Injectable Methotrexate Recall | Methotrexate Arthritis | Arthritis Today Magazine

Injectable Methotrexate Recalled
Some vials of the drug, a mainstay of rheumatoid arthritis treatment, are tainted, posing a risk to users.

By Jennifer Davis

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.
Injectable Methotrexate Recall | Methotrexate Arthritis | Arthritis Today Magazine