FDA finds fungus in steroid shots, meningitis toll rises
U.S. health officials made their first confirmation of the presence of a deadly fungus in one of three lots of steroids tied to a national meningitis outbreak as the death toll rose to 20 on Thursday.
The U.S. Food and Drug Administration said it was still testing two additional lots of methylprednisolone acetate, the steroid used to treat back pain, for the presence of the rare Exserohilum fungus. It is also testing other injectable drugs that were supplied by the New England Compounding Center, or NECC, in Massachusetts.
“Now we can definitively say that the injections are linked to the infection,” Dr. Tom Chiller, an epidemiologist with the U.S. Centers for Disease Control and Prevention, told Reuters in an interview. “To date, CDC has no firm evidence of infection in any patients beyond those exposed to the contaminated lots.”
THE CDC said the death toll climbed by one to 20, while nine new cases brought the national total to 254, including the first in New York - the 16th state with confirmed infections.
Michigan reported its fourth fungal meningitis death and new cases were also reported in Indiana, New Hampshire, New Jersey, Ohio and Tennessee. There are also three cases of peripheral infections in joints, the CDC said.
“There were a lot more spinal injections performed versus joint injections, but the infection rate may also reflect the fact that joint infections might be slower or the incubation period could be longer ... we just don’t know,” Chiller said.
“The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status,” the Food and Drug Administration said in a statement. “Symptoms for other possible infections may include fever; swelling, increasing pain, redness, warmth at injection site; visual changes, pain, redness or discharge from the eye; chest pain, or drainage from the surgical site (infection within the chest). Patients should contact their healthcare provider if they have any of these signs or symptoms.”
FDA enforcers raided NECC’s Framingham, Mass., facility on Tuesday night. Earlier in the day, FDA officials said inspections of the facility made them worry about the sterility of any of the pharmacy’s products.
Members of Congress said they wanted answers, although as of Wednesday they had not scheduled promised hearings. Massachusetts Rep. Ed Markey, a Democrat, noted that NECC distributed controlled substances including morphine and fentanyl without a proper license.
“The list of recalled NECC drug products appears to include nearly 1,000 formulations that contain controlled substances that fall under the jurisdiction of the Drug Enforcement Agency (DEA),” Markey said in a statement. NECC shipped more than 17,000 vials from the three suspect lots of steroid to clinics in 24 states. The pharmacy makes hundreds of more products.
About 14,000 patients are believed to have been exposed to the potentially tainted NECC steroid and some 97 percent of them have been contacted so far, the FDA and CDC said.
NECC issued a statement saying it was “earnestly focused on determining, along with these agencies, the cause of contamination in vials of this product - and to rapidly and professionally carry out a recall to remove all NECC products from circulation.”
Most of those sickened so far were injected with steroids from three particular lots made by NECC, and the sickest patients developed meningitis, an inflammation of the protective membranes, or meninges, covering the brain and spinal cord. The swelling is usually caused by bacteria or viruses, but meningitis can also be caused by a fungus. Most of those who died suffered strokes.
“As a result of the ongoing investigation of NECC, a patient with possible meningitis potentially associated with epidural injection of an additional NECC product, triamcinolone acetonide, has been identified through active surveillance and reported to FDA. Triamcinolone acetonide is a type of steroid injectable product made by NECC,” the FDA said in a statement.
In addition, two patients who got steroids made by NECC injected into their ankles have developed infections. CDC doctors say they’re still checking to see if the infections are fungal in nature. The two patients are not in danger of meningitis, CDC says.
At least one hospital system, Maryland-based Medstar, says it has begun compounding its own products when possible now to ensure their sterility. Bonnie Levin, who heads pharmacy services at Medstar, told NBC News the hospitals have rooms that are as sterile as operating rooms to do this.
So-called compounding pharmacies are frequently at the center of controversy. Under the FDA’s definition, compounding pharmacists are supposed to mix drugs to order only on an individual basis in response to a prescription from a doctor. FDA can step in if it suspects pharmacies are exceeding this authority, and if contamination is suspected.
U.S. doctors in Baltimore said early diagnosis and treatment of patients at risk of fungal meningitis was vital, based on the case of an otherwise healthy woman who declined rapidly after receiving steroid injections for neck pain.
Writing in the Annals of Internal Medicine, researchers at the Johns Hopkins School of Medicine described the deterioration of an unidentified 51-year-old who sought care in an emergency room for a severe headache a week after receiving an injection with tainted medication on August 31.
The CDC has said it learned about the fungal meningitis outbreak on September 21 and that it contacted patients injected as far back as May.
Patients found to be infected are treated with a fairly high dose of voriconazole, sold by Pfizer Inc under the brand name Vfend, which can cause side effects including “visual disturbances,” fever and headache.
“We are finding a fair amount of toxicity,” Dr. Carol Kauffman, infectious diseases chief at the University of Michigan Health System, said during an infectious disease and epidemiology conference in San Diego. “We don’t want to have 80-year-olds hallucinating. That’s indeed what is happening.”