Meningitis investigation: Are other drugs involved?
Warnings have been issued for every injectable drug distributed by a Massachusetts firm that sold contaminated medications blamed for 15 deaths and more than 200 likely cases of fungal meningitis — including at least three cases in New Hampshire.
A new case of fungal meningitis has now been linked to a second drug made by the New England Compounding Center (NECC) of Framingham, Mass.
“They are saying that, through surveillance systems going on around the initial cases, other cases may have come to their attention that may be linked to a second product,” said Dr. Jose Montero, the state's public health director.
In addition, a fungus believed to cause meningitis has been found in heart transplant recipients treated with yet another NECC drug.
The FDA said Monday it now has “significant concern” about the sterility of all injectable drugs produced by the New England Compounding Center.
In addition, the FDA warning about NECC drugs is also extended to non-injectable drugs used in conjunction with eye surgery. No patients have been reported to have been infected during eye surgery, but the FDA said the type of product used “poses similar risks of infection.”
Previously, only a single NECC product, the steroid methylprednisolone acetate, was implicated in the meningitis outbreak.
The newest case of suspected fungal meningitis involves the product triamcinolone acetonide, which is also an injectable steroid made by NECC.
The two heart transplant patients were infected with Aspergillus fumigatus, one of two fungi suspected of causing the meningitis outbreak. Each patient received an injectable drug made by NECC while undergoing the transplant.
The drug used is known as a cardioplegic solution, which is used to protect the heart during transplant surgery.
The FDA said it has not confirmed that the three infections were caused by NECC products, and said it issued the warning out of “an abundance of caution.”
Patients who received products sold or produced by NECC after May 21 “should be warned of the potential risk of infection,” the agency said. However no direct patient follow-up has been urged for patients who received lotions, creams, or eye drops not used during surgery. “Products such as lotions and cremes and eye drops are not a concern,” Montero said. “The reason for concern is (putting) contaminated product in a place in the body that is sterile.”
Complicating the newest warning was an immediate shortage of information about distribution of the NECC inventory of drugs, including precisely where the medicine was sent.
“There is no information whatsoever; we don't know how many sites or how many patients may be affected or impacted by what the FDA said,” Montero said. “This is expanding and we don't know how much more it may be.”
A listing of drugs distributed by NECC released by the FDA runs 71 pages.
The federal Centers for Disease Control and Prevention initially said that four New Hampshire patients were considered likely to have contracted meningitis from a NECC injection. The agency now says three have signs of meningitis and the other patient suffered an infection as the result of an injection into a joint.
Only one other case of a joint infection had been reported prior to the New Hampshire case.
Uncertainty over the extent of the crisis is troubling to both patients and physicians.
Lisa, a New Hampshire woman who did not want her last name published, said she had a “trigger point” injection of the suspected NECC steroid for joint pain.
“They say a symptom (of meningitis) is a stiff neck but you have a stiff neck from the shot anyway,” Lisa said. “I get migraine headaches, but headaches are a symptom; you just can't tell.”
The expansion of the warning to everything NECC distributes is making things more difficult for physicians and regulators.
“It is a huge concern for anybody who cares about health care quality and for anybody who cares about our patients,” Montero said. “The last thing you want is someone going to a health care professional and coming out with something else.”
The New Hampshire Board of Pharmacy meets Wednesday to take up suspension of NECC's license to distribute drugs in the state. NECC has voluntarily surrendered its pharmacy license in Massachusetts and had been surrendering its distribution license in other jurisdictions, but a formal board vote is needed to accept the surrender.
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