October 16, 2012
Fungal Meningitis Reported In 15 States, 214 Cases Reported, 15 Deaths
Lawrence LeBlond for redOrbit.com - Your Universe OnlineNECC) in Framingham, Massachusetts during surgery, officials with the Food and Drug Administration (FDA) said in a statement.
A third infection occurred in a Pennsylvania patient who had received an epidural steroid injection in July from medications supplied by NECC. That person is being treated in a hospital, the Pennsylvania Department of Health said.
NECC had shipped more than 17,000 doses of the injectable steroid methylprednisolone acetate to 76 facilities in 23 states; Some 14,000 doses have been reportedly used. Some of those sickened by the contaminated injection have been hospitalized and are seriously ill.
Over the weekend the US Centers for Disease Control and Prevention (CDC) said 205 people had been stricken by the infection so far, with Illinois and New Hampshire also reporting their first cases.
Triamcinolone acetonide, an injectable steroid product also made by NECC, has also been identified as contaminated and had been reported to the FDA. The Pennsylvania case has been tied to this drug. Up until this point, all previous “cases of meningitis“¦have been associated with methylprednisolone acetate,” said officials with the regulator.
The FDA has yet to confirm the latest infections were caused by the NECC product.
“Investigation of these patients is ongoing; and there may be other explanations for their Aspergillus infection. Cardioplegic solution is used to induce cardiac muscle paralysis during open heart surgery to prevent injury to the heart,” the FDA said.
“The sterility of any injectable drug, including ophthalmic -- eye -- drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by the New England Compounding Center are of significant concern, and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection,” the regulator added.
At this time, no cases of infection have been linked to the ophthalmic drug produced by NECC, but the FDA is continuing to monitor the situation, noting that this class of products could potentially pose similar risks of infection.
The outbreak has caught the attention of President Barack Obama, who has noted his concern about the severity of illnesses. Jay Carney, a White House spokesperson told UPI reporters the president had been briefed on the situation and was “as concerned about it as you would expect given the severity of the impact on some people who have either died or gotten very sick.”
The CDC on its website said it is currently not recommending “empiric anti-fungal therapy for symptomatic patients who have normal cerebrospinal fluid laboratory examination. These patients should be closely monitored and re-evaluated for progression of symptoms“¦Should the patient have progression of symptoms, a lumbar puncture -- a spinal tap in which a thin needle draws fluid surrounding the spinal cord and the brain -- should be repeated immediately, using a different site than was used for the epidural -- lower back -- injection when possible.”
However, the CDC has listed a series of recommendations for physicians treating patients who were administered the steroid based on growing evidence that Exserohilum rostratum--a brown-black mold, or fungus--was the predominant pathogen in this outbreak. Also, expert opinion and published literature indicated the drug voriconazole might be effective in treating infections due to brown-black molds as well as infections due to the Aspergillus species.
The CDC said it is continuing consultations with health experts on treatment options for patients associated with this series of illnesses. The CDC is also recommending physicians of patients with fungal meningitis symptoms or infections should consult infectious disease experts for assistance.
Dr. J. Todd Weber of the CDC said treating the patients sickened by the contaminated steroid is "new territory" because it has never caused meningitis before.
“We have been working directly with the clinics to ensure that patients who received these injections are monitored and receive any necessary follow-up,” said Acting Pennsylvania Secretary of Health Michael Wolf.
Currently, Tennessee has seen the worst outbreak of the infection with 53 cases and six deaths. The state government suspended NECC´s license on Monday; NECC had already surrendered its license in Massachusetts, has halted operations and has recalled all of its products. Its sister company, Ameridose, has also suspended its operations.
A list of the NECC recalled products may be found on the FDA´s website.
NECC is facing a barrage of federal and state investigations. The outbreak has raised concerns about how the pharmaceutical industry operates, especially as NECC engaged in the little-known practice of drug compounding that is not regulated by the FDA.
In drug compounding, pharmacies prepare specific doses of approved medications, based on guidance from a doctor, to meet an individual patient's need.
An investigation by Reuters found that one NECC customer received solicitations from NECC for bulk orders and failed to require proof of individual patient prescriptions as required by state regulation. After failure to only deliver products in response to patient-specific prescriptions in Massachusetts was realized, the company forfeited its license there.
Several states are following the FDA and launching their own probes against the company, including Michigan, Massachusetts, Indiana, Montana and Ohio.
“We continue to cooperate with the FDA, as we are with the CDC and the Board of Registration in Pharmacy of the Massachusetts Department of Public Health,” said the NECC in a statement, adding that it was reviewing all information garnered by the regulator.
In Tennessee, where the most cases have occurred, 71-year-old Janet Russell was the first person to file a lawsuit against NECC seeking $15 million in damages after being diagnosed with meningitis. Russell claimed she contracted the infection after receiving an injection of methylprednisolone for back pain on August 30 at St. Thomas' Outpatient Neurosurgery Center.
Her lawsuit states that as a result, she is suffering constant pain, the effects of a stroke, permanent disability, and emotional distress and will need ongoing treatment due to the infection. Russell is currently in the hospital's intensive care unit, her attorney said.
U.S. Senator Richard Blumenthal of Connecticut called for an immediate criminal investigation of NECC and its officers and employees. “The scope of this disaster, which only increases by the day, is a call to action for increased federal oversight of these unauthorized drug manufacturers masquerading as compounding pharmacies,” he said in a statement.
The states that have so far reported cases of fungal meningitis include: Tennessee, Michigan, Pennsylvania, New Hampshire, Illinois, Indiana, Minnesota, New Jersey, Texas, Idaho, Maryland, North Carolina, Virginia, Ohio and Florida.