Patients may have received contaminated steroid injections from the New England Compounding Center for treatments in their ankles, knees and other joints, and may present signs of infection, health officials announced Thursday.
Officials had previously said most of those at risk received epidural steroid injections to relieve back pain. On a Thursday conference call with reporters, the Centers for Disease Control and Prevention (CDC) said it was alerted to one case of a person who may have developed a fungal infection after receiving a steroid injection in his or her ankle. While the case hasn't been confirmed to be caused by a fungus, the person received the same steroid injection as the confirmed fungal meningitis cases and is showing symptoms consistent with a fungal infection.
The CDC said there are 170 reported infections tied to an 11-state meningitis outbreak, including 14 people who died.
In total, up to 14,000 people may have received the contaminated injections, said health officials; previous estimates suggested that number was closer to 13,000 patients. The CDC reported it has successfully tracked down nearly 12,000 of these patients -- about 90 percent -- to inform them of their risk.
The ongoing outbreak is tied to contaminated methylprednisolone acetate steroid injections made by specialty pharmacy New England Compounding Center. After contaminants were discovered in an unopened vial during a late September inspection at the Framingham, Mass., facility, three lots of single-dose vials of the steroid that were sent to 76 facilities in 23 U.S. states -- in total 17,676 vials -- were recalled.
States that received injections include: 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. However, because the company is licensed in all 50 states, there is a possibility products may have shipped elsewhere.
On Thursday Dr. J. Todd Weber, incident manager of the multi-state meningitis outbreak at the CDC, told reporters that there were169 confirmed cases of fungal meningitis and one infection involving the ankle injection. The person showed symptoms consistent of a fungal joint infection, such as pain, redness and swelling; however, laboratory tests still need to confirm the fungus that caused this particular infection. Steroids can also be used to relieve pain in ankles, knees and other joints.
New details have also emerged about the particular type of fungus involved in the meningitis outbreak. As of Oct. 10, the CDC's fungal disease laboratory has confirmed the presence of the Exserohilum fungus in 10 people with meningitis and the fungus Aspergillus in one person with meningitis -- the latter being the first case linked to the outbreak that occurred in Tennessee. Up to three other cases tied to Exserohilum fungus have been confirmed in non-CDC labs, Weber added.
Interestingly, Weber noted, Exserohilum bacteria have not historically been known to cause fungal meningitis.
"This is new territory for public health and the clinical community," Weber warned.
Dr. Deborah M. Autor, deputy commissioner for global regulatory operations and policy at the Food and Drug Administration, said Thursday during the press conference that more than 50 unopened vials have been found to be contaminated at facilities across the country in addition to the center based in Framingham, Mass. Tests are ongoing to verify the type of fungus found in those vials. Autor said the agency ruled out contamination of epidural trays made by other companies which held the vials. Previously, officials had noted one contaminated vial was found during an inspection at the New England Compounding Center.
Another company, Ameridose, which shares ownership with the NECC, Oct. 10 to assist in the investigation.
More cases of the infections are expected in coming weeks. Dr. Ben Park, medical officer of the CDC's Mycotic Diseases Branch, told reporters Thursday that the median time between the steroid injection and onset of symptoms is two weeks. However, the longest delay was found to be 42 days, with Park emphasizing the CDC does not yet know what the longest time gap will be.
Weber told reporters that patients who received these injections will need to be vigilant for months afterwards to see if they've developed an infection.
"We know we are not out of the woods yet," he warned.
and the government's regulation -- or lack thereof -- of such facilities. Compounding companies, which mix doses of medications to achieve different potencies, do not fall under the same FDA regulation as companies that manufacture drugs.
Dr. Madeleine Biondolillo, director of the health care safety and quality at the Massachusetts Department of Public Health, told reporters Thursday that the company violated Mass. state law that requires compounding companies to only mix drugs after receiving a patient's specific prescription, and were instead mass-producing compounded drugs. She noted her department does not oversee volume of medications the company distributed, and that interstate distribution from these companies needs to be regulated at a federal level.
During the press conference, health officials called for new regulations to ensure an outbreak of this magnitude does not happen again.