Methotrexate Medication Errors Resulting In Injuries, Deaths: Report

A new report warns about the risk of medication errors with methotrexate-based drugs, such as Trexall and Rheumatrex, which can result in serious adverse health effects, including death.

In the Institute for Safe Medication Practices (ISMP)’s QuarterWatch (PDF) report release this month, researchers indicate there have been a number of adverse events submitted to the FDA where patients accidentally took the drug daily instead of weekly, resulting in severe injury or death, including at least five patient deaths over an 18-month period.

Methotrexate has been on the market for decades. It was first approved by the FDA in 1953, and is used to treat various forms of cancer, as well as rheumatoid arthritis and psoriasis. However, it is considered highly toxic.

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ISMP researchers found that use of methotrexate has increased significantly in recent years. They estimate that the number of patients on the various forms of the drug doubled from just over 500,000 in 2013 to more than 1 million in 2017.

The report notes that problems with methotrexate stem from the wide range of dosages and durations of treatment, leading to patient confusion about when they should take the drug.

“Put simply, a medication error in frequency of taking a tablet can cause severe harm or death,” the researchers warned. “For rheumatoid arthritis and psoriasis, it is taken once weekly. For some oncology indications, much larger doses are administered daily for several days, often with treatment interruptions to allow recovery.”

The report notes that the weekly doses can be even more confusing because they are sometimes given as three smaller divided doses over the course of 12 hours.

Patients who are prescribed the drug weekly and accidentally take it daily face painful and extensive skin damage, suppression of blood cells, liver damage and death. Researchers found that the FDA received five reports of patient deaths specifically due to dosing confusion in the 18 months before June 30, 2019. It also received nine reports of patient hospitalizations due to the same problem.

The researchers found that in six cases, the error was made by the patients, most of whom are older. In eight cases the drug was given to patients incorrectly, either at nursing homes or through pharmacies.

The report also warns that many incidents likely go unreported, and that there were more than 1,800 reports of injuries linked to the medication, which in some cases involved toxic injuries at normal doses.

“In a modern protected society, we should not provide medications that can cause potentially fatal errors affecting up to 1 million people without adequate safety precautions in place,” ISMP researchers warn. “Further, we estimate the methotrexate error risk is getting worse rather than better. As noted, patient use nearly doubled in just four years, exposing many more patients to the risk.”

40 Comments

  • Rebecca zunigaMay 18, 2022 at 5:32 am

    My mom has been taking this drug For awhile For her rheumatoid artritis and she ended up in The er not being able to walk and she has what they Call anemia grave it has her getting blood transfusiones and they Say there is no cure SO she goes now going on 4 times and gets her stomache glued up From The inside and she swells up SO Bad My mom Was a normal mom now We have to worry about when it don'[Show More]My mom has been taking this drug For awhile For her rheumatoid artritis and she ended up in The er not being able to walk and she has what they Call anemia grave it has her getting blood transfusiones and they Say there is no cure SO she goes now going on 4 times and gets her stomache glued up From The inside and she swells up SO Bad My mom Was a normal mom now We have to worry about when it don't work and might be without a mom all because of this drug how is that fare if theuy don't find a cure thats wat Will eventially happen this is bullshit .She is 74 and like i said she Was a in good Health before this

  • eddieApril 18, 2022 at 8:15 pm

    My life has been totally destroyed by Mexatrexate toxicity. I can't walk one city block, I can't mow my lawn, I no longer maintain my cars, etc, etc. Finally, my prescribing doc didn't follow-up with my usage at all.

  • KarieMarch 29, 2022 at 3:43 pm

    My daughter died 12/19/21 talked to coroner this morning-waiting on more tests / report from pathologist for her liver -methotrexate was most likely to blame RA use. 33years old and 1 of triplets .!!

  • AngelaMarch 14, 2022 at 4:00 am

    I was on methotrexate for 10 months . My dosage was 2.5 6 tablets every week, then my doctor increased to 8 tablets every week. I did not want this and I wanted to try a new medication . Couple months later contracted Covid -19 , blood clot to lung and the worst bad mouth sores. ( ulcers all down my throat ) The hospital blame this all on the drug of methotrexate. Please sign me up for the [Show More]I was on methotrexate for 10 months . My dosage was 2.5 6 tablets every week, then my doctor increased to 8 tablets every week. I did not want this and I wanted to try a new medication . Couple months later contracted Covid -19 , blood clot to lung and the worst bad mouth sores. ( ulcers all down my throat ) The hospital blame this all on the drug of methotrexate. Please sign me up for the class action suit !!!

  • PennyMarch 13, 2022 at 7:02 pm

    My husband was prescribed Methotrexate when he first started with Rheumatoid Arthritis. Soon after taking it he developed Pulmonary Fibrosis. Now he is on 24x7 oxygen with no cure. NOW he find out it was probably the Methotrexate!!! But what can we do now. You trust doctors. No one ever told us if this high risk. He now takes an Enbrel shot every week for the arthritis. It has been a miracle f[Show More]My husband was prescribed Methotrexate when he first started with Rheumatoid Arthritis. Soon after taking it he developed Pulmonary Fibrosis. Now he is on 24x7 oxygen with no cure. NOW he find out it was probably the Methotrexate!!! But what can we do now. You trust doctors. No one ever told us if this high risk. He now takes an Enbrel shot every week for the arthritis. It has been a miracle for him.

  • JamesFebruary 22, 2022 at 12:23 pm

    My wife, stage 4 breast cancer metastasis to bone, lymph, cerebral spinal fluid... Is told that the only options left are injections into the spinal fluid of this methotrexate.... She goes along with it.... Less than 18hrs after she seizures and now is on anti-seizure meds with a prognosis of days maybe weeks to live. I read the MSDS and it says not to inject into intrathecal (spine) with any[Show More]My wife, stage 4 breast cancer metastasis to bone, lymph, cerebral spinal fluid... Is told that the only options left are injections into the spinal fluid of this methotrexate.... She goes along with it.... Less than 18hrs after she seizures and now is on anti-seizure meds with a prognosis of days maybe weeks to live. I read the MSDS and it says not to inject into intrathecal (spine) with any preservative....I have a picture of the bag it came in ....says "sodium chloride 0.9%".....after the seizure I'm curious looking up the MSDS on this drug and says all caps....DO NOT INJECT INTO INTERTHECAL WITH A PRESERVATIVE......excuse me?? DO I have a case? She's bloated stomach and legs edema 2-3x since and seizures if we don't keep her meds regular. They say we have days maybe weeks....

  • GretaJanuary 10, 2022 at 12:22 am

    My husband of 38 years was prescribed Methotrexate for an autoimmune skin rash called Lichen Planus. He had been on this med for a few years. He developed the Herpes virus in his mouth and throat and had a platelet count of 15. These are side effects of Methotrexate. He also lost lots of hair and had kidney problems. His mouth was so sore he was unable to eat and I called the rescue squad. He was[Show More]My husband of 38 years was prescribed Methotrexate for an autoimmune skin rash called Lichen Planus. He had been on this med for a few years. He developed the Herpes virus in his mouth and throat and had a platelet count of 15. These are side effects of Methotrexate. He also lost lots of hair and had kidney problems. His mouth was so sore he was unable to eat and I called the rescue squad. He was in the hospital for exactly two weeks. After a week in the hospital, he was unable to talk and they feed him by IV. He hemorrhaged to death and died on December 2, 2021. I am heartbroken over this horrible drug. These side effects were awful and he died in pain.

  • StanleyDecember 17, 2021 at 5:53 pm

    My mother was misdiagnosed for Rheumatoid Arthritis when she in fact did not have it. She was prescribed Methotrexate and used it for 1 month. A few months later she had fatty liver disease which manifested into Adenocarcinoma Pancreatic cancer in a span of 3 years. She is now in stage 4 pancreatic cancer and her cancer doctors attribute it to Methotrexate.

  • AnnetteNovember 6, 2021 at 8:24 am

    I am in bad shape from taking methotrexate. I have doctor and hospital bills. I have rheumatoid arthritis for which I was prescribed methotrexate. I took it for about 5 yrs daily. I have hemmoraging from my ileostomy, several taking me to ER. My arthritis doctor says it’s from the methotrexate. I had skin cancer on my face. I will soon have to go in for TIPS procedure as my liver is not working an[Show More]I am in bad shape from taking methotrexate. I have doctor and hospital bills. I have rheumatoid arthritis for which I was prescribed methotrexate. I took it for about 5 yrs daily. I have hemmoraging from my ileostomy, several taking me to ER. My arthritis doctor says it’s from the methotrexate. I had skin cancer on my face. I will soon have to go in for TIPS procedure as my liver is not working and producing varies which causes bleeders.

  • Anabel VOctober 19, 2021 at 2:16 am

    I've been taking methotrexate for 12 years. I had two heart attacks with a full cabbage done. I also have kidney disease and liver disease. Multiple problems. This medication effects our organs. I was diagnosed with sarcadosis in the lungs and it is beyond me why I was prescribed a med they give to cancer patients.

  • FallonOctober 8, 2021 at 3:19 am

    They injected me twice with methotrexate because I had a etopic pregnancy so the used it to kill the baby that was growing in my tube now my inside is always in pain where the baby was located.What can I do ?

  • JanetOctober 4, 2021 at 6:03 am

    I developed sores in my mouth and still have finger swelling been on methoxate for a while excema and ra

  • hulaliAugust 30, 2021 at 6:37 am

    My mother in law just passed august 8th, doctors said it was the methotrexate that lead to multiple organ failure and eventually death- she thought it was helping but it killed her

  • DerrickAugust 4, 2021 at 9:35 pm

    My mother, Nancy, was put on Methotrexate around 2010 for severe Rheumatoid Arthritis and after many years of refills by her physician she was taken off in early 2021 because of damage and scarring of her lungs. This had a direct effect on her ability to breathe with little to no physical activity. My mom was only 74 years old and active. She was reduced to using a inhaler daily and after catchin[Show More]My mother, Nancy, was put on Methotrexate around 2010 for severe Rheumatoid Arthritis and after many years of refills by her physician she was taken off in early 2021 because of damage and scarring of her lungs. This had a direct effect on her ability to breathe with little to no physical activity. My mom was only 74 years old and active. She was reduced to using a inhaler daily and after catching pneumatic in June she fought but was unable to get through the infection because of her weakened state and died on a ventilator on July 2, 2021. Her 4 sons weren't even able to say goodbye.

  • SusanJuly 2, 2021 at 9:25 am

    I was prescribed methotrexate for eight years to be taken everyday. I developed sores in my mouth and was eventually taken off all my medications. I was told, after I healed, that I almost died from it. I was also told I could never take NSAIDs again. It has made my life difficult and painful.

  • JoannaJune 29, 2021 at 8:50 pm

    I believe that methotrexate has destroyed my lungs I have two different kinds of lung cancer going on massive nodules on the lung didn't have any lung problems until after being put on Methotrexate for my serio positive rheumatoid arthritis. I would like to join in a class action against the pharmaceutical company that makes methotrexate they should not be allowed to give people toxic medication

  • CherylMay 15, 2021 at 11:48 pm

    My wife of thirty years was put on Methotrexate for eczema. She took 4 doses of 10 mg once a week for one month. It destroyed her lungs and she passed away. Every doctor told us they have never heard of this fatal side effect killing someone after such a short period. Well wake up doctors I here to say it happen. My wife was in perfect health with no other underlining health issues. She was never [Show More]My wife of thirty years was put on Methotrexate for eczema. She took 4 doses of 10 mg once a week for one month. It destroyed her lungs and she passed away. Every doctor told us they have never heard of this fatal side effect killing someone after such a short period. Well wake up doctors I here to say it happen. My wife was in perfect health with no other underlining health issues. She was never warned about this horrible drug destroying her lungs in one month.BUT IT DID. I live in a state where if you try to sue the doctor for malpractice or negligence you have one year from date of death. It took nine months for her hospitalization medical records to be reviewed by two other doctors. Needless to say I never was able to go forward with it. Why isn’t there a class action suit being filed on behalf of all her have had this drug destroy their life as well as the trauma love ones are left with every day. My recommendation would be get as far away from this drug as possible or it will destroy your last fe as you know it.

  • LawrenceApril 23, 2021 at 8:12 pm

    After taking methotrexate from January 2021 to August 2021 I was diagnosed as having cancer of the jaw. On August 24 I had 12 hours of surgery where the doctor removed my jaw and all my lower teeth except 2. Also, all my lymph nodes around my neck, a bone in my right leg to build a new jaw, and a vein. I had 30 radiation treatments and 4 chemo treatments. I will have CT scans for the rest of my li[Show More]After taking methotrexate from January 2021 to August 2021 I was diagnosed as having cancer of the jaw. On August 24 I had 12 hours of surgery where the doctor removed my jaw and all my lower teeth except 2. Also, all my lymph nodes around my neck, a bone in my right leg to build a new jaw, and a vein. I had 30 radiation treatments and 4 chemo treatments. I will have CT scans for the rest of my life, I am seeing my surgeon every 3 months. I have to see my dentist every 4 months for the rest of my life and I do not have dental insurance. Right now I am cancer free by the grace of GOD. I am 75 years old and I will NEVER go through this again.

  • ChristineApril 19, 2021 at 3:33 am

    My mother died in 2017 due to methotrexate poisoning. It was prescribed for eczema. She fell ill and went to the ER where she was found to have pancytopenia (low count of all blood cells). She developed pneumonia and then discovered she had interstitial lung disease from methotrexate use. This was confirmed by autopsy. She could not recover from the pneumonia given the low blood counts and lung[Show More]My mother died in 2017 due to methotrexate poisoning. It was prescribed for eczema. She fell ill and went to the ER where she was found to have pancytopenia (low count of all blood cells). She developed pneumonia and then discovered she had interstitial lung disease from methotrexate use. This was confirmed by autopsy. She could not recover from the pneumonia given the low blood counts and lung damage, both due to methotrexate. Please contact me if there is a class action lawsuit against methotrexate manufacturer.

  • SeanApril 14, 2021 at 4:22 pm

    I have been taking that road tracks same for 10 years and warmed up getting leukemia from it

  • DawnMarch 30, 2021 at 4:36 pm

    My Uncle died of ALM January 2021 which was caused by Methotrexate that was prescribed to him.

  • JacquelineMarch 19, 2021 at 8:27 am

    Today I had to admit my mother to the ER after she had months of stomach pains and sores started to develop in her mouth to where she couldn’t even eat. She recently noticed blood in her urine so we went to get a blood test and the next morning they call at 6:45am to tell her to go straight to the ER and get more blood work. They ended up admitting her and called To tell me methotrexate was the ca[Show More]Today I had to admit my mother to the ER after she had months of stomach pains and sores started to develop in her mouth to where she couldn’t even eat. She recently noticed blood in her urine so we went to get a blood test and the next morning they call at 6:45am to tell her to go straight to the ER and get more blood work. They ended up admitting her and called To tell me methotrexate was the cause of all of this(the stomach pain they are calling colonitis and also methotrexate toxicity ) from the medicine that was supposed to help her. She is now still in the hospital while they are trying to reverse the infection that was caused by this medicine that was supposed to help her. It’s all a racket the pharmaceutical companies put you on medicine so you can be dependent to 10 more it doesn't make any sense to me that these drugs companies are allowed to put a TOXIC medicine on the market knowing that it causes these horrible problems for the patient. Please contact me to be included in the action suit. I can’t imagine how high our hospital bill will be for this.

  • AnnMarch 3, 2021 at 4:07 am

    My mother was on methotrexate and had ALL the side effects when she passed. She was so miserable with the mouth ulcers on top of everything else. She was on it for rheumatoid arthritis. She took it correctly because I was the one who oversaw her meds. This drug is dangerous. Class active n lawsuit? Count me in.

  • TedFebruary 13, 2021 at 2:08 am

    My wife died from this stuff she was never told the side effects we were married 41 years here liver kidney Cole en now all I have is her memory she cry every day for 5 years know dr would help her now I wish I can be with her she was my best friend I miss her y did thay give her that drug I don't like doctors any more seniors are doctors pot of gold some one should wa[Show More]My wife died from this stuff she was never told the side effects we were married 41 years here liver kidney Cole en now all I have is her memory she cry every day for 5 years know dr would help her now I wish I can be with her she was my best friend I miss her y did thay give her that drug I don't like doctors any more seniors are doctors pot of gold some one should watch them

  • ShirleyJanuary 22, 2021 at 5:03 pm

    My husband died of complications from stage 4 liver disease due to a 10 year course of Methotrexate.

  • MelissaDecember 1, 2020 at 1:47 pm

    Horrible drug!!!!! My father was diagnosed with RA when he was 29 & died in 2010 at the age off 69. Death result: Lung disease caused by over exposure from Methotrexate. I remember my dad using this horrible medication back in the 80s. It is very tragic that we have to watch our loved ones die from a medicate that is suppose to help them.

  • GuadalupeNovember 23, 2020 at 1:19 am

    I have been taking methotrexate for over 18 years, now developed pulmonary fibrous, ever day i have trouble breathing. A lot of coughing.

  • AprilNovember 22, 2020 at 2:53 am

    My husband mother took this drug, and passed away. No one told her or my husband of the side effects.

  • NaomiOctober 9, 2020 at 1:54 pm

    My mother was prescribed methotrexate a month and a half ago for RA and she is now in ICU fighting for her life on life support

  • MaryOctober 9, 2020 at 4:01 am

    My husband's death certificate says he died of liver failure due to methotrexate use.

  • StanlySeptember 14, 2020 at 2:29 am

    My father was on methotrexate and he died because of this drug. For a year and a half my father was taken to the emergency room and everytime he went always the same diagnosis well your a smoker and you have bronchitis or upper respiratory infection. But all that time my father was suffering from all the side effects of this drug and doctors never once checked to see if what my father was going th[Show More]My father was on methotrexate and he died because of this drug. For a year and a half my father was taken to the emergency room and everytime he went always the same diagnosis well your a smoker and you have bronchitis or upper respiratory infection. But all that time my father was suffering from all the side effects of this drug and doctors never once checked to see if what my father was going thru was side effect related from this drug. My fathers throat was shrinking and also the flap that keeps food and water from going to his lungs was not working properly. With my dads throat shrinking it was hard for him to swallow food and got so bad my mom had to purae his meat and anything solid. When my father passed away we didn’t know all this and cause of my fathers death until my mom got the death certificate and clearly says caused from methotrexate.

  • GladysAugust 25, 2020 at 7:11 pm

    My Mom suffered with arthritis, she was prescribed methotrexate in the late 90's taking on a regular basis, she regularly went to doctor appointment, she suddenly develop ulcers in her mouth, dark tarry stool, extremely low blood count, her doctor admitted her to hospital right away, team of doctors did every test, medicine to attempt to reverse the effects of methotrexate, infectious disease doct[Show More]My Mom suffered with arthritis, she was prescribed methotrexate in the late 90's taking on a regular basis, she regularly went to doctor appointment, she suddenly develop ulcers in her mouth, dark tarry stool, extremely low blood count, her doctor admitted her to hospital right away, team of doctors did every test, medicine to attempt to reverse the effects of methotrexate, infectious disease doctor trying all sorts of medication nothing was working, she was placed on a respirator for 14 days, no hope of recovery her body couldn't fight off infection she was sepsis shock. My Mom passed away in 2016 after been removed off life support. I filed a complaint with FDA, this is a dangerous drug, lack of monitoring by some physician makes it even worse.

  • KristenAugust 10, 2020 at 4:39 am

    I was originally prescribed methotrexate for my severe rheumatoid arthritis back when I was 23 years old. Im a researcher always have been and when I had seen that a pdr said not to give to a cancer patient unless they were on deaths door step , to say I became concerned would be putting it mildly but when I brought these concerns to every dr and nurse and pharmacy i had contact with all i was tol[Show More]I was originally prescribed methotrexate for my severe rheumatoid arthritis back when I was 23 years old. Im a researcher always have been and when I had seen that a pdr said not to give to a cancer patient unless they were on deaths door step , to say I became concerned would be putting it mildly but when I brought these concerns to every dr and nurse and pharmacy i had contact with all i was told was that unfortunately it was necessary. Years later I had been diagnosed with more and more autoimmune diseases such as vasculitus and sle (lupus) which i had had nothing but problems already with the methotrexate such as almost no red blood cells bc if i wasn't vomiting the blood the methotrexate was killing it. Then to be hit with more illnesses was upsetting to say the least bc i thought that was why i was taking this "uranium" as i called it. Each one of my organs have all come to the brink of failing including my hear. Which is the only reason they aren't still pushing that stuff on me to this day.... They ruined all my organs over 10 years.

  • DanJuly 8, 2020 at 4:42 pm

    Prescribed methotrexate and gangrene set in on four fingers, taken off this drug I healed but lost use of fingers and lost tips of fingers. Prescribed drug again and gangrene popped up on another finger, asked to come off it as it also made me feel unwell. Haven't had gangrene again I know this drug caused me to have gangrene.

  • DOLORESJune 26, 2020 at 11:18 pm

    My husband had rheumatoid arthritis and was prescribed methotrexate. It took it for several years and became lll with lung issues after several years of taking methotrexate you're struggling to breathe. We took him to Mayo Clinic who in turn assisted us to get him to UCLA for lung transplants. Doctors at UCLA advised us that what is a side effect of methotrexate. My husband survived 4 possibly 7 [Show More]My husband had rheumatoid arthritis and was prescribed methotrexate. It took it for several years and became lll with lung issues after several years of taking methotrexate you're struggling to breathe. We took him to Mayo Clinic who in turn assisted us to get him to UCLA for lung transplants. Doctors at UCLA advised us that what is a side effect of methotrexate. My husband survived 4 possibly 7 years and died of rejection in the 2012. I believe if he had not been prescribed Methotrexate he would be alive today. He may have had some arthritic pain and other complications but he would be alive. I would like to be considered 4 the lawsuit against methotrexate

  • TonyJune 25, 2020 at 10:40 pm

    My cousin had been taking Methotrexate and it has caused her to be stage 4 cancer . . . she is often to weak to research and even answer phone calls can you please email me about a class action suit so i can share this info with her and help her get an attorney

  • Jehad AJune 10, 2020 at 10:21 pm

    I have developed Intertistial lung disease as result of Methotrexate. I was prescribed for auto Immune system. But this medication has destroyed my lungs. I developed Intertistial lung disease. My lungs are working at 80 percent capacity. Im.suffering every day of my.life. do not take it. It has destroyed me.

  • DulcieApril 26, 2020 at 2:06 pm

    My husband, who took Methotrate for Crohns passed away December 26, 2019. Once diagnosed with MDS, the oncologist doctor said it was from this medicine..... Please write me. I would like to join the class action lawsuit

  • patrickApril 25, 2020 at 9:53 pm

    my mother died of a sudden heart attack after taking this medication. she had rheumatoid and psoriatic arthritis. no one warned us now she’s dead at 57.

  • TerandaMarch 27, 2020 at 10:17 pm

    My father has been receiving treatment through the VA System for years. They won't give him veteran benefits although he was honorably discharged and drafted that triggered the autoimmune disease (polymyocytis) he has now. He was placed on methometrexate around 2008 and they had him on it for about 2 years till I took myself of after they told him it was leading to the sores on his tongue and ulc[Show More]My father has been receiving treatment through the VA System for years. They won't give him veteran benefits although he was honorably discharged and drafted that triggered the autoimmune disease (polymyocytis) he has now. He was placed on methometrexate around 2008 and they had him on it for about 2 years till I took myself of after they told him it was leading to the sores on his tongue and ulcers in his stomach and gave him erosion on his stomach. He is now still vomitting blood periodically. Is he eligible for this lawsuit?

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