Main Street Family Pharmacy (Newbern, TN) Confirmed As Source Of Fungal, Bacterial Taint In Steroids

[hatrack]

Both bacterial and fungal contaminants have been detected in unopened vials of drugs made by Main Street Family Pharmacy, the U.S. Food and Drug Administration said Thursday, providing the first direct evidence the Newbern, Tenn., pharmacy is responsible for a new outbreak involving a widely used steroid medication.

So far, methylprednisolone acetate from the pharmacy has sickened 24 people in Illinois, North Carolina, Florida and Arkansas. This is the same medicine previously made by Massachusetts-based New England Compounding Center that has sickened 745 people in the United States, with 58 deaths. The most serious consequence of that outbreak, which was first publicly reported on Oct. 1, 2012, have been cases of fungal meningitis.

In the latest outbreak, which was announced May 24, the majority of cases have been injection-site infections, which are less serious than meningitis. However, federal officials and state health departments are closely monitoring the situation. Main Street Family Pharmacy shipped the medicine, which is often used as a treatment for chronic pain in the spine and joints, to 17 states.

The FDA confirmed microbial contaminants in two vials from separate lots of preservative-free methylprednisolone acetate: 011413dan and 010913dan. However, all sterile drugs made by the pharmacy with a use date on or before Nov. 20 have been recalled. Seven Tennessee clinics, including one in White House, were among facilities that received the suspect medicine. But state health officials have not reported any illnesses from the latest outbreak involving methylprednisolone acetate.

EDIT

http://www.tennessean.com/article/20130607/NEWS07/306070088/Meningitis-outbreak-Drugs-from-TN-pharmacy-tied-illnesses?nclick_check=1

[blm]

1. GOP: Let's deregulate even more.

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