Thursday, April 30, 2015

FDA: Methotrexate Recall

The FDA has announced a recall of several medications including methotrexate:

FOR IMMEDIATE RELEASE – April 23, 2015 – Mylan N.V. (Nasdaq: MYL) today announced that its U.S.-based Mylan Institutional business is conducting a voluntary nationwide recall to the hospital/user level of select lots of the following injectable products due to the presence of visible foreign particulate matter observed during testing of retention samples.
NDC NumberProduct Name and StrengthSizeLot NumberExpiration Date
67457-464-20Gemcitabine for Injection, USP 200mg10 mL780139608/2016
67457-464-20Gemcitabine for Injection, USP 200mg10 mL780140108/2016
0069-3857-10Gemcitabine for Injection, USP 200mg10 mL780108907/2015
67457-463-02Gemcitabine for Injection, USP 2 g100 mL780122203/2016
67457-462-01Gemcitabine for Injection, USP 1 g50 mL780127305/2016
67457-493-46Carboplatin Injection 10mg/mL100 mL 780131206/2015
0069-0146-02Methotrexate Injection, USP 25mg/mL2 mL (5 x 2mL)780108207/2015
0069-0152-02Cytarabine Injection 20mg/mL5 mL (10 x 5mL)780105005/2015
Methotrexate Injection, USP 25mg/mL can be administered intramuscularly, intravenously, intra-arterially, or intrathecally and is indicated for certain neoplastic diseases, severe psoriasis and adult rheumatoid arthritis. The lot was distributed in the U.S. between Jan. 16, 2014, and March 25, 2014, and was packaged by Agila Onco Therapies Limited, a Mylan company, with a Pfizer Injectables label. Continue reading here
Thanks to for alerting us to this important piece of information.

While methotrexate is most often used in oncology and also for rheumatoid arthritis, on occasion it is also prescribed for other diseases, such as joint involvement in Sjogren's syndrome. Read this by Alan N. Baer, MD, FACP,  Director, Jerome Greene Sjogren's Syndrome Clinic found here:
The arthritis of primary SS is mildly inflammatory and a manifestation of the systemic autoimmune disease. The mechanisms responsible for this arthritis may include systemic factors which affect the joint tissue secondarily, such as immune complexes (which can induce inflammation in small vessels) or inflammatory mediators (such as cytokines, which induce physiologic changes in various tissues). Alternatively, the immune reaction may be directed specifically at a structural component of the joint, thereby inciting an inflammatory response. 
Many treatment modalities are available to treat joint pain associated with SS. If the joint pain is mild and intermittent, acetaminophen or short courses of non-steroidal anti-inflammatory drugs (NSAIDs) available without prescription may suffice. If the joint pain is more persistent, prolonged use of prescription-strength NSAIDs may be required. Chronic therapy with prescription-strength NSAIDs has a risk of inciting potentially dangerous stomach ulcers in up to 4% of patients each year, particularly in elderly individuals as well as those who are taking blood thinners or corticosteroids or who have had a prior history of stomach or peptic ulcers (12). Steps can be taken to reduce this risk. These include using the lowest dose that controls the joint pain, taking the NSAID with food, choosing an NSAID with a lower risk of gastrointestinal side effects, and taking a proton-pump inhibitor, such as omeprazole or pantoprazole, along with the NSAID on a daily basis (13). Hydroxychloroquine (Plaquenil) is commonly used for treating joint pain in SS patients, based in part on its efficacy in treating the joint pain of patients with systemic lupus erythematosus and rheumatoid arthritis (14-15). It is generally well- tolerated but its use for a period of 10 years or more is associated with potential damage to the retina of the eye in 1 out of 1000 patients. Patients taking hydroxychloroquine for prolonged periods should thus have yearly eye examinations (16). 
More severe forms of arthritis associated with SS may require treatment with disease-modifying anti- rheumatic drugs other than hydroxychloroquine. These include methotrexate, leflunomide, cyclosporine, TNF antagonists (such as etanercept, adalimumab, and infliximab), and rituximab. Prednisone can be a very effective and quick-acting treatment for arthritis, but chronic therapy, even in low doses, leads to an increased risk of osteoporosis. Higher doses should only be used for short periods of time, since these can result in so-called Cushingoid side effects, such as weight gain, diabetes, bruising, and an increased risk of infection.
If you are taking methotrexate, check your medication container for lot number, size, and expiration date found on the graph above.

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