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Pharmacy Fungus Plunges Doctors Into 'Gray Zone'

 |  By cclark@healthleadersmedia.com  
   November 13, 2012

Physicians trying to treat the hundreds of patients infected by black mold that that contaminated steroids distributed by a Massachusetts compounding pharmacy last month are finding a lack of evidence for what they should do first.

"We're basically in a gray zone," says Shmuel Shoham, MD, an internist and infectious disease specialist at Johns Hopkins University. "What makes this process difficult is that we're just now learning about the natural history of this infection."

Almost nothing is known about Exserohilum rostratum, the black mold or fungus implicated in the current outbreak in which an estimated 14,000 people have been exposed, with 438 patients infected so far in 19 states.

"Up until two months ago, when the first case was diagnosed, nobody had ever seen, in this location of the body, this particular type of infection in these types of patients," Shoham says. "And so what we've had to do is extrapolate data from other similar infections, organisms causing infections at another site, see how it behaves in the laboratory... and try to sort through to make a reasonable treatment plan."

Shoham and colleague, Kieren Marr, MD, director of transplant and oncology infections diseases at Johns Hopkins, published an article in the current online edition of the Annals of Internal Medicine.Itdetails what they've seen in several dozen infected patients treated at their hospital.

One of the major questions is what to do about patients who have been exposed to the contaminated steroid products but show no or only mild symptoms.

"Before administering preventive therapy, we must consider the potential adverse effects of both diagnostic evaluation and antifungal therapy," Shoham and Marr wrote, because both lumbar puncture and the current preferred drug regimens—voriconazol and amphotericin B—have numerous side effects, cross reactions with other drugs and over-the-counter products, and adverse reactions.

"While caring for patients potentially exposed to contaminated medication, we have seen symptomatic complications due to lumbar puncture, including symptoms related to changes in intracranial pressure and cerebrospinal fluid leaks," the wrote.

"The question has been asked, 'why don't we just give an antifungal to everybody that's been exposed, because this is such a catastrophic infection,'" Shoham says. "So we talk about the risks of the anti-fungal drugs that we have. Some of the 14,000 people exposed will never get an infection at all, maybe 98%. But about 2% have."

Shoham adds that the drug that seems most effective so far, voriconazol, "is a wonderful, wonderful drug that has saved many lives.  And I've seen it save lives myself.  However, it is a drug with substantial drug-drug interactions, and anytime anyone is prescribing it they must first look at everything the patient has been taking, even herbal medications and over-the-counter drugs they may pick up in non-traditional locations."

In another paper in the same issue of the Annals, infectious disease specialist Thomas Kerkering, MD, andclinicians at the Carilion Clinic in Roanoke, VA., describe their outcomes in treating half of the state's 50 infected, symptomatic patients, and the process they've used with all 131 patients who were exposed to contaminated epidural steroid injections, including some who have not become symptomatic to date.

Most worrisome, the researchers say, is that some of the patients who originally underwent lumbar punctures with no evidence of infection have later returned with meningitis caused by the steroid fungus.

This suggests "that patients will need to be followed for an undetermined duration of time."  Additionally, they say, a "high number" of patients have complained of "word searching," suggesting that long-term neurological consequences and central nervous system disease are important concerns for long-term follow-up, the researchers said in a statement.

This national outbreak of fungus or black mold from infected steroids injected into the spine is such a new issue, there still are no clear recommendations for the proper course of care, either for patients who are suspected of being infected or actually have symptoms, the researchers said.

Nevertheless, the hospital has established a hotline, and is treating patients with intravenous voriconazole, or in some cases intravenous amphotericin B if they developed voriconazole symptoms or side-effects.

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