UPDATE: Multistate Investigation Associated with Steroid Injections
May 29, 2013
FOR IMMEDIATE RELEASE
May 29, 2013
Contact: Communications Office
TALLAHASSEE—The Florida Department of Health (DOH) today confirmed 13 cases of adverse reactions associated with steroid injections of methylprednisolone acetate (MPA). DOH is working with the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), state partners and other state health departments to monitor nationwide reports of adverse reactions associated with MPA products compounded at Main Street Family Pharmacy, LLC.(Main Street), of Newbern, TN.
To date, no reports of meningitis or life-threatening infections have been reported. At this time, each of Florida's currently identified cases of adverse reaction are associated with skin abscesses following intra-muscular injections of MPA.
Additionally, DOH was notified of one additional Florida facility in receipt of Main Street products, bringing Florida's total number of facilities in receipt of Main Street products to four. At this time, the current list includes: Southern Healthcare Rural Health Clinic of Bonifay, Family Health Care of Chipley, The Back Center of Melbourne and Dr. Parvesh Bansal, also of Melbourne. DOH has notified each of these facilities and is currently working with them to notify patients who may have been exposed.
Main Street has voluntarily initiated a recall of all sterile products, including MPA, in cooperation with state and federal authorities. Out of an abundance of caution, the FDA recommends all health care providers stop using any sterile products from Main Street and isolate them until further guidance is provided.
Any Florida health care licensee requiring assistance to report a potential adverse reaction following an injection of MPA is encouraged to contact their local county health department.
The exact source of these adverse reactions is unknown at this time and DOH will continue working with state and federal partners throughout this ongoing investigation.
The Florida Department of Health works to protect, promote & improve the health of all people in Florida through integrated state, county, & community efforts.
A video statement from the Department regarding this investigation will soon be able available on our DOH Online Newsroom. Follow us on Twitter at @HealthyFla and on Facebook. For news story ideas, interviews, videos and more from DOH Communications visit the DOH Online Newsroom.