The growing outbreak of fungal meningitis has led some people to question the widespread use of epidural steroid injections for pain. Steroids contaminated with a fungus are suspected of transmitting the infection.
Patients who have developed this rare form of meningitis, an inflammation of the lining of the brain, have received steroid injections from a Framingham, Mass., specialty pharmacy, according to the Centers for Disease Control and Prevention.
By Tuesday, the outbreak had grown to 119 patients in 10 states, with 11 deaths. CDC officials say many more could be infected.
That's because 13,000 patients were treated with three recalled lots of steroids, CDC spokesman Curtis Allen says. While most of those patients received epidural injections for lower back pain, some patients may have been injected in the knee or other areas. Knee injections typically don't lead to meningitis, but could cause a more limited infection in the joint itself. Contaminated epidural injections, however, which are given near the spine, can lead to meningitis, because the spinal fluid provides an express route to the brain.
Rep. Edward Markey, D-Mass., said Tuesday that he will introduce legislation to strengthen the Food and Drug Administration's oversight of compounding pharmacies because of the meningitis outbreak.
CDC officials say that anyone who had an epidural injection since May 21 should contact their doctor if they have symptoms such as a new or worsening headache, fever, stiff neck, sensitivity to light, slurred speech or newly developed weakness in any part of the body. Not all patients who received the injections will become sick. As a precaution, doctors can give exposed patients anti-fungal medications, CDC officials said.
Among patients who have become ill, symptoms have developed between one to four weeks after receiving the injections.
Sue Manor, 66, of Hendersonville, Tenn., at first cracked jokes after discovering she had received one of the recalled steroid injections. But a couple of nights later, anxiety set in, and she packed a bag for a trip to the hospital — even though she never went. "I had a couple of days where I had a headache and my neck was stiff," Manor said. "Intellectually, I knew it was stress bringing it on. But there is the slightest possibility — or even a good possibility — that it could be the early onset of meningitis on my system."
The outbreak is already interrupting medical care for some patients.
Anders Cohen, chief of neurosurgery and spine surgery at the Brooklyn Hospital Center in New York, said he advises patients in pain to wait until the CDC's investigation is completed before getting steroid injections.
Steroid injections are an "extremely common" treatment for lower back pain, such as sciatica caused by a herniated disk, said William Blau, a professor of anesthesiology at the University of North Carolina's School of Medicine. "I'm guessing there are hundreds or thousands every day," he said.
Steroids decrease inflammation, which can ease pain. Injections are a mainstay of pain management, used for decades. They're a good alternative to narcotics for people with chronic pain, because they are very safe, effective and pose no risk of addiction, said David Zvara, chair of anesthesiology at UNC-Chapel Hill.
The risk of complications is a fraction of 1%, Blau said. "We give about three injections a day, and we're just one clinic." Blau says that people with long-term pain may need two or three injections a year.
Steroid injections "dramatically and immediately decrease inflammation around irritated nerve roots," Zvara said. "Getting an injection like this hastens the healing process and can mean the difference between several lost days of work with back pain and returning to normal functioning within a day or two for many people."
Pain specialists can help people decide if an injection is the best therapy, Zvara said.
"In most cases, an irritated nerve root will heal on its own over several days or weeks, he said. "The steroid injection hastens this process dramatically. For some, back pain can be debilitating, resulting in lost work and suffering. Seeing a physician and potentially receiving a steroid injection in conjunction with other analgesics and muscle relaxants can be enormously beneficial," Zvara said.
"Importantly, patients must determine if the back pain is due to a surgical problem such as a herniated disc or a tumor as the steroid injection may reduce some of the discomfort, but it will not reverse the underlying cause."
Epidural steroid injections are administered somewhat like the epidural pain relievers given to many women in labor, injected at the base of the spine near the spinal fluid, Blau said. Women in labor, however, receive continuous pain relief through a catheter, rather than a one-time steroid shot.
In some ways, epidurals have advantages over taking steroid pills. Because they're shot directly into the spinal area, they tend to cause fewer side effects than oral medications, which circulate throughout the body. Some of the main side effects from long-term steroid use are immune suppression and a worsening of osteoporosis, which can increase the risk of bone fractures, Blau said. The tainted steroids "are such a potential health hazard for patients because the medication is site specific, delivered to the spinal canal, and nerves in the spinal cord," Cohen said.
He said patients who choose to skip epidural medications for now "can ask their physicians about other alternatives such as oral pain medications. I advise patients to call their physicians to make sure their lots are cleared."
Cohen said the outbreak highlights stress in the pharmaceutical industry, which sometimes can't produce enough of certain medications.
"Due to the high demand of certain medications, pharmaceutical companies are outsourcing production, which sometimes leads to problems, because compounders are not under the same stringent regulatory guidelines as the pharmaceutical companies," Cohen said.
While the Food and Drug Administration inspects factories, it doesn't inspect compounding pharmacies, where pharmacists typically mix up individual prescriptions for specific patients, said William Schaffner, an infectious disease expert at the Vanderbilt University School of Medicine in Nashville.
Companies may turn to compounding pharmacies for help, partly because these facilities can sometimes make cheaper products, Schaffner said.
Compounders also will sometimes take a large amount of medication and break it up into smaller unit, so that it can be given to more patients, he says. Licensed pharmacists can make their own compounds, and they are typically regulated by state pharmacy boards, Schaffner said.
But these boards police the behavior of individual pharmacists, and don't conduct inspections of manufacturing facilities. The meningitis outbreak has put a spotlight on the issue, Schaffner said.
He said patients typically have no way to know where their medication comes from or how it's made.
"I don't think that any patients receiving medicine for any reason has ever asked, 'Where did you get that medication?' " Schaffner said. "They expect the medication will be safe. That is a reasonable expectation."