Oct. 16, 2012 at 2:54 PM ET
Federal health officials have expanded their investigation of an outbreak of fungal meningitis, asking doctors to follow up with all patients treated with any products from a Massachusetts pharmacy. They said 233 people have been diagnosed with infections, and 15 of them have died, and federal agents raided the center on Tuesday.
Food and Drug Administration officials said an inspection of the New England Compounding Center raises concerns about its cleanliness procedures, and doctors need to reach out and make sure patients are all right. They want doctors to check not only people who got injections of steroids into their spines to treat pain, but patients treated with any product, from nipple cream to painkillers and steroids.
“We have looked at practices of the firm and we are concerned that we cannot provide assurances of sterility,” said the FDA’s Dr. Janet Woodcock. Woodcock said confidentiality concerns prevented her from giving details about what those practices might be.
“We are asking that clinicians who administered these products since the end of May actively contact their patients in some way,” Woodcock told doctors on a conference call. “We cannot assure right now that these products that were administered were sterile.” She says doctor's offices and clinics should call or write patients to ask about any symptoms they may have.
At first the outbreak only involved people treated with a steroid called methylprednisolone and only three specific lots of that drug made by NECC.
On Monday the FDA raised concerns about two more drugs -- a steroid called triamcinolone acetonide and another a product called cardioplegia used during heart surgery. At least three patients treated with those products have infections, although it's not certain they have fungal infections.
Woodcock said the FDA wasn’t sure how many patients might need follow-up from their doctors. Nearly 14,000 people got injections from three suspect lots of methylprednisolone, but the company shipped dozens of different drugs, many of them injectibles.
"We would like clinicians to report to us. We would like them to follow up with the patients and if there are any infections, we would like to hear about it," Woodcock said. "We know that NECC shipped large volumes of various products. We do not know how many."
A third mold called Cladosporium has now been found in a patient as well, said Dr. Tom Chiller of the Centers for Disease Control and Prevention. It is similar to Exserohilum, the mold most commonly found in patients with meningitis affected in the outbreak. CDC experts said it was possible other contaminants may be found, as well.
But the CDC still advises that only patients with clear signs of inflammation be treated with antifungal drugs. Patients who do need treatment likely face a minimum of three months of therapy, experts said.
Dr. Peter Pappas of the University of Alabama at Birmingham said doctors have never had to deal with anything like the current outbreak, and he said they are learning as they go along. "It’s not clear to me at all what is going to occur," he said on the conference call. Fungal infections can grow very slowly, and it could take a long time for infected patients to have any symptoms.
Two patients who were injected with steroid from NECC in the ankle have some kind of infection, CDC officials said. They are being counted among the 233 total victims because the infections are bacterial or viral in origin, so are presumed to be fungal. They're not in immediate danger in the same way meningitis patients are, but could also have to undergo months of antifungal therapy.
Some of NECC's products are creams or eye drops and the experts were reassuring about patients who may have used those, even if they turn out to have been contaminated. All three molds that have been identified are fairly common in the outdoors. "These are things we are exposed to every day in nature," he said. Most healthy patients who get them on the skin, in the eye or even who inhale them are not likely to become infected, he said. The biggest risk is to patients who had contaminated drugs injected into the spinal fluid.
The FDA and state regulators are checking to see how and why NECC shipped so many drugs to so many different places when it was supposed to be a compounding pharmacy -- one that makes drugs to order for individual patients. FDA had warned NECC several times both about sterility procedures and about doing business beyond its licensed permission.
Members of Congress say they are investigating the matter, as well. The House Energy and Commerce Committee has asked FDA, CDC and NECC officials to appear before a hearing by the end of the week. Members have also asked the Justice Department to investigate whether the NECC broke Drug Enforcement Administration regulations by selling morphine and other controlled substances.