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LAWSUITS NEWS & LEGAL INFORMATION

Sandoz Recalls Methotrexate


Washington, DC: Sandoz Inc. announced today it has initiated a recall in the US of all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate Injection, USP product ("methotrexate") to the consumer/user level.

Sandoz is initiating this voluntary recall of all 24 lots of the affected product following the finding of small glass flakes by Sandoz quality control in a limited number of vials in four lots. The flakes are the result of delamination of the glass used to manufacture the vials of these two dosage presentations.

Due to particle size, there is the potential to develop adverse reactions in areas where the particles lodge. While it is unlikely, parenteral injection of drug from the affected lots could lead to serious adverse events, resulting in disability and death. Additionally, neurologic damage could result from intrathecal administration. Potential adverse events after intravenous administration include local damage to blood vessels in the lung, localized swelling, and granuloma formation. Intramuscular administration could result in foreign-body inflammatory response, with local pain, swelling and possible long term granuloma formation. Intra-arterial administration could result in damage to blood vessels in the distal extremities or organs. To date, Sandoz has not received any adverse event reports or product complaints attributable to particles from any lot of methotrexate, including the lots where flakes have been found.

Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis. The affected products are only the 50mg/2mL and 250mg/10mL presentations of methotrexate. For a complete list of affected product lot numbers, label type and expiration dates see the link below.

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Published on Oct-28-10


READER COMMENTS

Posted by

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My mom died instantly after developing a huge rash in her throat and mouth. She was admitted one day, couldn't talk, in intensive care the following day and die in intensive care.
Cause of death - Methotrexate toxicity Bone marrow

This was in 2005. She felt great, she had just stated taking it and boom - never spoke to me again after she was admitted to the ICU.

Her kidneys failed as well.

I had no idea the dangers of the drug and I am sure she was not ready to pass at age 64. She was enjoying her grand son way too much!

Reading these stories makes me sick. I should have followed up with cause of death.
Thanks for listening.
Tina

Posted by

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took mtx for ra for 6 or 7 months wife lost from 170 to 94 pds in 6 months this drug came out in 1948 for leukemia children patients said saved life but mind was gone. in 3 weeks after coming off 25 mg injection once week wife could not find bath room in house, thought she was joking, not! also had bad illusions so i got to studying the hell out of this poison, kills microndria cells in body so u get about one third of nutrients in digestive system, kills folic acid in cells which carry oxygen to all parts of body, causes all kind of cancer, causes (chemo brain) just punch in on lap top (dementia) kills 3 particular brain cells, causes causes bad illusions, used to kill fetus in unborn (had we know that never touched this damn poison its all about mighty dollar (hell with the dying) changes dna in your blood, take time to look all this up (truth n knowledge keep safe) all the drs and big pharma care about is the damn money period, wife like small child can hardly talk and have to attend to her like small baby, wicked society poison drugs. fast talkers making billions off lying to people..

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I went to the doctor for RA and was given methotrexate 1 time per week. I was referred by my new primary doctor after she did a set of test because of the RA. At the time of the referral my kidney function was in the 90 percentile. I was prescribed this medicine for 6 weeks. I went back after taking a blood test and was told to immediately quit taking it because my kidneys did not like the medication. I begin to have trouble holding urine. My primary sent me to a kidney doctor and at the time of his visit he told me I was having renal failure (22%)caused by the use of methotrexate and NSAID"s which NP told me I should continue to take until the methotrexate kicked in. Little did I know it was shutting y kidneys down. I am now on dialysis and had a massive heart attack leading to a quadruple bypass. I have had to quit my 60,0000 dollar and year job and on disability. Is there a lawyer out there that can help me. My life has been severely impacted by the prescribing of this very toxic medications. I even asked her why I was not getting medication for RA and she told me my insurance wanted me to take the methotrexate first. I need someone who can help me.

Posted by

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My mother was using this drug for years . She’s had tia s and memory loss . This drug was used for her eyes .

Posted by

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In Aug. of 2017, I was put on Methotrexate for RA. Had to switch from pill form to needle injections. On Aug. 13/2018 I was taken by ambulance to hospital with blood oxygen levels of 33 %. when I got to hospital they immediately started life saving treatment. The next morning I was intubated . I remained on life support for 4 days. I was diagnosed with Methotrexate Lung Toxicity. After, I was moved from ICU to the internal medicine floor for another 7 days. I was then allowed to return to my home town hospital to finish my recovery. After 10 days there I was allowed to go home. A couple of days of being home, the dr. that had prescribed the Methotrexate phoned me at home and told me that there was no way it was the Methotrexate. It was a long road to recovery with numerous trips to the city for CT scans, lung function tests and Ultra sounds. After a year I was cut back to lung function tests to once a year even though there was still evidence of scarring of the lungs. Towards the end of the first year I was seen by the prescribing dr. to see how I was doing. At that time she said "I guess it was the Methotrexate". My husband and I asked why we were never warned that this might happen. She asked if we were given any info. about the drug from her office in which we replied no. If I would have known that this was a risk I would not have taken it. I never took that medication again. Then in Nov. of 2019, I was having trouble breathing. My daughter took me to hospital. This was on a Monday. Dr. admitted me saying right lung was full of pneumonia. Started I.V. Wednesday morning I was ambulanced to the city. Once there, I was assessed and put into ICU. The next day I had to be intubated. Still wasn't responding well so they had to put me on my stomach for 16 hours. This allowed my blood oxygen to climb back up. After 16 hours on my stomach I was placed back onto my back. Slowly my levels started dropping again so after 8 hours on my back I was once again put on my stomach for another 16 hours. This time levels stayed up. Over the next couple of days they slowly began weening me off life support until I was able to breathe on my own. This was all told to me by my husband .I was diagnosed with bi-lateral pneumonia. Drs. said it was all due to the previous damage to my lungs by the Methotrexate. I've been home now for 2 weeks . Recovery is very slow. I'm scared to go outdoors in fear that I will get sick again. Drs. say to be very careful as the slightest cool breeze could get me sick again. So I don't know what the future holds. If there are any class action suits going on in Canada over this medication I would sure like to get on board. Using my husbands email address.

Posted by

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I stopped taking Methotrexate when muscle testing indicated it weakened my body. I have severe memory impairment and often forget that I met someone, even when I had long conversations with them. Methotrexate also caused a miscarriage. The only time I felt OK when taking Methotrexate was the day before my next dose. I can't believe I used to have to set aside an entire day just to feel terrible when taking this drug. I have found a significant amount of healing and improved all of my symptoms (moving from completely being bedridden, using a power wheelchair, and crippled by pain to working full-time and hiking, running, and dancing around) using herbs, diet, lifestyle, and Reiki. I am so glad I stopped taking this terrible medicine.

Posted by

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My husband was on this medicine many years ago for RA and starting having Kidneys issues..he then had a transplant and now has been diag. with cancer...mult. myeloma

Posted by

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My mother started taking methotrexate six years ago for her RA. This thanksgiving, her platelets dipped SO LOW that she suffered a subarachnoid hemorrhage and ended up in the ICU in Boston for 12 days, with a step-down unit stay for an additional three days. The first thing they did was stop her methotrexate. She’s been off it since and continues to improve but I almost lost my mom way too soon. This medication is poison.

Posted by

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My wife Hazel was given methotrexate for RA.She went from a healthy woman with some arthritis to a one hundred pound skeleton in twelve weeks.One dose per week.Her blood oxygen level was almost zero her lungs almost shut down.We were not advised of side effects of this lethal drug.Hospitalized for thirteen weeks at near death.Recovered enough to come home but no strength and needing oxygen all the time.I had to quit my job to look after her at home and suffered serious financial loss.Her prognosis was two to five years with pulmonary fibrosis.Hazel struggled for three years with no quality of life and passed away in August of 2015.Very sad. In Canada we cannot sue doctors only with great difficulty.Someone needs to start a class action suit against this horrible drug.!!!

Posted by

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I was diagnosed with methotrexate induced Hodgkin lymphoma

Posted by

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I was on this for a brief time to "test" for RA. But I have ended up with Kidney Cancer and currently having kidney functioning issues. Could the brief time I was exposed to this harmed my Kidneys?

I tend to react to meds fairly fast.

Posted by

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Hello, I was given Methotrexate and prednisone by a Rheumatologist. Last August I was having mouth ulcers and my left arm and index finger were enlarged so I went to urgent care. They did labs and came back and told me I was in kidney failure and that my blood count was depleted and immune system was very compromised. I was told by UC doctor that he was admitting me to the hospital. I went to the hospital and was admitted and it seemed as though they concentrated on my kidney failure. Meanwhile, my left arm and finger was still swollen. Rheumatologist came in and said my arm and finger was RA. I was in hospital 6 days and released but not arm and finger never really addressed. 4 days after being released I was taken back to hospital by ambulance due to running 106 temprature. Finally a infectious disease doctor came in and he took me to the OR for biopsy of chest wall on left side and a orthopedic doctor took biopsy of left index. Biopsy came back as fungal infection cocci which is valley fever. I knew I had valley fever in 2010 and so did all my doctors cause a chest biopsy had been done and it came back as valley fever scar tissue. So, the methotrexate and prednisone both immune suppressants were given to me caused the valley fever to rise in me, caused me kidney failure and since my body was depleted in immune system my body was not healing correctly. It took at least 12 weeks to heal chest wound and finger wound never healed and tendons were ruined and left index finger was amputated. Currently I have short term memory loss, dialysis for 12 hours a week, my legs are very week from being in hospital strapped to a bed for a total of 31 days and 4 different hospital I have to use a scooter or my walker. It is very sad. I am 55 years old and no longer can work and my wife has had to leave her job to take care of me.

Posted by

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Hi there... I noticed others were looking for a class action lawsuit for those patients whom took the oral pill of this horrible "big pharma" medication methotrexate. I just learned last night some devastating news...my step father was told he has 5-7years left to live due to the lung damage he has sustained from this poison. Is there a class action lawsuit? If so PLEASE let me know. My step father is a truly amazing man and treats my mom like a queen. I cant just stand by and watch him wither away.

Posted by

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My mother was on methotrexate pills since 2010 for RA, as time went on she started having memory loss, stroke like symptoms, shortness of breath, fatigue pretty much most of the severe side effects started coming about, she developed ulcers in her mouth, dark tarry bowel which led her to the emergency room and admitted to the hospital. Her organs had started shutting down, bone marrow wasn't produces her blood cells, she eventually died. Body could no longer fight infections, toxic, sepsis shock from the methotrexate...ended up on life support and later died. I file a report on fda/medwatch.

Posted by

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skateboardpro2001@msn.com. I was on methotextrate for about 2 months 8 polls every Sunday as directed when not working and still horrific pain I was switched to the injection of methotextrate did about4 till one day my husband heard me in my room gasping for air terribly he and my sister both ran in and seen I was in so much distress and rushed me to morton plant hosp where they rushed me back quickly and got me hooked up onto a ventilator which I ended up staying on for a week they tried taking me off in 4 days I quickly was going down and vastly hooked right back up! My husband was told by the doctor that the next 24 hours would be the most crucial as to what her situation and life would be like and he cried and my two boys bawling looking at their mom lifeless hooked up thinking they’d never see me again! Once they were able to get me off ventilator I was transferred to icu cause and don’t remember anything told my husband things I really thought was true! After close to month they try to do pt with me and I couldn’t stand legs and feet numb and swollen and still today due to neuropathy from the reaction to methotextrate! The doctor several doctors told me stay away from that pill it just about killed you I cried so scared and then said I’d never walk for atleast 3 years and never normally like before because of also suffering polyneuropathy! I could not feed myself as couldn’t lift right arm was very confused they said it would get better was meds but it hasn’t gotten better I still suffer with memory loss and is humiliating I’m only 54. This all happened to me may of last year and my life has been taken away from me I cannot walk good have to use a cane or walker I can’t enjoy my grandson cause my feet and legs will never be able to again my neurologist released me and said I’m sorry you will not be able to work again there’s nothing I can do for you except gabapentin which honestly really doesn’t do anything much he sai there’s no cure for neuropathy and I’m sorry you had to go thru this and end up with so many problems because of lethal reaction to methotextrate! I’ve walked on glass without knowing till saw blood and freaked looked down and it was me bleeding! I have no feeling from knees down broke my toe couple of times didn’t feel it when happened don’t even know how it happened! Fell down some steps at home even with cane feeling went numb in right foot missed a step fell down 2 step leg pinned under me my husband had to come help me I tried so hard to get it out myself but all I felt was numbness couldn’t tell if I was getting anywhere they took me hospital had fractured ankle had to wear a air boot! Most days I lay in bed with legs elevated cause when walking too much I can’t feel them at all! I also had lung problems to at hospital needed oxygen which I never did before! I am very forget ful memory problems which I never wanted to admit I will boil egg he comes finds no water left in pot babe u could of caught house on fire I’m sorry I forgot and he’d say and you think you can go back to work cause I want to but reality is I can’t I lost my income disability is less than what you make friends I talked to everything I also have become very depressed some days a lot of days sleep all day I’m always in pain and so sick of hurting and taking pills all over this methotextrate! I would like to sue for income loss and not being able to continue rising my retirement I lost about 490 a month having to go on disability and at end of this month I have no health insurance till June 30 2019 because for some reason I don’t understand you have to wait a year! We are struggling big time making bills paying doctors appointments and all my prescriptions and without insurance and looking at high costs they are I may not even be able to take some of mine which means my r a gets worse affects my immunity and I may end up dead! I want to sue for all the health problems this pill caused me and ability to not walk without a good gait almost like drunk and fall and at 54 loose my life! I wana sue because I have and can’t afford ins and embriel alone is 6000 a month for my r a and forteo 3000 for my osteo and if it wasn’t for being put on methotextrate then I’d be still working have insurance good income and still growing my retirement! Please help me recover my loss in a large cash compensation for loosing my walking good and long ability quality of life enjoying grandchildren and lung and needing oxygen at night and puffer during the day please by the grace on Jesus help me even doctors said methy tried to kill me stay away from it and ruin your lif and it has! Would you like having to sit in chair most of your life cause u hurt so much and feet and legs nerve damage all due to methotextrate I know you can help me sue for all these damages thank you hope to hear from you real soon I really need ins I can’t afford and reimbursed for all this huge pharmacy company caused to do to me and rob my life at young age I have a life and family to please have a heart and understand and I know u can win this case for me God shall help you!

Posted by

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My mom is a end stage 5 kidney failure patient, after one visit to a rheumatologist she was prescribed methotrexate for RA. She took one dose, 4 tablets at 2.5mg totaling to be 10mg dose. Two days later she began getting oral sores, a few days later her mouth was swelled shut with ulcers. She was brought to the hospital early on Friday May 4th, by May 7th she was brought to ICU, medically paralyzed with a breathing tube and sedated for 9 days. She is now off the breathing tube and out of ICU as of May 16th, however she now has memory loss due to other medications being used to combat the damage from Methotrexate. I intend to sue and am looking for someone to take my case.

Posted by

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I have Rheumatoid Arthritis and I have been on Methotrexate since 1993 and since then I have suffered from Chronic Hives and welps all over my body. The only thing that helps is Zyrtec and if I don't have Zyrtec I am basically covered with Hives and welps and I can't function. I also just suffered from a Pulmonary scare on March 26, 2018 called Diffuse Alveolar Damage Hemmorrhaging from the Lung.

Posted by

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Please give me lawsuit info on Methotrexate pill. I had horrific side effects from the Methotrexate. I am scarred in several areas of my body due to side effects.

Posted by

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My Dad took methotrexate for 10 years for his psoriatic arthritis along with leukovorin. His liver tests never showed anything alarming whole taking this toxic drug. About 4 years ago his doctor discontinued the methotrexate but kept him on leukovorin. In late 2016, my Dad was diagnosed with non-alcoholic cirrhosis of the liver. He never drank and this diagnosis was chalked up to the years of methotrexate! He then developed ascites where he needed a paracentesis (fluid draining) every 2-3 weeks.
This past month he deteriorated and fell last week. He had 2 blood clots in his leg, which went dead, requiring emergency surgery. The surgery advanced his cirrhosis and he died last night at age 76. Please get this drug off the market!!!

Posted by

on
My dad was given Methotrexate. He went from being a healthy independent man who took care of his loving wife of 60 years with dementia, to a man who was so weak he could not lift his arm, On Thanksgiving Day he was rushed to the hospital in respiratory distress and kidney failure. His lungs were so damaged and the only thing they found was that he had methotrexate poisoning. Dad never recovered and eventually subcomed to his damaged lungs and kidneys. My dad died on December 21, 2017, leaving behind a widow who was so traumatized by witnessing him go into respiratory arrest three times, that she is now in psychosis state in the hospital.

This is a horrible medicine that has taken away my dad, a husband and a caretaker. I want something done to prevent further destruction to other families
Please give me information on how we can also get on a class cation Lawsuit case

Posted by

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I was treated with Methotrexate for RA and within six months had developed Pulmonary Fibrosis. I can no longer work as a Phlebotomist due to chronic fatiigue and breathlessness. I wear oxygen when walking more than short distances and for sleeping at night. This drug ruined my life.
I am searching for Class Action to participate in.
Thank you in advance for any information you may offer.

Posted by

on
I also am curious about lawsuits with the pill form of methotrexate.
My husband was on it for around 2 years and now suffers from pulmonary fibrosis.
The specialist says it's RA induced, but he had NO lung problems before taking this medicine.
He now is on oxygen and has not been given much hope.
Thank you for your time given,
Erin

Posted by

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I would like to know if on!y being g given affected vials of methotrexate are included. I had been prescribed methorexate and had to be discontinued to to serious issues and now i require oxygen while I sleep. Is there a class action suit, or just for certain vials? P!ease advise. Thanks

Posted by

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I have been taking Methotrexate for years, have lost most of my teeth, also have 13 falls since September 2016. Since I do not have dental insurance, it has cost me plenty out of pocket. Wish I had known this earlier. Do the doctors not know about this, my dentist and surgeon does.

Posted by

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I have had psoriasis/psoriatic arthritis/rheumatoid arthritis for over 40 years. I am a 55 year old female on disability diagnosed with autoimmune cirrhosis of the liver due to using Methotrexate. I was hospitalized with altered mental status not knowing who I was. After many tests, I was diagnosed with the autoimmune cirrhosis of the liver. The first thing the doctors did while I was in the hospital, was to take me off of Methotrexate and told me to never take this medication again. After a liver biopsy, several endoscopes, CT scan, MRI, and multiple lab tests, I had a definite diagnosis. My outlook definitely includes many more tests and seeing multiple doctors. The expense is very difficult to contain. I tell others that have arthritis to be aware of the high risks of taking Methotrexate. I wish someone had told me.

Posted by

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My wife has had RA for 20 plus years, and has been taking methotrexate for 17 years on and off. over the last few months there has been a complete change in her behavior , it started with extreme fatigue. And went as far as shutting everyone around her out. Within the last 3 weeks shaking of the hands and legs started to aquir . Then slurred speach and memory lose.. After A MRI, MRA and spinal tap a white fog was discovered all over her brain, the neurologist said he had seen this before with methotrexate users but never this amount of fog. He informed us that steroids and antibiotics were the only chance to clear this up, but with this treatment there were no guarantees and there was a chance that the damage would be non reversible. We have spent the past four days in the hospital getting treatment. Luckily today we have seen a improvement of what I would say 50%. . imo the doctors that give this $&it to people should be thrown in jail, especially when they know this can destroy the brain. There is a treatment for RA that we have used before and it is used around the world except here in America called DMSO, it is a two day infusion my wife had it done 12 years ago and for over a year her reaction to it was the best, no stiffness or pain in the joints , no need for pain meds or steroids. For that year she was the happiest I have ever seen her (before the dmso, she had 2 hip replacements , 2 knee replacements and one shoulder replacement all before the age of 30! FDa says there is no proof that dmso works only because there is no profit in curing people. We would have continued traveling to get this treatment but we decided to start a family. She received the treatment in Mexico and since the birth of our children what has happened with that country with the cartel we can no longer risk going there.. As I stated above dmso is available in other country's and from this day on I will save every dollar I can to make sure I can fly her somewhere, where she can get a treatment that works without the side affects of brain damage, liver damage ect... This wasn't ment to be a plug for dmso but to let everyone know the methotrexate has crazy side affects that could have taken my wife and the mother to my very young children.. Of course this is all my opinion so hopefully these quack drug makers along with the fda and so called doctors can't try to sue me for bashing there evil ways . I hope this little ramble at 230am helps someone before this happenes to them or a loved one

Posted by

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I took .8 injection of methotrexate for almost 2 years for lupus sle and rheumatoid arthritis. I have permanent memory loss, and knumbness in my back , legs and feet. I still deal with confusion.

Posted by

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I was given the methotrexate for arthritis. It caused me to loose my significant vision. Had better than 20/20 my entire life till I took this medication over a couple of month period. Also was and still feel like it affected my mechanical skills. I wasnt able to comprehend simple technical publications that I've always been able to do before. On top of just feeling weak and unable to perform all of the simple tasks that I have always done.

Posted by

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I was seeing a MD I had one ace on my right shin ask him about it he said it look like skin cancer. He got an appointment with Dr N. Went in he gave me a shot that made the place puff up then he drew out some fluid went to lab came back and said at least it is not melanoma He put me on Methotrexate 2.5 once a week. I took this along with other meds:naproxen500mg 2a day Hydrochlothiazide25mg 1a day Gabapentin 600mg 3a day. I lost my strength I could not walk I lost my memory I am slowly remembering and walking slowly these meds caused my face to swell and my eyes were shut the left side was so hot it blistered I was taken to urgent care by my husband I don't remember this trip. I am still affected on both legs and feet top and bottom I hope you can help me.

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