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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
Krista Cormier
on
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
Mary Muscarello
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
Lori S Campbell
on
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
Erin
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
Lisa
on
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
Beverly Disney
on
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
Johnna Weaver
on
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
Mike
on
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
Melissa andrews
on
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
Luther Elrod
on
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
Bettie Willians
on
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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