Drug scare raises alert level in NH
Vials of the steroid distributed by New England Compounding Center (NECC) - implicated in a meningitis outbreak - are pictured in this undated handout photo obtained by Reuters. (REUTERS)
Thousands of patients across New Hampshire have been notified by their doctors that they received injections of drugs made by a Massachusetts company under federal investigation for a deadly outbreak of fungal meningitis.
The outbreak, which as of Saturday has sickened 344 people in 18 states and resulted in 25 deaths, has been linked to three lots of an injectable steroid produced by New England Compounding Center.
And while public health officials here say there is no proof yet that other drugs made by the Framingham, Mass., company were tainted, they are advising patients who got any kind of injectable medications shipped by NECC since May 21 to watch for signs of illness.
“It's really to err on the side of caution and make sure we're not missing anyone,” state epidemiologist Dr. Sharon Alroy-Preis told the New Hampshire Sunday News.
“We don't want to falsely reassure people, but we don't have proof that other products have been contaminated,” she said. “We just want people to be careful and to monitor their symptoms.”
Alroy-Preis said there are patients in other states “who received other products and have been ill with fungal infections.”
“It's not clear if they're sick because of the products or they're sick because of other reasons,” she said.
As of Friday, 11 patients in New Hampshire had been diagnosed with illnesses associated with the outbreak. Eight have fungal meningitis; the other three have other fungal infections, according to the state health department.
Public health officials here are closely following those patients, Alroy-Preis said. “The right people are on therapy, they're all being followed by infectious-disease specialists, and we are taking this very, very seriously,” she said.
The Division of Public Health Services last week released a list of 24 medical providers that received injectable medications shipped by NECC since May 21. The division asked providers to report how many of their patients received injections of those drugs.
Ten hospitals are on the list: Alice Peck Day in Lebanon; Cheshire Medical Center in Keene; Concord; Elliot Hospital at River's Edge; Exeter; Lakes Region General in Laconia; Monadnock Community in Peterborough; Portsmouth Regional; Speare Memorial in Plymouth and Wentworth-Douglass in Dover. So are pain clinics, eye doctors and surgery centers.
The Food and Drug Administration put out its own list of facilities that got shipments from NECC since May, including 32 in New Hampshire.
But Dr. Jose Montero, the state's public health director, said the focus here is on the 24 providers that received injectable medications, since the fungal infections reported to date have all been associated with injections. The other eight providers received only topical medications, and Montero said there appears to be no risk associated with such drugs.
On Oct. 4, the FDA advised medical providers that all products produced by NECC should be “retained, secured, and withheld from use.” Two days later, NECC announced a “voluntary” recall of all products compounded and distributed by its plant.
Montero urged patients who have concerns to contact their primary care physicians.
“The problem is, we cannot really tell them what the real level of risk is,” he said. “That's why our message is: Keep in touch with your physician, be aware of possible symptoms that may relate to this, and report anything that comes that is unusual and discuss it with your clinician, and we'll go from there.”
Symptoms of fungal meningitis can be initially mild, and may include headache, fever, nausea, stiff neck, confusion, dizziness and discomfort from bright lights. The illness is not transmitted from person to person, according to the state health department.
This type of fungal infection has never been documented in humans before, Montero said, so it's difficult to say when patients are in the clear. “The medical science ... doesn't really know how this disease evolves and behaves, and that makes treatment equally complex because we've never had it before,” he said.
Joseph Conley, Concord Hospital's chief operating officer, said it's not clear why the FDA wants providers to contact their patients who received any injectable drugs from NECC.
“The FDA's taken a big, broad brush at this,” he said. “We have no other evidence of concern, so it's hard to know really what's going on.”
Concord Hospital has sent letters to 60 patients who received two kinds of injectable medications made by NECC: “sulphan blue,” a dye used in surgery to highlight an area, and etomidate, an anesthetic used in intubation. The hospital had removed all NECC drugs from its pharmacy as soon as the outbreak was reported, Conley said.
Conley said the fact that none of those 60 patients is ill may indicate the danger has passed. “If there were going to be infections in these people, we'd have seen them by now,” he said.
Still, he said, the lack of information from the FDA has been “a little frustrating.”
“We think we're doing due diligence,” he said. “We've contacted the patients; we're monitoring them effectively. We have no reason to doubt we're doing everything we're supposed to do, but it would be nice to know: Just exactly what are you guys finding?”
According to an FDA report released Friday, inspectors who visited the NECC facility on Oct. 2 found 83 vials of methylprednisolone acetate — the drug implicated in the outbreak so far — that contained “what appeared to be greenish black foreign matter.” Seventeen vials from the same bin contained “what appeared to be white filamentous material.”
The report states that lab analysis confirmed the presence of “viable microbial growth” in 50 out of 50 vials tested; one vial “showed fungal morphological features.”
The report also detailed “greenish yellow discoloration,” “white filamentous substances,” and yellow and green “residue” on many surfaces at the lab.
Officials say they share Conley's frustration about the lack of scientific data available about other NECC drugs.
“I think the biggest problem at the moment is it's not really clear where the risk is,” said Alroy-Preis. “So once the risk is clarified, which products were contaminated or not, and we have a handle on what universe of patients were exposed to those contaminated medications, then we may be able to see the down of the slope.”
Meanwhile, she said, “It is very difficult to work in this data-free zone of what's happening with other products.”
The list of medical providers that received medications shipped by NECC since May, and a list of those drugs, are available at fda.gov. Any patient with concerns about the ongoing fungal meningitis outbreak can call the Division of Public Health at 271-6617 (during business hours).
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