The number of deaths caused by a meningitis outbreak grew to 20 Thursday, as federal health officials for the first time confirmed the presence of a fungus in a contaminated steroid solution given to pain patients.
Investigator with the Centers for Disease Control and the Food and Drug Administration found a fungus known as Exserohilum rostratum in unopened vials of methylprednisolone acetate at the New England Compounding Center (NECC) in Framingham, Massachusetts. Health officials had strongly suspected the fungus was behind the outbreak.
The CDC estimates as many as 14,000 patients around the country were exposed to the contaminated steroid, primarily through epidural injections for back pain. The steroid was shipped to pain clinics in 23 states.
“We are working tirelessly with our state public health partners to track down patients who may have received these medications. If patients are identified soon and put on appropriate antifungal therapy, lives may be saved,” said Benjamin J. Park, MD, Chief Epidemiologist with the Mycotic Diseases Branch of the CDC.
Of the 47 patients with laboratory confirmed fungal meningitis, Exserohilum rostratum was found in clinical specimens for all but two. Of the other two patients, one was found to be infected with Aspergillus fumigatus and one with Cladosporium.
“Given that fungal infections of this kind have never been seen before, the doctors caring for these patients are going to need guidance. CDC has convened the nation’s top clinical fungal experts to work with us in developing diagnostic and treatment guidance for physicians caring for these patients,” said John Jernigan, MD, director of the CDC’s Office of Health Associated Infections Prevention Research. “Patients who are concerned about whether they were exposed to a potentially contaminated product should contact the physician who performed their injection.”
In all, 257 patients in 16 states have been infected with fungal meningitis, numbers likely to grow in the months ahead.
“Unfortunately, the incubation period for these infections, based on prior experience, may extend to months after exposure. Therefore, exposed patients will need to be followed for a long time,” said John Perfect, MD, of Duke University in an article published online in the Annals of Internal Medicine.
Perfect treated patients who became ill with meningitis after being injected with the same compounded steroid in 2002.
“A full decade after the 2002 fungal meningitis outbreak, we are again painfully reminded of the importance of sterility and the powerful disease-producing interactions between corticosteroids and fungi. Even at this early stage in the epidemic, it is clear that issues surrounding pharmacy compounding and its regulation will need to be revisited at the state and federal levels,” said Perfect.
Compounding pharmacies such as NECC produce custom medications used by millions of Americans. There over 7,500 compounding pharmacies in the U.S. Many are small “mom and pop” operations, but larger ones – such as NECC — sell products to hospitals, clinics and physicians around the country. Compounding pharmacies are regulated by state agencies, with little oversight by the FDA and other federal agencies.
Perfect said the FDA, health care providers and pharmaceutical companies need to restore public trust in health care by cleaning up the compounding industry.
“Otherwise, this will surely happen again,” he warned.