10/28/10 A drug maker is voluntarily recalling vials of injectable methotrexate after small flakes of glass were found in some of the medication. The company says this has the potential to damage patient’s blood vessels or lead to swelling and even death, although the company isn’t aware of any reported problems so far.
Methotrexate is a disease-modifying antirheumatic drug, or DMARD. It is one of the most commonly prescribed medications for rheumatoid arthritis, or RA, a disease in which an overactive immune system attacks the joints and other tissues and organs. Methotrexate is taken to slow the progression of RA. It is also used for juvenile arthritis, severe psoriasis and some forms of cancer.
Sandoz, the generic pharmaceuticals division of Novartis in Princeton, N.J., is one of several suppliers of generic methotrexate. The company is voluntarily recalling all of its 50mg/2mL and 250mg/10mL vials of injectable methotrexate that are part of the Sandoz and Parenta brands and have expiration dates ranging from December 2010 to March 2012.
“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 company explained in a press release.
The U.S. Food and Drug Administration has been notified of the recall. The company is also alerting retailers, wholesalers, pharmacies, doctors and patients. The company says people should stop using the methotrexate they have immediately if it’s part of the affected lots. You can find the affected lot numbers on the Sandoz U.S. website and for more information, visit www.us.sandoz.com.
Donald Miller is chair of the pharmacy practice department at the College of Pharmacy at North Dakota State University in Fargo and a member of the Arthritis Today medical advisory board. He notes that injectable methotrexate comes in other doses, and arthritis patients may use smaller vials that aren’t part of this recall.
He also says that if patients have difficulty getting injectable methotrexate because of the recall, methotrexate tablets are a short-term option.
“If people are using the injections and they simply can’t get it, they can still take it by mouth. Most people take it by mouth in the first place,” Miller says. “Those who take it by injection usually have had some nausea with the tablets or they aren’t getting enough of an effect and they get a stronger effect from injections. But in a pinch you could certainly go back to taking it with a tablet.”
He says patients should definitely consult with their doctor about how to proceed.
Anyone who has a reaction to the medication should contact a doctor right away. The FDA can be notified of adverse reactions through its MedWatch Safety Information and Adverse Event Reporting Program. Click here to read the FDA's press release about the recall.
I had to use 20ml and throw the rest away for a few weeks because I could not find it anywhere else...
With preservative free ALWAYS throw it away after using what you are prescribed. Re-using it can cause infections.
I still haven't seen a new recall.
I was on MTX for a long time but had to switch to Immuran because of the lung problems.
Why Megan's doctor didn't order a chest xray is unbelievable. Does that doctor read the side effects of the drugs s/he prescribes?
given him subcutaneously every week, might
have been contaminated with glass flakes?
Maybe none of it, maybe some of it??
Is the pharmacy company going to give us
the specific 4 lot numbers out of the 24 they recalled??
As far as I can tell, the risk was there over
a full one year period- that is a long time-52 weeks of injections!
I didn't keep my old vials, have one full box barely used that is on the recall list,
another full box totally consumed, over an 18 week period that is on the list, and then 3 or 4 other prescriptions going back the past year where I have no way of telling if they are recalled lots or not.....but I would assume so because of approximate expiration dates. I can't even figure out
based on when I had a prescription filled when it would expire.....one year, two years??
It is all a mystery, the pharmacy can't give me old lot dates, all I can get is the date
I filled the prescription.
people online say that the hot line isn't helpful...
it just adds insult to injury that when you think you are doing the best thing for your child and having to administer this powerful drug, that there is possible contamination.
Thanks for listening. I just don't know what to do next.
any information would be greatly appreciated
My question to pose out there is this, is there anyone out there who has had issues with the biologicals, Enbrel, Humira, Remicaid, or any of the new ones, Symponi, etc? I took 11 infusions of Remicaid and developed Stage 4 Breast Cancer, which has now shown up in a couple of spots in one bone and a couple of spots in my liver. My docs say they can't say for certain it gave me the CA but they are very much on board with the fact that it was highly likely the cause to accelerate the spread. I had absolutely no history of breast CA in the family so that's why we are leaning towards the meds as a cause.
on saturday 10/30/2010 i recieved a text message to my cell phone from my walgreens pharmacy informing of a recall of one of my medications
i spoke with a pharmacy tech i said recall & he said methrotrexate
the pharmacist informed it was a a level 1
high alert recall that is why as soon as the information was entered into their system that the aumated alert system started calling all listed users of this drug
walgreens is replacing the vials with vials from another manufacturer while i was typing this the pharmacl called & informed me that the replacement is ready
monday 11/25 was my last injection befor the known recall the injection site has been tender & itchy all week
11/18 the injection was very hard had to push extra hard on the plunger
well thats my 2 cents
If you go on the website, there are four notifications. Letters to the patient, wholesalers, stores, etc. What disturbs me greatly is the letter to the individual about returning the vials and get them replaced....BUT no side effects mentioned. The letter to the vendors(Walgreen's, etc.)list many possible side effects.
I called the hotline number and they were very callous. They already have a legal department on hand to handle complaints. I am NOT returning anything until we get some answers.
Thank you so much for putting this out. My pharmacy has not contacted me. I do have this batch of vials. I am curious to see if the pharmacy has this batch.
I am so happy I subscribe to AT!
My last injection didn't really work as I was unable to draw the meds up into the syringe and didn't have another syringe. I suspect the vial was one contaminated with glass causing the problem. I have never had a problem in the 4 years I have been taking injectable. I am a retired nurse and ,yes, I do know how to draw meds into a syringe.
i I have had r.a. sence 1992 thankss again
I injected one of the vials and now have a bruise at the injection site. That is unusual so I am going to call me dr Monday.
I noticed several people asked if their medications were on the recall list including their oral pills. Please folks, there is a link directly to the list of the affected vials and the recall does not include oral pills.
By the way, if your doctor hasn't tried you with this combination and you aren't getting good enough relief ask them about MTX and Docycline. I've been on MTX and Docycline for the last year with good results, being as nowhere does our budget include money for those other drugs like Humira and Enbrel!
Thank you for the warning notice. Any news on medications is a must.
injected into juice, and have to also inject Enbrel once a week in addition.
Kindly inform me whether I should return the
2 vials of Methotrexate on hannd to my pharmacist.
Please reply asap.
Thank you! Ingrid Fish
Lighten up Connie, doesnt mean he's glad anyone else is affected, he is fortunate his isn't.
Hopefully you are not personally affected, nor any one else in danger. Thanks for the info Arthritis Mag's
do i am save with the tablets,12,5 mg.
together with humira injecktions
Really appreciate the quick notice on this recall.
THANKS for the heads up.
Leave a Comment