FDA Issues Alert About Tennessee Pharmacy
The U.S. Food and Drug Administration has issued an alert about methylprednisolone acetate doses made at a lab in Newbern, TN.
That is the same steroid linked to a fungal meningitis outbreak but those doses were made in Massachusetts.
The FDA says seven adverse ‘events’ have been associated with injections of the steroid, which is commonly used as a pain treatment.
Main Street Family Pharmacy is the Newbern where the doses were made.
The Tennessee Department of Health issued this statement:
State and federal health organizations are conducting a cooperative investigation into reports of adverse events among patients in Illinois and North Carolina who received injections of methylprednisolone acetate (MPA) after Dec. 6, 2012, produced by Main Street Family Pharmacy, LLC, in Newbern, Tenn.
The organizations involved in the investigation include the Food and Drug Administration, the Centers for Disease Control and Prevention, the Illinois Department of Health, the North Carolina Department of Health and Human Services and the Tennessee Department of Health. Because the investigation is in an early stage, staff members with all agencies are working now to gather and process information and to communicate with affected facilities and patients.
The reports of adverse events are all from patients who received preservative-free methylprednisolone acetate (80 mg/mL) by injection. To date, the FDA has received seven reports of illness. Clinical information about these patients is pending. To date, no reports of meningitis or other life-threatening infections have been reported. MPA is typically used for reducing inflammation.
The first priority is to ensure all products from this pharmacy are no longer in use. In addition, patients who potentially received an injection of MPA compounded by the pharmacy, into a sterile space (e.g., spine, joint, eye), should be contacted. These patients and others who may have had other types of injections should be informed the MPA medication they received might have been contaminated and asked whether they are experiencing any symptoms that could indicate infection.
Health officials believe, in reviewing preliminary information about when the material could have been appropriately used, there is not an ongoing risk to those now needing treatments. Out of an abundance of caution, the organizations have implemented or are implementing actions to protect the general public. These include:
• A thorough examination of records from the pharmacy to determine when and where MPA products were shipped. It is known these products were distributed to facilities in 13 states including: Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee and Texas. Health departments and facilities in these states are being notified so they can participate in response efforts.
• A review of receiving facilities’ records to learn which of their patients may have been administered the medication in question. Health officials will work closely with these facilities to investigate possible adverse events among those patients who received the suspect medication and to assist with outreach efforts to communicate with other patients. It is too early to know how many additional patients, if any, may be at risk.
• Additional laboratory work to determine the cause or causes of these adverse events.
• An FDA/TDH on-site inspection of the facility, which began May 22. The pharmacy staff and management have been cooperative. The pharmacy has agreed to stop sterile compounding pending resolution of the current investigation.
• Main Street Pharmacy, LLC, has voluntarily initiated a recall of all sterile products, including MPA, in cooperation with state and federal authorities. Main Street Family Pharmacy, LLC, was licensed by the Tennessee Board of Pharmacy in 1985. It is currently on probation as a result of a recent inspection.
s that could indicate infection.