Oct. 4, 2012 at 10:32 AM ET
Health officials are working to track down everyone who may have been treated with an injection for lower back pain that is linked to an outbreak of rare fungal meningitis. So far, 35 people have been diagnosed with the infection in six states and five of them have died.
At least 75 clinics in 23 states received batches of the steroid drug from a Massachusetts compounding pharmacy and have been told to notify all affected patients, health officials said.
"Unfortunately, despite the current recall, we expect to see additional cases as this investigation unfolds. However, it is possible if patients are identified soon and started on appropriate antifungal therapy some of the unfortunate consequences may be averted," Dr. Benjamin Park of the U.S. Centers for Disease Control and Prevention told reporters in a telephone briefing.
Food and Drug Administration officials warned health care workers not to use any drugs from the New England Compounding Center in Framingham, Mass., which has voluntarily ceased distribution of all of its products.
The 35 cases include 25 people in Tennessee, one in North Carolina, two in Florida, three in Virginia, two in Maryland, and in Indiana, the CDC reported. Three of the deaths were in Tennessee, one in Virginia and one in Maryland.
"Infected patients have presented approximately one to four weeks following their injection with a variety of symptoms including fever, new or worsening headache, nausea and our new symptoms consistent with a stroke," Park said. "Some of these patients symptoms were very mild in nature. Cerebrospinal fluid obtained from these patients has shown findings consistent with meningitis. It is important to note that this type of meningitis is not transmissible from person-to-person."
Health officials are asking anyone who had a spinal injection for pain and who has symptoms such as a headache, stiff neck, dizziness or trouble walking to see a doctor right away.
The drug is question is called methylprednisone and is used mostly to treat older patients for lower back pain. Tennessee officials were the first to notice the unusual cases of meningitis, and discovered that the patients involved had all been treated at three specialty clinics. All had recieved direct injections of the steroid into their spines for pain. Women who received epidural infusions for childbirth are not in danger, the officials said.
Health officials have isolated aspergillus from five patients, CDC officials said. In addition, FDA officials detected fungal contamination in an unopened vial of methylprednisolone from one of three lots of 80-milligram injection doses recalled by the New England Compounding Center.
"Looking under microscopic examination, it was identified as a fungal contaminant. For the sake of time, because we -- everything is unraveling and unfolding very quickly, we have not been able to further microbial testing of additional vials and what is necessary. So, right now, we can only say that it is a foreign material," FDA's Dr. Ilisa Bernstein said.
Everything the pharmacy made is being checked. Berstein said it's not clear how many potentially contaminated vials of steroid were distributed. "But if they are licensed in 50 states, there is a possibility that it could be elsewhere, not just this product, but as well as other products that they have made," she said.
Meningitis is an inflammation of the spinal cord, usually caused by bacteria or viruses. It can be very serious and is marked by a headache, fever, often a stiff neck and balance problems. Fungi and parasites can also cause this inflammation and in this case the common mold aspergillus is suspected.
Aspergillus is tricky to treat. It’s an infection that patients with damaged immune systems can get – notably cancer patients and those with HIV infection. It’s often found in the lungs because the mold – found in dead leaves and elsewhere -- can be breathed in. An antifungal drug called voriconazole can treat the infection but the health officials said in this case they want to be sure before they try it. The side effects from the antifungal treatment can be severe and include kidney and liver damage.
"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.