• Mass. to revoke license of firm tied to meningitis

    By Sharon Begley, Reuters

    NEW YORK - At least 13 times, the Massachusetts pharmacy linked to a deadly fungal meningitis outbreak shipped orders of injectable steroid before it obtained the results of sterility testing, Massachusetts health officials announced on Tuesday. Officials in that state have also voted to permanently revoke the pharmacy's license. 

    Twenty-three people have died and more than 300 have become ill with fungal meningitis linked to steroid shots from the New England Compounding Center in Framingham, Massachusetts. Medical experts say the outbreak is not over and there will be more cases in the coming weeks or months.

    In at least one case, NECC shipped methylprednisolone acetate, the steroid linked to the meningitis outbreak, 11 days before obtaining sterility results from an outside lab, Dr. Madeleine Biondolillo of the Massachusetts Department of Public Health said.

    Her department launched an investigation of NECC in September, soon after the compounding pharmacy was linked to cases of fungal meningitis from the injectable steroid. A compounding pharmacy prepares prescriptions for patients when a drug from a pharmaceutical manufacturer is unavailable or when the patient cannot take the standard medication because of allergies or other reasons.

    The investigation produced "substantial evidence" of problematic procedures, record-keeping and conditions inside NECC, Biondolillo said.

    Crucial sterilization procedures were not followed, and on 13 occasions NECC's pharmacists did not allow "even the minimum amount of time" to confirm that a batch of medication was sterile, she said.

    The pharmacy did not properly test its own sterilizing equipment, she said, and when it sent batches of drugs to an outside lab for sterility testing, it did not wait for the results to come back before shipping medication from the same lot to patients or physicians.

    Conditions at the pharmacy suggested numerous ways the contaminated methylprednisolone acetate could have become contaminated with fungus. Mats that technicians and pharmacists were supposed to use on their shoes before entering work areas "were soiled with assorted debris," Biondolillo said, and there was a leaky boiler next to a "clean room" that was supposed to maintain the highest barriers against contamination.

    Still, she warned, none of these problems has yet been "conclusively" linked to the fatal contamination.

    Another red flag, said Biondolillo, was that compounded medications ready for shipment "were not labeled with patient-specific identifiers, as is required under Massachusetts licensing regulations." That meant that NECC was "acting as a manufacturer" and not a traditional compounder as its state license required.

    The Massachusetts Board of Registration in Pharmacy, she said, voted to permanently revoke NECC's license and that of its three principle pharmacists, including owner Barry Cadden.

    Governor Deval Patrick said Massachusetts will regulate compounding pharmacies more strictly in the wake of the meningitis outbreak.

    It will require them to submit annual reports on the quantities of medications they are producing and shipping so that "we can identify those acting like manufacturers" rather than traditional compounders, Patrick said.

    Massachusetts also will conduct annual inspections of the 25 compounding pharmacies in the state, Patrick said, and require them to report to state public health officials all interactions with federal authorities. NECC had received warning letters from the U.S. Food and Drug Administration.

    The pharmacy was also the subject of investigations by the Massachusetts pharmacy board. Those probes culminated in a 2006 consent agreement in which NECC agreed to rectify problems in its record-keeping and other procedures to escape more onerous sanctions.

    "In this administration, we're going to take a different tack," Patrick said. "No one should live in fear that their medicine is unsafe."

  • Fungal meningitis deaths now at 11; 119 cases confirmed

    The number of known patients has grown to more than 105 with eight deaths after tainted steroid injections were linked to a fast-growing meningitis outbreak. NBC's Tom Costello reports.

    JoNel Aleccia, Senior Writer, NBC News writes

    The number of people infected with a rare type of meningitis tied to contaminated steroid injections has climbed to 119, federal health officials said Tuesday. Eleven people have died. 

    The drugs were given starting May 21, much earlier than previously suspected, officials with the Centers for Disease Control and Prevention said. Infections and deaths have been reported in nine states. As many as 13,000 patients may have been exposed to the potentially contaminated drugs recalled from a Massachusetts compounding pharmacy, officials added. 

    Cases have been identified in 10 states and health officials fear the numbers will continue to rise as doctors check patients for the symptoms. Doctors and patients alike may not know to look for the unusual infection, which can take weeks to develop after an injection.

    New Jersey has now reported its first meningitis case that may be linked to the contaminated injections. Tennessee continues to log the most victims, with 35 cases and four deaths. In Virginia, 23 cases have been confirmed, with one death. Michigan has reported 21 cases and two deaths, while Maryland has reported five cases and one death. 

    Other affected states include Florida, with four cases; Indiana with 11 cases; Minnesota with three cases, North Carolina with two cases and Ohio with one case, officials said. 

    The drug in question is called methylprednisolone acetate and is used mostly to treat older patients for lower back pain.

    The contaminated drugs have been traced to the New England Compounding Center, a single compounding pharmacy. The pharmacy has closed voluntarily, relinquished its state license and recalled its products, which include steroids, painkillers and dozens of other drugs. At least one sealed vial of drug has been found to have fungus growing in it, the Food and Drug Administration said. The FDA does not regulate pharmacies like the one in Massachusetts but can be called in when contamination is suspected.

    Compounding pharmacies usually make drugs to order, and the steroids suspected of causing the infections did not contain preservatives that can keep fungi and bacteria from growing.

    The pharmacy sent products to clinics in 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, the CDC says.

    The patients appear to have had contaminated drugs injected directly into their spinal fluid. CDC says the clinics do not appear to be to blame. The CDC said it has found fungus, including Aspergillus and Exserohilum, in specimens from nine patients.

    In Tennessee, health workers contacted 66 patients who may have been infected, in some cases going door-to-door to inform them of the risk and to answer questions, state officials said. 

    Meningitis is an inflammation of the protective membranes covering the brain and spinal cord. Bacteria or viruses are the usual cause, but meningitis can also be caused by fungi and parasites. "In addition to typical meningitis symptoms, like headache, fever, nausea, and stiffness of the neck, people with fungal meningitis may also experience confusion, dizziness, and discomfort from bright lights. Patients might just have one or two of these symptoms," CDC said.

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  • Seven deaths reported in growing meningitis outbreak; second fungus found

    Maggie Fox, Senior Writer, NBC News writes

    Updated, Oct. 6: Federal health officials have widened their recall of drugs suspected of giving people an unusual type of meningitis that has so far killed seven, and identified two different types of fungus they believe are infecting people.

    At least 64 cases in nine states have been diagnosed with meningitis linked to the contaminated drugs, the Centers for Disease Control and Prevention reported Saturday.

    Health experts expect more cases will be reported and are asking anyone who had a recent steroid injection for lower back pain to be on the lookout for headaches, stiff necks, unsteadiness and other classic symptoms of meningitis.

    “All patients who may have received these medications need to be tracked down immediately. Patients can find the names of the clinics that used these medications on the CDC website,” said CDC's Dr. Benjamin Park, medical officer for the fungal diseases branch. “It is possible that if patients with infection are identified soon and put on appropriate antifungal therapy, lives may be saved.”

    Tennessee state health officials said four more people had been diagnosed there since Thursday, bringing that state’s total cases to 29, with three deaths. Michigan is the latest to report cases, with four there. People with suspected fungal meningitis have been diagnosed in Tennessee, Virginia, Maryland, Florida, North Carolina, Michigan and Indiana.

    The drug is question is called methylprednisone and is used mostly to treat older patients for lower back pain. All the cases so far have been traced to a single pharmacy in Massachusetts that makes the drugs to order. The pharmacy has closed, surrendered its license and recalled its products, Food and Drug Administration officials said. But they said hundreds of people could have been injected with contaminated steroids and possibly other products. The pharmacy could have shipped products to all 50 states.

    CDC listed the 75 clinics known to have received shipments of methylprednisolone from the pharmacy.

    Tennessee Health Commissioner Dr. John Dreyzehner said the clinics that treated the patients are not to blame. “Our continuing investigation found no lapses in process at the clinics,” Dreyzehner told reporters Friday. “Evidence indicates these clinics and clinicans had no way of knowing about the contamination.”

    "Fungus has been identified in specimens obtained from 9 patients, including Aspergillus and Exserohilum," CDC said. Both types of fungus are found in back yards --  Exserohilum can cause leaf spot but it's also been linked to skin and sinus infections. Aspergillus causes lung infections in cancer, HIV and other patients with suppressed immune systems.

    Some kind of fungal contaminant has been found in at least one vial of drugs made by the pharmacy. Fungi can grow in drugs that are not stored properly, especially those without preservatives, like those made by the compounding pharmacy.

    Meningitis is an inflammation of the spinal cord, usually caused by bacteria or viruses. It can be very serious and symptoms include headache, fever, often a stiff neck and balance problems. Fungi and parasites can also cause this inflammation and in this case the common mold aspergillus is suspected.

    Fungal infections are tricky to treat. Antifungal drugs including voriconazole and amphotericin can be used to treat the infections.

    "Currently, we think that this type of meningitis is quite severe as we have been describing here. The antifungal treatment for this is intravenous antifungal treatment and requires initial hospitalization. But the duration of antifungal therapy could be prolonged, possibly on the order of months," Park said.

    To be especially careful, health officials have widened their warning to anyone who got a steroid injection in the spine between July 1 and September 28 this year. “Infected patients have presented approximately 1 to 4 weeks following their injection with a variety of symptoms, including fever, new or worsening headache, nausea, and new neurological deficit (consistent with deep brain stroke),” the FDA said in a statement on its website.

    “Some of these patients’ symptoms were very mild in nature.”

    The FDA says there will be no shortage of methylprednisone. “There are FDA approved versions of methylprednisolone acetate injection on the market, available with or without preservatives,” it said.

    “Although all cases detected to date occurred after injections with products from these three lots, out of an abundance of caution, CDC and FDA recommend that healthcare professionals cease use of any product produced by the New England Compounding Center until further information is available,” the FDA added. Among the other drugs from the pharmacy being recalled are three steroid drugs -- betamethasone, a steroid usually given in creams or as a spray, dexamethasone and triamcinolone; two local anesthetics called lidocaine and bupivicaine; the blood pressure drug clonidine; and saline.

    Compounding pharmacies are not regulated as closely as drug manufacturers, and their products are not subject to FDA approval.

    Centers for Disease Control and Prevention

    List of healthcare facilities that received large amounts of methylprednisolone acetate (PF) recalled from New England Compounding Center on Sept, 26, 2012.

    The meningitis outbreak tied to steroid epidurals has killed five people so far, and originated from a specialty pharmacy in Massachusetts. NBC's Brian Williams reports.

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