- 47 people in 7 states meet criteria for a non-contagious, fungal form of meningitis
- These patients were injected with steroid called methylprednisolone acetate
- The plant where the steroid was manufactured voluntarily shut down
Forty-seven people in seven states are now confirmed to have fungal meningitis, the Centers for Disease Control and Prevention reported Friday, 12 more than the day before.
The death toll hasn't risen. So far, five people have died after having a preservative-free steroid called methylprednisolone acetate contaminated by a fungus injected into their spine. Michigan, the latest state to find patients sickened by the drug is reporting four cases.
Physicians and clinics in 23 states are reviewing patient records to determine which patients may have received injections contaminated with a fungus. The Greenspring Surgery Center in Baltimore, Maryland, has determined that 300 patients received injections with the recalled drug -- manufactured by New England Compounding Center in Framingham, Massachusetts.
Robert Eisenberg, who is a nurse/administrator at the Baltimore facility told CNN no Greenspring patients are among the two confirmed cases in Maryland.
"Our doctors used it as standard medication," he said. "We trust that all drug manufacturers provide drugs that are safe for our patients. We are very disappointed that in this particular instance they were not safe and put our patients at risk."
While only certain doses of the injectable steroid are being recalled, as a precaution, FDA officials are asking doctors and clinics and consumers to stop using any products produced by the New England Compounding Center. NECC said in a statement Friday that "although there is no indication of any potential issues with other products," they stopped all operations for now and are cooperating with authorities.
The statement said "the fatalities and illnesses confirmed today by the CDC and FDA are tragic. The thoughts and prayers of everyone employed by NECC are with those who have been affected."
A total of 17,676 vials were in the three recalled lots produced by NECC, according to the Massachusetts Department of Public Health. Each vial is a single dose.
Health officials say approximately 75 medical facilities in 23 states have received products from NECC.
Those states are 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.
Nearly 10% of drugs administered in the United States come from compound pharmacies, according to a 2003 Government Accountability Office report.
Drugs manufactured by compound pharmacies do not have to go through FDA-mandated pre-market approval. Instead, oversight and licensing of these pharmacies comes from State health pharmacy boards. Compound pharmacists create customized medication solutions for patients for whom manufactured pharmaceuticals won't work, according to the International Academy of Compounding Pharmacists.
The FDA could not say how many patients may be have been exposed to this possibly contaminated steroid. Bernstein said she did not know how many doses were in each of the three lots of the drug. She emphasized that the investigation is still ongoing.
Federal health inspectors began inspecting the NECC plant on Monday. One of the inspectors said he saw foreign material in one unopened vial, but the investigation is not yet complete.
Fungal meningitis is "quite a rare infection," said Dr. Benjamin Park, from the CDC's Division of Foodborne, Waterborne, and Environmental Disease. But it's is not a required reportable illness, so it's unclear how often these types of infections occur.
Dr. William Schaffner, chairman of the Department of Preventive Medicine at Vanderbilt University Medical Center, told CNN that fungal infections are not usually mild. He said when funguses invade small blood vessels they can cause them to clot or bleed, which can lead to symptoms of small strokes.
Other symptoms of meningitis to look out for include fever, chills, new or worsening headache and stiff neck, said Schaffner.
If someone is experiencing any symptoms, they should seek medical attention immediately. The earlier a patient gets treatment, the more likely he or she will survive.
Patients are treated with anti-fungal medication, which is given intravenously so patients have to be admitted to the hospital -- at least in the beginning, said Park. He added that patients may need to be treated for months.
The FDA is urging anyone who has experienced problems following an injection with this NECC product, to report it to MedWatch, the FDA's voluntary reporting program, by phone at 1-800-FDA-1088 or on line at www.fda.gov/medwatch/report.htm.