The U.S. Food and Drug Administration has officially confirmed that the deadly meningitis outbreak that has now killed 20 people nationwide is linked to tainted steroid injections shipped from a Massachusetts pharmaceutical company.
In a statement released from the federal agency Thursday, the FDA confirms that both they and the U.S. Center for Disease Control and Prevention (CDC) found the presence of a fungus known as Exserohilum rostratum, which health officials have linked to the outbreak of fungal meningitis-a rare disease caused by the spread of a fungus through blood to the spinal cord-that has been reported in 16 states.
The fungus was found in steroid injections from the New England Compounding Center in Framingham, Mass.
The death toll jumped from 15 to 20 people on Wednesday and Thursday, with 5 new deaths having been confirmed by the center due to the disease, with approximately 257 individual cases of people being infected reported to the center.
The New York Times reported that the CDC has confirmed at least 9 new cases between Oct. 17 and 18, including the first case reported in New York which brought the total number of states reporting meningitis cases to 16.
Michigan has reported its fourth meningitis death-second only to Tennessee, which has 8 deaths from the meningitis outbreak confirmed-while new cases were reported in Indiana, New Hampshire, New Jersey, Ohio and Tennessee, the Times writes.
According to the FDA statement, the fungus was found in unopened medication vials that were tested at the disease control center.
"The laboratory confirmation further links steroid injections from these lots from NECC to the multi-state outbreak of fungal meningitis and joint infections," the statement reads.
The FDA says that estimates from both the center and state health department show that roughly 14,000 people may have received injections with the contaminated medications, and at least 97 percent of those people have been contacted to date.
Tom Chiller, deputy chief of the mycotic diseases branch at the Centers for Disease Control and Prevention, told the Wall Street Journal that while most patients have shown symptoms between one and four weeks after injections, incubation periods of up to six weeks have been reported.
The Massachusetts company, which is being sued by patients in Minnesota, Tennessee, Michigan and New Jersey, has since issued a recall of all of its products, including the steroid injections sent to at least 23 states.
A statement from the company released Thursday to NBC News read, "We are eager to review these findings as part of our continued cooperation with the CDC and FDA to identify the cause of this contamination."
The FDA is requesting for clinicians to report "any suspected adverse events" after the use of the recalled products to the agency's MedWatch program at 1-800-322-1088 or www.fda.gov/medwatch.