Oct. 11, 2012 -- The crisis surrounding the multistate outbreak of fungal meningitis linked to tainted steroid shots deepened Thursday, as federal officials reported that more people had received the shots than previously believed. Doctors also reported the first case of a joint infection outside the spine.
The CDC says close to 14,000 people may have gotten the shots, not 13,000 as was first estimated.
Fourteen people have died since the outbreak was first reported last month.
In all, 169 cases of the rare brain infection have been reported in 11 states. Tennessee, Michigan, Virginia, Indiana, and Maryland have been the hardest hit.
Most Already Contacted
“These 14,000 patients received the medication as a steroid injection either in the spinal area or into a joint space, such as a knee, shoulder, or ankle,” said J. Todd Weber, MD, chief of the Prevention and Response Branch, Division of Healthcare Quality Promotion at the CDC, in a press briefing.
Health officials have contacted about 90% of the affected patients to warn them about possible health risks related to the shots.
“We know we are not out of the woods yet,” Weber said, noting that it can take weeks to months to develop symptoms of a fungal infection. Those include headache, fever, back pain, nausea, and redness or swelling at the injection site.
“Patients and their doctors will need to be vigilant for at least several months following injection,” said Weber, who is leading the response to the outbreak for the CDC. He urged patients who were feeling unwell to seek immediate medical attention.
He also warned patients and doctors that it is difficult to test for the two fungi that have been causing the meningitis cases. The CDC confirmed the presence of the fungus exserohilum in 10 of the people with meningitis and the fungus aspergillus in one person with meningitis.
“Patients who received an injection with one of the three recalled lots of steroids may be diagnosed with meningitis, but their fungal testing may be negative. In these cases, patients should still be treated for meningitis,” Weber said.
So far, 50 vials of methylprednisolone acetate from the New England Compounding Center, in Framingham, Mass., have tested positive for two species of fungus linked to the outbreak.
First Joint Infection
In addition, federal officials said on Thursday that one patient had an infected ankle after receiving one of the shots. Doctors are waiting on a lab test to determine whether that infection was caused by a fungus, as the meningitis cases were.
In rare cases, fungal infections in the joints can cause septic arthritis, says Luis Ostrosky-Zeichner, MD.
“Infections in the joint are generally very severe because they destroy a lot of the lining of the joint, and they’re very disabling,” says Ostrosky-Zeichner, director of the laboratory of mycology research at the University of Texas Health Science Center in Houston.
Ostrosky-Zeichner says fungal arthritis may require surgery and months of treatment with intravenous antifungal drugs, which are known to be toxic to the kidneys and other organs.
“We know how upsetting these recent events have been, and we send our deepest sympathies to all who are impacted by this tragic situation,” said Deborah M. Autor, JD, deputy commissioner for Global Regulatory Operations and Policy at the FDA.
The FDA’s role in regulating compounding pharmacies was limited in 2002. The agency is largely empowered to act only after a problem has already been identified.
“What this points out is that the practice of pharmacy has changed quite a bit. The world has changed a lot since the days of mortar and pestle. This is the time for pharmacists, for lawmakers, for regulators, for doctors, to sit down and grapple with this new model of pharmacy compounding and come up with a regulatory scheme that controls the risk,” Autor said.