Oct 4, 2012 10:42 PM
Oct. 4, 2012 -- Patients in 23 states are being warned that the spinal steroid shots they received may have given them a rare and deadly fungal meningitis.
So far, there have been 35 cases and "at least five deaths," according to the CDC, which expects the case count to rise. There have been 25 cases and three deaths in Tennessee, four cases and one death in Virginia, two cases and one death in Maryland, two cases in Florida, one case in North Carolina, and one case in Indiana.
All cases are linked to spinal shots with three specific lots of a steroid called methylprednisolone acetate. The drug, without preservatives, was made and placed in syringes by a single firm, New England Compounding Center (NECC) of Framingham, Mass.
All three lots have been recalled. They were given to patients at 75 clinics in 23 states: California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas, and West Virginia.
The FDA's warning goes beyond the three recalled lots. The FDA and CDC are warning doctors, clinics, and hospitals to search their shelves for any products made by NECC and to not give them to patients until further notice. It's also not yet clear whether patients who received non-spinal shots of the tainted steroids are at risk.
Since last week, clinics have been trying to contact every patient that might have been infected. Neither the CDC nor the FDA knows how many patients received the shots, a common treatment for lower back pain.
"Unfortunately, despite the current recall, we expect to see additional cases as this investigation unfolds," CDC Medical Officer Benjamin Park, MD, said at a news teleconference. "However, it is possible that if patients are identified soon and started on appropriate antifungal therapy, some of the unfortunate consequences may be averted."
It can take as long as four weeks for these symptoms to appear. When they do, they begin gradually and may look a lot like the symptoms of other conditions:
"Patients may have mild symptoms not typical of meningitis," Park says. "If patients have new or worsening symptoms, even mild symptoms, they should be evaluated immediately."
Tests of spinal fluid show whether a person is infected. The fungus causing the infection is a strain of Aspergillus.
Treatment isn't easy. It requires intravenous infusions of one or two antifungal agents. Treatment must at least begin in the hospital and takes months to complete. There may be serious side effects.
NECC, the compounding pharmacy that made the contaminated steroids, has voluntarily closed its doors.
An FDA investigation found fungus growing in at least one unopened vial of steroids found at the company. Testing is under way to see if it is the same strain of Aspergillus growing in patients' spines.
NECC has surrendered its pharmacy license to the Massachusetts Board of Pharmacy, the FDA says.
Compounding pharmacies are regulated mainly by state pharmacy boards. Laws limit the FDA's regulatory authority over compounding pharmacies, which do not have to meet the extensive safety and effectiveness testing required of drug companies.