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Methotrexate Medication Errors Resulting In Injuries, Deaths: Report

  • Written by: Irvin Jackson
  • 14 Comments

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.

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.”

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14 comments

  1. Teranda Reply

    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?

  2. patrick Reply

    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.

  3. Dulcie Reply

    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

  4. Jehad A Reply

    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.

  5. Tony Reply

    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

  6. DOLORES Reply

    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

  7. Dan Reply

    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.

  8. Kristen Reply

    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.

  9. Gladys Reply

    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.

  10. Stanly Reply

    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.

  11. Mary Reply

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

  12. Naomi Reply

    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

  13. April Reply

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

  14. Guadalupe Reply

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

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