews to do medical tests and do research and use them as guinee pigs this is what our Justice System is doing with non-violent offenders and drug addicts across this Country. This drug has horrible side effects - my son has experienced them - if he says no to it they will revoke his participation in Drug Court and throw him in jail. Our story has to be told it has to be heard. Someone out there has got to get mad along with me and help fight for our addicts and stop the criminal treatment by the judicial system. If anything happens to my son after having these injections or if he is so sick he loses his job - the shit is gonna hit the fan and my voice will be heard across the Nation!

Posted by

on
I had 4 shots of vivatrol. With each one I have had terrible
Itching god awful on my arms broke out with small
Pusey bumps the 4th shot I ended up in the hospital
With dangerously high white blood count and very high
Eosinophils 5 bags of antibiotics and fluids. I was in the
Hosp for a week. Still going to drs to figure this out 10day
Later.

Posted by

on
I get painful lumps after vivitrol injection. Is this dangerous and what do I do

Posted by

on
I received my vivitro injection and 3 days later ended up admitted to the hospital for not being able to breathe and for heart palpitations. I developed an allergic pneumonia with severe effects. I was hospitalized for 4 days.

Posted by

on
Ive recieve injections since june 2018.the. pain ive been in since june has scared the hell out of me.ive continue to get my injections on my right side of my buttocks because the left side been hurting since the first shot. I stop getting ny injections since Nov 20 2018. Because i think somethings wrong with my left side. Ive been clean since June 13 2018. Im holding on for dear life cus i dont want to take any pain medication because of my addiction to drugs. Just wanted to tell someone what ive been going threw since my first injection.

Posted by

on
I got vivitrol shot and had three seizures that night and ongoing nightmares i still suffer from related to those seizures

Posted by

on
I take naltrexone tablets and it seems it has made my depression worse i don't enjoy drinking any more or even have a urge to but i feel no more pleasure in the little things

Posted by

on
It's more poison and ruined my life to degree doctors seem to prefer patients that die instead of come back to speak about how bad the sysmtoms are.

Posted by

on
I have great pain in all my joints and muscles when I get my injection. Plus my butt hurts for a week or more.

Posted by

on
I just got home from the hospital today, I spent a week there due to a first time vivtrol injection. I suffered rapid rhabdomyolysis and some necrosis. I feel I am owed something for pain and suffering as well and rehabilitation.

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