The Arkansas Department of Health is working with federal agencies to investigate reports of infections among patients treated with steroid injections distributed by a Tennesee compounding pharmacy to clinics in at least 15 states, including Arkansas.
About 20 patients who received injections of methylprednisolone acetate from the pharmacy after Dec. 6 have reported skin infections that led to abscesses at the site of injection andjoint infections, the state agency said. The injectable steroid is most commonly used to treat pain and swelling associated with joint conditions, such as arthritis.
The state Health Department is collecting information from 10 Arkansas clinics that received shipments of the drug to assist in a multistate investigation led by the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, said Dr. Dirk Haselow,epidemiologist forthe agency.
“We don’t know how many people have received [the steroid injection],” he said. “It could be in the thousands. We’ve heard from three clinics and we’re already up over 800.”
Haselow said he’s aware of three possible infections in Arkansas that may be related to the injections, but he has not confirmed the link.
The agency is collecting information about how and where the drug was injected and sorting patients into high-risk and low-risk groups. Patients at higher risk are those who had injections directly into a joint, such as the knee. Patients at a lower risk are those who had injections under the surface of the skin.
“All the states are really early in this investigation and trying to get a handle on what’s going on,” Haselow said.
He emphasized that reported infections related to the drug in question are much less severe than problems associated with drugs distributed by compounding pharmacies in the past, such as a 2012 fungal meningitis outbreak linked to a firm in Framingham, Mass.
Compounding pharmacies have traditionally mixed special batches of drugs for individual patients to meet specific needs. For example, a pharmacist may omit an inactive ingredient for a patient who is allergic to it.
But the pharmacies have stirred growing concerns from regulators as they have started mixing, distributing and repackaging large quantities of drugs for distribution over a multistate area. The pharmacies are governed by a patchworkof regulations created by the states they are located in, providing no consistent assurance of quality. And, because compounding pharmacies distribute large quantities of drugs created in one batch, a compromise of a product’s sterility can quickly affect thousands of patients, regulatory agencies have said.
The pharmacy that compounded the methylprednisolone acetate - Main Street Family Pharmacy in Newbern, Tenn. - announced Tuesday a voluntary nationwide recall of all lots of all sterile products it compounded with a use-by date on or before Nov. 20, a notice posted on the Food and Drug Administration website said.
Patients who received the steroid injections in Illinois, North Carolina and Florida have reported infections, the Health Department said. The product was also distributed in Alabama, California, Kentucky, Louisiana, Mississippi, New Mexico, South Carolina, Tennessee, Montana, Oklahoma and Texas.
According to the Health Department, Arkansas clinics that received the shipments are: Antoon Medical Clinic in Stamps, Lofton Family Clinic in DeQueen, Ouachita Family Practice in Mena, Reinhart Family Healthcare in Monticello, Monticello Medical Clinic in Monticello, Southern Medical Group in Magnolia, Chambliss & Davis Clinic in Magnolia, Coast to Coast Medical in West Memphis, Family Medicine in White Hall and Integrated Health in Fayetteville.
Patients who have any unexplained health problems following an injection of methylprednisolone acetate from one of the clinics should contact the clinic or their regular health care provider, Haselow said.
Northwest Arkansas, Pages 7 on 05/31/2013