The Centers for Disease and Control and Prevention (CDC) and Food and Drug Administration (FDA) announced today they are advising medical professionals not to use any products manufactured by the New England Compounding Center in Framingham, Mass., due to an outbreak of fungal meningitis tied to some medications made by the company.
Three lots of the company's preservative-free methylprednisolone acetate that go back to July 2012 have been recalled and are believed to be the cause of the recent outbreak. Thirty-five cases of fungal meningtitis in six states have been identified, with five deaths. The majority of the cases, 25 in total, have been discovered in Tennessee.
"Given the severity of illness, we believe these precautionary measures are warranted to protect public health," Ilisa Bernstein, director of the FDA office of compliance, said to reporters during a conference call today.
Dr. Benjamin Park, medical epidemiologist with the Centers for Disease Control and Prevention, told reporters that 23 states may have received shipments of the tainted product. These states include: 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. A total of 75 facilities may have received product from one of these three recalled lots.
However, because the New England Compounding Center is licensed in all 50 states, there is a possibility contaminated products may be in other areas, Bernstein said.
"We don't know the scope of this," she admitted.
The initial three-lot recall by the New England Compounding Center involved 17,676 vials, the CBS News Investigative Team reported. There were two complaints filed against the company -- one in 2002, one in 2003 -- that were investigated and as a result the company entered into an agreement in 2006 with the Massachusetts Department of Health to correct any deficiencies. That same year, the FDA warned the company against compounding topical anesthetic creams for general distribution.
In March 2012, a complaint unrelated to the meningitis case was filed against the company regarding the potency of its eye medication. That complaint is still open and pending, according to the investigative team.
Fungal meningitis is a non-contagious form of the disease. It is often caused by fungus normally found in leaf mold. Authorities said some people were experiencing mild stroke-like symptoms, including slurred speech, and difficulty walking and urinating. Other fungal meningitis symptoms include worsening and severe headache, nausea, dizziness and fever.
It can be treated with high-dose antifungal medications, usually given intravenously in a hospital. The earlier the disease is diagnosed and treated, the better the chances of survival are.
"We think that early antifungal treatment can improve the outcome of these patients," Park said.
Park said that the CDC was notified of a patient with an onset of meningitis 19 days after receiving an epidural steroid injection on Sept. 21 in Tennessee. Although all initial cultures were negative, fungus was isolated from the patient's cerebral spinal fluid. On Sep. 28, the CDC was notified of cases outside of Tennessee.
In total, one case in North Carolina, two cases in Florida, four cases in Virginia, two cases in Maryland and one case in Indiana have been discovered in addition to the 25 cases in Tennessee. Three people have died in Tennessee, as well as one person from Virginia and one person from Maryland.
The victims tend to be elderly because of the nature of patients who receive spinal epidural injections because of lower back pain. Overall, many of the patients were somewhat healthy until infection.
On Oct. 1, the New England Compounding Center voluntarily shut down their manufacturing center. During a FDA investigation of the plant, the investigators discovered contaminants in an unopened vial.
"Materials from an unopened vials was looked at under the microscope at an FDA lab and what was looked at under the microscope looked like a fungal matter," an FDA spokesperson confirmed.
The FDA added that they are working with the firm to get more information about their products. The investigation is ongoing.