Published Date: 2012-10-07 12:01:52
Subject: PRO/EDR> Aspergillus meningitis - USA (04): more cases, 2nd fungus
Archive Number: 20121007.1328893
ASPERGILLUS MENINGITIS - USA (04): MORE CASES, SECOND FUNGUS
A ProMED-mail post
ProMED-mail is a program of the
International Society for Infectious Diseases
Date: Sat 6 Oct 2012
Source: NBC News [edited]
Federal health officials have widened their recall of drugs suspected of giving people an unusual type of meningitis that has, so far, killed 7, and identified 2 different types of fungus they believe are infecting people. At least 64 cases in 9 states have been diagnosed with meningitis linked to the contaminated drugs, the CDC reported Sat 6 Oct 2012. 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 neck, 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 4 more people had been diagnosed there since Thu 4 Oct 2012, bringing that state's total cases to 29, with 3 deaths. Michigan is the latest to report cases, with 4 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, FDA 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 on Fri 5 Oct 2012. "Evidence indicates these clinics and clinicians 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 has 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.
"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 1 Jul and 28 Sep 2012. "Infected patients have presented approximately 1-4 weeks following their injection with a variety of symptoms, including fever, new or worsening headache, nausea, and new neurological deficits (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 3 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 3 steroid drugs, betamethasone, a steroid usually given in creams or as a spray, dexamethasone and triamcinolone; 2 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.
[Byline: Maggie Fox]
[As the number of cases continues to frighteningly rise, a 2nd mold, _Exserohilum_, has been reported to be involved. This environmental organism is much less common as a human pathogen than _Aspergillus_. This agent is one of the molds associated with phaeohyphomycosis (McGinnis MR, Rinaldi MG, Winn RE: Emerging agents of phaeohyphomycosis: Pathogenic species of Bipolaris and Exserohilum. J Clin Microbiol. 1986;24:250-259).
The health care facilities to which the product had been distributed can be found on a list at: http://www.cdc.gov/hai/outbreaks/meningitis-facilities-map.html.
An excellent, long overview, including a discussion on the role of compounding pharmacies, can be found at: http://www.nytimes.com/2012/10/07/us/scant-drug-maker-oversight-in-meningitis-cases.html.
A HealthMap/ProMED-mail map can be accessed at: http://healthmap.org/r/1hiS. - Mod.LL]