Biotech giant Sanofi Genzyme has initiated a voluntary product recall for one lot ofSynvisc-One,a brand of hyaluronic acid. The lot, which was found to contain contamination, has been linked to an unexpected increase in side effects. In an urgent “product hold” letter, doctors, clinics and pharmacies who received syringes from that lot were instructed to immediately stop using the injections on patients until the company can investigate.
Continue readingSynvisc-One Injections Recalled
At the request of the U.S. Food and Drug Administration (FDA), Endo Pharmaceuticals has removed from the market its long-acting opioid pain medication,Opana ER(oxymorphone hydrochloride extended release), which some patients with arthritis take tomanage chronic pain.
Continue readingAt FDA Urging, Drug Maker Pulls Opana ER Off Market
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.”
据美国食品和药物管理局(FDA)称，到目前为止，迈兰尚未报告收到任何与这次召回相关的不良事件的报告。
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.”
患者可能有其他选择。米勒说，患者可以看到他们的药房是否有未召回的甲氨蝶呤。另一个选择是切换到较新的自动注入版本。“The auto-injectors are in good supply,” says Miller, referring toRasuvoandOtrexup.“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 orcustomer.service@mylan.com.
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 theFDA’s MedWatch Adverse Event Reporting program在线或通过普通邮件或传真(致电800/332-1088请求报告表格)。