The U.S. arm of the pharmaceutical company Mylan N.V., registered in the Netherlands, has voluntarily issued a nationwide recall of one lot of injectable methotrexate (USP 25 mg/mL) because of the possible presence of visible foreign particles.
The recalled lot – No. 7801082 – was distributed in the United States between Jan. 16 and March 25, 2014, and was packaged by Agila Onco Therapies Limited, a Mylan company, with a Pfizer Injectables label. It was sold in 2mL bottles with an expiration date of July 2015.
Methotrexate injections – used to treat inflammatory types of arthritis such as rheumatoid arthritis (RA) and juvenile idiopathic arthritis (JIA), psoriasis and certain types of cancer – can be administered under the skin, into a muscle, artery or vein, or into the space around the spine. Using a sterile injectable that has foreign particulates has the potential for severe health consequences, depending on where it is delivered. But for people with inflammatory types of arthritis, who are most likely getting a subcutaneous (under the skin) or intramuscular injection, “if there are particles in there, it might hurt a bit more but it won’t cause any major harm,” says Donald Miller, PharmD, professor and chair of pharmacy practice at North Dakota State University, in Fargo. “The particles would stay in the skin or muscle and cause local inflammation.”
To date, Mylan has not reported receiving any reports of adverse events related to this recall, according to the Food and Drug Administration (FDA).
The bigger issue for patients who use injectable methotrexate may be a drop in supply. “There is actually a national shortage of injectable methotrexate,” says Miller. “There are numerous manufacturers and three of them are backed up.”
Patients may have other options. Miller says that patients can see if their pharmacy has nonrecalled methotrexate. Another option is switching to the newer auto-injected versions. “The auto-injectors are in good supply,” says Miller, referring to Rasuvo and Otrexup. “The biggest drawback is that they cost more” – because they are branded and not generic.
Miller says he expects the shortage to last several months, especially because hospitals are likely to get priority for supplying since they use injectable methotrexate to treat certain cancers.
Consumers with questions regarding this recall can contact Mylan Customer Relations from 8 a.m. to 5 p.m. EST Monday through Friday at 800/796-9526 or firstname.lastname@example.org.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these products. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail or fax (call 800/332-1088 to request a reporting form).