Oct. 3, 2012 at 3:37 PM ET
Four people have died and 22 were made sick by meningitis linked to a rare fungal infection blamed on contaminated steroids, health officials said on Wednesday. They are “almost certain” more will be identified before it’s over.
The 26 cases include 18 people in Tennessee, one in North Carolina, two in Florida, three in Virginia and two in Maryland, the U.S. Centers for Disease Control and Prevention reported. Two of the deaths were in Tennessee, one in Virginia and one in Maryland.
Several of the patients are seriously ill, says Tennessee Department of Health Commissioner Dr. John Dreyzehner. Two clinics have closed voluntarily and a third is no longer giving the injections.
Officials said the chief suspect is contaminated vials of a pain treatment injected directly into the spine. The drug is called methylprednisolone acetate.
“We have notified medical professionals the prime suspect for this outbreak is methylprednisolone,” Dreyzehner told reporters in a telephone briefing. He said it was not yet clear how widely the drug was distributed.
Late Wednesday, the Food and Drug Administration confirmed that New England Compounding Center, a Framingham, Mass., compounding pharmacy, on Sept. 26 voluntarily recalled three lots of 80-milligram injection doses of methylprednisolone acetate (PF) produced by the firm. The lots included #05212012@68 with a had beyond use date of Nov. 17, 2012; #06292012@26 with a beyond use date of Dec. 26, 2012; and #08102012@51 with a beyond use date of Feb. 6, 2013. The firm's website was not working on Wednesday evening.
It’s not entirely certain the steroid is to blame, said the health department’s Dr. Marion Kainer. The health officials, the CDC and the FDA are testing the pain medications and other materials used with the steroid injections, as well as samples from the patients. Patients were also treated with injections of lidocaine and a povidone iodine skin preparation solution, the CDC said.
Meningitis is an inflammation of the spinal cord, usually caused by bacteria or viruses. It can be very serious and is marked by a headache, fever, often a stiff neck and balance problems. Fungi and parasites can also cause this inflammation and in this case the common mold aspergillus is suspected. “The type of meningitis we are dealing with in this situation is not communicable person to person,” Dreyzehner said.
The 18 Tennessee cases are associated with Tennessee centers: Saint Thomas Outpatient Neurosurgery Center in Nashville, a center in Crossville, and now a third center in Oak Ridge, the officials said. The cases were all injected from two lots of steroids.
Everyone treated at the centers since July 1 is being cautioned to look for symptoms and to see a doctor immediately if they develop any. More than 700 people were treated, Dreyzehner said. “Everybody who been exposed to the lot numbers that are suspect, the vast majority have not been symptomatic,” he said.
The incubation period -- the time between treatment and the first symptoms-- ranges from two days to two months, the officials said. No one treated before July 30 has turned up sick but they said they were checking people back to July 1 out of an abundance of caution. The first 12 patients who were identified range in age from 49 to 89.
The CDC and FDA are testing samples of the drug, which has been recalled nationwide, as well as samples from the patients to be sure it’s aspergillus. Aspergillus has not been isolated yet from the steroid.
Aspergillus is tricky to treat. It’s an infection that patients with damaged immune systems can get – notably cancer patients and those with HIV infection. It’s often found in the lungs because the mold – found in dead leaves and elsewhere -- can be breathed in. An antifungal drug called voriconazole can treat the infection but the health officials said in this case they want to be sure before they try it. The side effects from the antifungal treatment can be severe and include kidney and liver damage.
It's also hard to reach an infection in the spinal cord.
The health officials stress that women who got epidural injections while giving birth are not at risk in this outbreak. In 2005, after a giant quake and tsunami devastated shorelines around the Indian Ocean, a team of doctors in Sri Lanka reported on an outbreak of aspergillus meningitis among women who got epidurals during childbirth. Five young women were infected and three of them died.
In that case, they reported in several medical journals, the anesthetics used had been stored in hot and dirty warehouses in the aftermath of the tsunami’s devastation.