Dept. of Health warns of infections tied to Tennessee pharmacy - WKRN News 2

Department of Health warns of infections tied to Tennessee pharmacy

Posted: Updated: May 24, 2013 08:46 PM

The Tennessee Department of Health is investigating several infections believed to be tied to a compounding pharmacy in Newbern, Tenn.

The department says seven people have had adverse reactions to methylprednisolone Acetate (MPA) injections, including one fungal infection.

MPA is the same drug at the center of a fungal meningitis outbreak in the fall of 2012.

More than 55 people have died and over 740 others have been sickened after receiving contaminated injections from a Massachusetts compounding pharmacy.

The steroids are usually used to treat pain. The medication was designed to be injected into joints, muscles and administered as an epidural.

Patients who had adverse reactions had abscesses that appeared on their skin at the injection site.

The department of health said the suspect injections were produced at the Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tenn.

"Fortunately we are not aware of any serious events like meningitis, stroke or death in association with this cluster," Tennessee Department of Health Commissioner Dr. John Dreyzehner said during a conference call with media outlets. "But still our heart goes out to those affected by this event."
Department officials said the doses were produced after December 6, 2012 and distributed to clinics in Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina and Texas.

They also said seven clinics in Tennessee received doses from the suspect lot of medication.

"Its very important to note that based on everything we know right now this situation does not approach the severity of the fungal infections outbreak we encountered in the fall of 2012," Dr. Dreyzehner said.
Health officials are working with health departments in all the states where the doses where distributed as well as with the FDA.

The Main Street Family Pharmacy has issued a voluntary recall of all of its sterile products.

Pharmacy was licensed by the Tennessee Board of Pharmacy in 1985 and licensed as a manufacturer/wholesaler/distributor in 2010.

The pharmacy released a statement about the investigation Friday.

"As the FDA reported, an investigation into the exact source of the potential adverse effects from methylprednisolone acetate is inconclusive and ongoing," Spokesman Joe Grillo wrote.

He continued, "The company is fully supportive and compliant with the FDA's recommendation that patients not be administered this compounded medicine until the investigation is complete. In it's more than 17 years of operation, patient safety has always been and will always be Main Street Family Pharmacy's top priority."

According to the Tennessee pharmacy board the Main Street Family Pharmacy has been cited in the past for violating board regulations.

The most recent was in March 2013 when the business was fined $25,600 and placed on three years probation for failure to comply with rules of the board.

Health officials are currently making contact with all patients who received injections from the suspected lot of MPA from the Main Street Family Pharmacy.

"This is very early in this rapidly evolving investigation," Dr. Dreyzehner said. "We expect we will receive additional facts that will be important to this investigation."

He continued, "We are continuing efforts to obtain, confirm and validate information as we speak."

*The Associated Press contributed to this story.

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