Two other drugs made by the Massachusetts pharmacy at the center of a deadly meningitis outbreak may be linked to the disease, U.S. health regulators said on Monday, potentially widening the scope of the health crisis.
The Food and Drug Administration said it was looking into reports of a patient with possible meningitis who received an injection of a different steroid than the one found to have caused 15 deaths. It also said two transplant patients were infected with the rare fungus linked to the meningitis outbreak after receiving a heart drug also made by the New England Compounding Center (NECC) of Framingham, Massachusetts.
Nine more people have been diagnosed with fungal meningitis linked to possibly tainted vials of the injected steroid methylprednisolone, bringing the number of cases to 212, according to the U.S. Centers for Disease Control and Prevention (CDC). A Tennessee woman among these cases filed a lawsuit on Monday against NECC seeking $15 million in damages.
The patient identified by the FDA as potentially having meningitis received an injection for pain of the steroid triamcinolone, also supplied by NECC.
The FDA said its investigation of that patient and the two who received the heart drug during surgery was ongoing, and it cautioned that any injectable drugs made by NECC, including those intended for use in eyes, are of “significant concern.”
The FDA has not confirmed that these three infections were caused by NECC products.
NECC said in a statement that it was reviewing the new information from the FDA. “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,” it said.
The meningitis outbreak expanded to 15 states on Monday as Pennsylvania reported its first case.
The Pennsylvania patient, who received the epidural steroid injection in July, was being treated in a hospital, the Pennsylvania Department of Health said.
The nine new cases include the one in Pennsylvania, five in Michigan, two in Ohio, and one in Minnesota.
TENNESSEE SUSPENDS NECC LICENSE
All but eight of the 23 states that received suspect medications from the Massachusetts specialist pharmacy have reported at least one case of fungal meningitis, a rare and deadly disease that has proven difficult to treat.
The suspect lots of steroid were shipped to 76 facilities in 23 states, including two locations in Pennsylvania.
“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.
Health authorities have said that nearly 14,000 people nationwide have received injections from the potentially contaminated medication originally linked to the outbreak.
Tennessee, the state worst affected with 53 cases and six deaths, suspended NECC’s license there on Monday. NECC had already surrendered its license to operate in Massachusetts and halted operations. It also recalled all of its products, including three lots of steroid that tested positive for fungus contamination.
A list of recalled NECC products on the FDA website ran 70 pages long. here
It contained drugs for dozens of therapeutic categories, including pain medicines, antibiotics, eye drugs, hair restorers and skin care products.
At St. Thomas hospital in Nashville, Tennessee, more than 275 people have undergone spinal tap tests, a painful procedure to determine if they have meningitis. Thirty-three of them were infected.
In Tennessee’s first lawsuit against NECC, Janet Russell, 71, claimed she contracted fungal meningitis after receiving one injection of methylprednisolone for back pain on August 30 at St. Thomas’ Outpatient Neurosurgery Center.
The lawsuit claims that as a result, she suffers pain, the effects of a stroke, permanent disability, and emotional distress and will need ongoing medical treatment. Her husband of 53 years filed the lawsuit with her on Monday.
She is currently in the hospital’s intensive care unit, her attorney said.
NECC is being investigated by federal and state authorities. Pharmacy company Ameridose, which shares common ownership with NECC, has suspended operations.
Meningitis is an infection of the membranes covering the brain and spinal cord. Symptoms include headache, fever and nausea. Fungal meningitis is not contagious.
The outbreak has raised questions about how the pharmaceuticals industry operates. NECC engaged in a practice called drug compounding that is not regulated by the FDA, which generally oversees drug makers.
In compounding, pharmacies prepare specific doses of approved medications, based on guidance from a doctor, to meet an individual patient’s need.
A Reuters investigation found that NECC solicited bulk orders from physicians and failed to require proof of individual patient prescriptions as required under state regulations, emails to a customer showed.
State pharmacy regulators have said that NECC violated its license in Massachusetts by not requiring patient prescriptions before shipping products.
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.
Several states, including Michigan, Massachusetts, Indiana, Minnesota and Ohio, are investigating the company.
The 15 states reporting cases of meningitis are Tennessee, Michigan, Pennsylvania, New Hampshire, Illinois, Indiana, Minnesota, New Jersey, Texas, Idaho, Maryland, North Carolina, Virginia, Ohio and Florida.
By Greg McCune and Bill Berkrot