A steroid medication has been recalled across the U.S. due to an association with a potentially fatal meningitis that has killed seven people. The company who manufactured the drug have shut down production and U.S. FDA has launched an investigation.
The Herald reports that the Massachusetts Board of Pharmacy is investigating an outbreak of fungal meningitis which is linked to a drug called methylprednisolone acetate. The Digital Journal earlier provided an initial warning about the recall. More details about the extent of the issue, linked to a 'big pharma' company, have now emerged.
Methylprednisolone acetate (80mg/ml) is an injectable steroid produced and distributed by New England Compounding Center (NECC) in Framingham, Massachusetts. It does not contain a preservative.
The medicine is used to treat pain and swelling that occurs with arthritis and other joint disorders. This medication may also be used to treat various conditions such as blood disorders, severe allergic reactions, certain cancers, eye conditions, skin, intestinal, kidney and lung diseases, and immune system disorders. Some 17,676 single-dose vials of the steroid were distributed throughout the U.S.
According to the Daily Mail, seven people, have died due to the contaminated medication and over sixty are ill. So far incidents have been recorded in 23 states. The latest two deaths were reported on Saturday in Michigan, according to the Daily Times.
The BBC notes that the majority of the cases have been in Tennessee, where a total of 29 people have fallen ill. It is not certain how many people have been exposed to the contamination because fungal meningitis can have a lengthy incubation period.
The U.S. Food and Drug Administration (FDA) has reported, via its MedWatch service, that the Agency has observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of methylprednisolone acetate collected from New England Compounding Center (NECC).
The U.S. Center for Disease Control (CDC) has interim data which shows that all infected patients received injection with this product. In the meantime, the FDA has stated that it is in the process of conducting additional microbial testing to confirm the exact species of the fungus. Fungal meningitis is rare and usually the result of spread of a fungus through blood to the spinal cord.
In addition, the FDA is in the course of inspecting the New England Compounding Center. Due to the report incidents, the firm voluntarily ceased all operations and surrendered its license to the Massachusetts Board of Registration in Pharmacy on October 3, 2012. The Guardian notes that in 2006 the firm received an FDA warning letter which highlighted process concerns.
The extent of these concerns maybe wider than first thought. The FDA has widened its original recall to include not only methylprednisolone, but also other steroid compounds compounded by the NECC, such as betamethasone, dexamethasone, triamcinolone, two local anesthetics called lidocaine and bupivicaine, the blood pressure drug clonidine, and saline.
Furthermore, the FDA has recommended that health care professionals and consumers not use any product that was produced by NECC. Any remaining stocks in circulation should be retained and secured until FDA provides further instructions regarding the disposition of the material.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.