Investigators in the US have raided the premises of Massachusetts pharmaceutical company New England Compounding Center (NECC) linked to fungal meningitis outbreak.
The Food and Drug Administration (FDA) raised concerns about sterility and cleanliness at the NECC.
So far 16 people have died from a rare fungal form of meningitis, apparently after using contaminated drugs.
More than 200 people in 15 US states have been affected.
Steroids and heart drugs produced by the Boston-based NECC are under investigation and the FDA has warned doctors not to prescribe any of the company’s products.
Meningitis is an inflammation of the membranes covering the brain and spinal cord. Symptoms include severe headache, nausea and fever as well as slurred speech and difficulty walking.
Fungal meningitis is not contagious, according to US health officials.
Criminal investigators from the FDA searched the NECC premises on Tuesday as part of a broad state and federal investigation into the deadly outbreak.
Paul Cirel, a lawyer for the pharmaceutical company, told Associated Press that it was “difficult to understand the purpose” of the FDA search. He said the company has made clear it would provide, and has provided, anything requested by investigators.
They have been several calls by US congressmen for a full-scale criminal investigation into the NECC’s practices.
The outbreak has raised questions about the practice of drug compounding, where pharmacies prepare specialized doses of medication. Compounding is not regulated by the FDA, which generally oversees drug makers.
NECC has suspended operations and recalled the steroid injection initially linked with the outbreak, methylprednisolone.
The FDA says it is looking into reports of a patient with possible meningitis who received an injection of triamcinolone, a different steroid, from NECC.
Two transplant patients also developed a fungal infection after receiving an unnamed heart drug made by the firm.
The FDA has not confirmed that these three infections were caused by NECC products, and has said that it is very possible that the heart patients were infected by another source.
On Monday, the drug regulator expanded its recommendation for doctors to warn anyone who received any injection made by the company, including drugs used in eye surgery.
Last week, health officials said 12,000 of the roughly 14,000 people in 23 states who received the steroid shots had been contacted.
The CDC has published a list of clinics that received shipments of the drug, which was recalled on 26 September.
Drug compounding:
• Drug compounding is used to make unique drugs for individual patients when there are no existing licensed treatments
• It is common practice around the world to make medicines for rarer conditions and children, for example
• Individual pharmacists or specialist drug companies combine, mix, or alter ingredients to create medications to meet these specific needs
• In the US, compounded drugs are not approved by the regulator the FDA, which means their safety and efficacy are unverified
• Poor practices on the part of drug compounders can result in contamination or in products that don’t possess the strength, quality and purity required
The US Centers for Disease Control (CDC) say 15 people have now died from an outbreak of fungal meningitis linked to steroid injections to treat back pain.
CDC said the latest death occurred in Indiana – the second in the state.
In all, nearly 200 people in 13 US states have been affected.
A company in Massachusetts earlier recalled more than 17,000 vials of steroid it had sent to more than 70 clinics across America.
Thirteen states have been affected: Tennessee, Michigan, Virginia, Indiana, Florida, Maryland, Minnesota, North Carolina, New Jersey, Ohio, Illinois, Idaho and Texas.
Fungal meningitis is not contagious, the CDC says.
Meningitis is an inflammation of the membranes covering the brain and spinal cord. Symptoms include severe headache, nausea and fever as well as slurred speech and difficulty walking.
The drugs have been traced to Massachusetts’ New England Compounding Center.
The drug manufacturer last week voluntarily recalled all products in circulation that were made at its Framingham facility.
Massachusetts health regulators have said there were complaints against the pharmaceutical company in 2002 and 2003.
According to the Massachusetts Health Department, 17,676 vials of the steroid methylprednisolone acetate were sent to 76 healthcare providers in 23 states between July and September.
The CDC has published a list of clinics that received shipments of the drug, which was recalled on 26 September.
Fungal meningitis outbreak death toll has risen to seven in U.S.
The disease has been linked to spinal steroid injections, sparking fear as new cases have been reported in nine states.
The potential scope of the meningitis outbreak, that has sickened 64 people, widened dramatically as health officials warned that hundreds, perhaps thousands, of patients who received steroid back injections in 23 states could be at risk.
The outbreak of the disease, known as Aspergillus meningitis, is caused by a fungus found in a spinal steroid injections, a fairly common treatment used to relieve back pain, according to the Food and Drug Administration (FDA).
The latest fatalities were reported in Michigan on Saturday, though the Michigan Department of Community Health said they would not provide more information on the two deaths until after the weekend.
The fifth victim, Diana Reed, died on Wednesday afternoon at St Thomas Hospital in Nashville, Tennessee, surrounded by family members.
Diana Reed, 56, is one of thousands of patients recently treated in Tennessee hospitals for back pain with a steroid epidural – a fairly typical treatment. But since then a tainted batch of steroids released across the U.S. has been linked to dozens of cases of fungal meningitis.
The injectable steroids responsible for Diana Reed’s death were produced by New England Compounding Center, a specialized pharmacy in Framingham, Massachusetts. The company has shut down operations and said it is working with regulators to identify the source of the infection.
It is not clear how many patients received tainted injections, or even whether everyone who got one will get sick.
So far, 64 people in nine states – Tennessee, Virginia, Maryland, Florida, North Carolina, Indiana, Michigan, Minnesota and Ohio – have contracted fungal meningitis, and five have died, according to the Centers for Disease Control and Prevention (CDC).
In an alarming indication that the outbreak could get a lot bigger, Massachusetts health officials said the pharmacy involved, the New England Compounding Center of Framingham, has recalled three lots consisting of a total of 17,676 single-dose vials of the steroid, preservative-free methylprednisolone acetate.
An unknown number of those vials reached 75 clinics and other facilities in 23 states between July and September, federal health officials said. Several hundred of the vials, maybe more, have been returned unused, one Massachusetts official said.
However, many other vials were used. At one clinic in Evansville, Indiana, more than 500 patients got shots from the suspect lots, officials said. At two clinics in Tennessee, more than 900 patients received them.
The incubation period before symptoms appear is 28 days, and is almost certain more cases will be reported say health officials, who are now calling this a national health crisis.
Unlike the more common viral and bacterial meningitis, fungal meningitis is not contagious. It is an inflammation of the brain and spinal cord.
Symptoms include a severe headache, nausea, fever, and dizziness.
The first patients identified in Tennessee experienced slurred speech, and difficulty walking and urinating.
The pharmacy voluntarily recalled three lots of the steroid Methylprednisolone Acetate on September 26 according to the FDA. The drug is primarily used to relieve back pain.
The drug was administered to patients in their late 40s to early 80s.
Tennessee’s S. Thomas Hospital, ground zero for the outbreak with a suspected 15 cases as of Wednesday with two in critical condition, reported having 2,000 vials of the steroid in stock before the threat was discovered.
“Some are doing well and improving. Some are very ill – very, very seriously ill and may die,” Tennessee health official Dr. David Reagan said.
In Tennessee alone roughly 1,000 people were administered the steroid.
The link between the injections and the meningitis was discovered by Tennessee physician April Pettit, who found the initial cases were all people who’d recently received an epidural.
Officials are still investigating how the steroid resulted in fungal meningitis.
New England Compounding Center released a statement promising to work with heath authorities to discover what happened. But company president and licensed pharmacist Barry J. Cadden has otherwise dodged interview requests and the company web site is down.
An archived version of the site notes the company is licensed to distribute drugs in every U.S. state.
New England Compounding Center is among the approximately 3,000 U.S. compounding pharmacies specializing in blending, liquefying, or combining medicines customized for patients unable to swallow tablets, require specific dosages, or who have allergies.
Such companies are regulated by the state boards of pharmacy that license them rather than facing the broader regulations traditional drug companies deal with.
The pharmacy has produced questionable products before. In 2006, New England Compounding Center was one of four companies ordered by the Food and Drug Administration to cease producing a topical anesthetic cream that was found to cause “grave reactions including seizures and irregular heartbeats”.
The cream was the cause of two deaths, neither tied directly to New England Compounding Center.
That same year the company was also cited for multiple violations of federal laws and regulations based on a 2004 review of its offices. They were charged with misbranding drugs prescribed for eye treatment, misbranding an anesthetic drug and failing to provide adequate directions for its use, and promoting the use of a cancer drug for an unapproved purpose.
An FDA warning letter admonished the company that it was “distributing an unapproved drug in violation” of federal regulations.
In 2010 the company was sued by an Illinois firm that alleged New England Compounding Center illegally hacked its database violating the federal computer fraud and abuse act. The case was eventually settled.
STATE-BY-STATE BREAKDOWN
Tennessee: The initial outbreak site with a suspected 16 cases, two of whom are in critical condition. Three others have already died.
North Carolina: The second state to report infection with one case found at an unidentified clinic.
Florida: Only two cases have been reported but health officials fear more may come forward.
Virginia: One person has died from fungal meningitis and three more cases are still being treated.
Maryland: Seven medical clinics in Maryland pulled their stock of a questionable steroid after one person died and two more cases were reported.
Indiana: At least five people in Indiana are sick with fungal meningitis, with no fatalities yet reported.
Michigan: There are at least eight confirmed cases of meningitis in Michigan, including two deaths.
Minnesota: Fungal meningitis has been diagnosed in two women hospitalized in Minnesota.
Ohio: Health officials reported Saturday of a 65-year-old man being treated for the meningitis after receiving the steroid.
An outbreak of rare fungal meningitis in the US has now affected 47 people in seven states, Center for Disease Control (DCD) officials say.
Doctors at about 75 medical clinics are being warned to alert patients who received suspect steroid injections.
Five people have died from the illness, which the CDC has linked to products from a Massachusetts-based pharmacy firm.
Officials say they found contamination in a sealed steroid vial at the New England Compounding Center.
The firm recalled the steroid doses and has since shut down operations, but the vials have already been shipped to 23 states.
Meningitis is an inflammation of the lining of the brain and spinal cord. Symptoms include severe headache, nausea, and fever as well as slurred speech and difficulty walking.
The fungal meningitis causing concern in the US is not infectious, the CDC says.
Confirming that 47 people were now affected – an increase of 12 in the space of 24 hours, the CDC said new cases were reported for the first time in Michigan.
In Tennessee, which has the majority of the cases, a total of 29 people have now fallen ill. There were six cases in Virginia, three in Indiana Indiana, two each in Maryland and Florida and one in North Carolina, the CDC said.
It is not yet clear how many patients may have been exposed to any contamination, and fungal meningitis can have a lengthy incubation period.
A briefing by the CDC and the Food and Drug Administration (FDA) on Thursday said a fungus linked to the steroid medication had been identified in tests of five patients.
“Out of an abundance of caution, we advise all health care practitioners not to use any product” from the company, said Ilisa Bernstein, director of compliance for the FDA’s Center for Drug Evaluation and Research.
New England Compounding Center is a type of pharmacy that mixes ingredients for customized medicines. The steroid in question was three lots of methylprednisolone acetate from the firm.
On Friday, the CDC listed about 75 clinics and medical centres that received the suspected lots, and told doctors to immediately contact patients who have had an injection.
Tests are under way to confirm if the contamination is the same fungus blamed in the outbreak. The disease cannot be passed from person to person.
Three people have died in Tennessee, with one death in Virginia and one in Maryland, reports say.
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