Concern is quickly mounting over the rapidly escalating toll from a widespread meningitis outbreak related to spinal injections for back pain. The scope of the problem—at least 11 deaths and as many as 13,000 people exposed to a pathogen that causes meningitis via lumbar epidural injections—is stunning and terrifying to both ordinary citizens and pain physicians alike.
Products Recalled, Source Still Not Definitively Identified
On Sept. 18, the Tennessee Department of Health was notified of a patient with culture-confirmed aspergillus meningitis following a lumbar epidural injection with compounded methylprednisolone acetate at the Saint Thomas Outpatient Neurosurgical Center in Nashville. Consequently, the Saint Thomas clinic voluntarily closed on Sept. 20; the next day, the state’s Department of Health informed the Centers for Disease Control and Prevention (CDC) about the meningitis case, even though fungal meningitis is not a reportable condition. On October 10, a second fungus, exserohilum, was confirmed to be the primary source of the infections.
On Sept. 25, the New England Compounding Center (NECC), the company that supplies compounded, preservative-free, methylprednisolone acetate (80 mg/mL) to dozens of clinics across the country, voluntarily recalled three lots of the drug. Thousands of vials from these lots had been shipped to about 75 clinics in 23 states in May. Before the recall, as many as 13,000 people received injections that included drugs from this lot.
Then on Oct. 3, NECC shut down all production and initiated a recall of the methylprednisolone and other drugs it had compounded for intrathecal administration. An Oct. 4 statement from the company noted that, “We also understand the FDA—as a precautionary measure—has suggested to medical professionals that they do not use any NECC products at this time, although there is no indication of any potential issues with other products.” The only information now available on NECC’s website (www.neccrx.com) addresses the nationwide product recall.
Although the majority of patients who received injections from the recalled lots of methylprednisolone have been contacted and are not ill, as of Oct. 9, 119 cases of meningitis had been identified in Tennessee, North Carolina, Florida, Virginia, Indiana, Michigan, Minnesota, Maryland and Ohio. A total of 11 people have died (http://www.cdc.gov/hai/outbreaks/meningitis-map.html)
The CDC has issued a Health Advisory on the outbreak (http://emergency.cdc.gov/HAN/han00327.asp), as well as information on diagnostic testing that should be performed on patients suspected of having contracted meningitis (http://www.cdc.gov/hai/pdfs/outbreaks/Outbreak-diagnostic-protocol-cleared.pdf) and treatment options for confirmed cases (http://www.cdc.gov/hai/pdfs/outbreaks/Treatment-Options-10-3-2012-cleared.pdf).
An official with the CDC said in an Oct. 4 news conference that fungus had been identified in five of the 35 people in six states who had shown clinical signs of meningitis.
“While investigation into the exact source of these infections is ongoing, all infected patients received preservative-free methylprednisolone acetate from among the three lots voluntarily recalled by the New England Compounding Center,” said Benjamin Park, MD, medical officer at the CDC’s Mycotic Diseases Branch. “While CDC is only aware of infections occurring in patients who have received epidural steroid injections, patients who received other type of injections of methylprednisolone acetate from those three lots should be tested for signs of infection.”
The FDA found “fungal contamination by direct microscopic examination of particulate matter taken from a sealed vial of methylprednisolone acetate collected from NECC,” said Ilisa Bernstein from the FDA’s Office of Compliance at the same news conference.
Tests are under way to identify the fungus, and hence officials from the CDC and FDA could not yet confirm that it is the source of the meningitis outbreak. However, as a precaution the FDA is advising all health care practitioners not to use any product from the NECC until the investigation into the source of the outbreak is complete.
Reactions From Pain Physicians
In the wake of the meningitis outbreak, pain medicine physicians are unanimously defending spine injections.
David Solsberg, MD, who works in private practice in Colorado, said, “sporadic contamination of medication rarely occurs in the U.S.A. ... The exact origin of the contamination is not yet known and it is premature to blame the manufacturer. It might be from the compound or the packaging.”
The website of one of the major interventional pain organizations, the International Spine Interventional Society (ISIS), stated that the organization is concerned with the affected patients and their families—and “this also a tragedy for the providers who obtained medications from a large and reputable source and now are a direct part of this horrific outbreak. Steroid injections are safe. [Millions] are administered every year and countless numbers of patients obtain relief as a result. The number of patients who develop severe complications as a result is incredibly low. The incidence of infection is thought to be less than 1:100,000. Death is extremely rare.”
The American Academy of Pain Medicine also issued a statement on the meningitis outbreak, urging anyone who has been treated with a spinal injection for back pain in the past month to contact the facility where they received the injection (Box).
Ray M. Baker, MD, president of ISIS and a past president of the North American Spine Society, explained why, pain physicians use products from compounding pharmacies such as NECC rather than directly from pharmaceutical manufacturers.
“Providers had an ample supply of reasonably sized and priced single-dose vials of methylprednisolone; however, the commonly manufactured preparation contained preservatives. Seeking to reduce the risk for a complication related to preservatives in or around the spinal nerves or cord, these providers obtained preservative-free methylprednisolone from NECC. This specific preparation is not available from major manufacturers,” he toldPain Medicine News.
—Rosemary Frei, MSc
Drs. Solsberg and Baker do not have any relevant conflicts of interest to disclose.
Statement from the American Academy of Pain Medicine
In light of the meningitis outbreak that is now threatening 23 states, the physicians of the American Academy of Pain Medicine (AAPM) echo the advice of the U.S. Centers for Disease Control and Prevention (CDC) and the FDA and urge anyone who has been treated with spinal injections for back pain within the past 4 weeks to contact their health provider if they begin having new or worsening symptoms, such as fever, new or worsening headache, nausea, or new neurologic difficulties. They also encourage patients to return calls that they might receive from the physician, hospital or clinic where they received their injections.
“Communications between physicians and patients are vital in the effort to prevent further outbreak,” said Martin Grabois, MD, president of the AAPM.
“We urge patients who have received these treatments to err on the side of caution if they have new or worsening symptoms since their injection. They should contact the medical expert, health clinic or hospital where they received their injection, even if the symptoms are very mild in nature,” Dr. Grabois added.
“These steroid injection treatments are helpful and have offered hope and relief for many people with pain, but as with any medical procedure there are risks involved. We are thankful for the efforts of the CDC and FDA to make all health professionals and the public aware of the situation and to a rapid response across the health provider community that is sure to save lives,” Dr. Grabois said. “As physicians, our hearts grieve for those who are and have been affected by this situation and as the leading organization for multimodal, multidisciplinary pain medicine, we seek to do all we can to support this effort.”