Fungal Meningitis Outbreak

First case history shows fungal meningitis can destroy brain fast. She had a history of pain, the 51-year-old woman who showed up at a Maryland emergency room with a headache so bad it made her face hurt. Within 10 days she was dead, one of the first victims of an outbreak of fungal meningitis that has killed at least 20 people and made nearly 260 sick.

She was sent home after the first visit. Headaches are a common side-effect of any injection to the spinal cord. The ER staff did a CT scan to make sure she wasn’t having a stroke or perhaps suffering from a brain tumor and she was sent home again.

At least one consumer group says the Food and Drug Administration failed to act even though it knew of problems at the NECC. FDA and Massachusetts officials have both said they lacked the authority to move against the pharmacy and said Congress needs to pass clear legislation giving the FDA authority to regulate so-called compounding pharmacies.

Nine more people have been diagnosed with fungal disease linked to contaminated pain injections, federal health officials said Wednesday. They said 317 people had been sickened and 24 have died from the mold-contaminated drugs.

Of these, 312 had a rare form of meningitis that is not infectious to others but that causes very subtle symptoms and is hard to treat. They were infected by steroid shots into the spine. Five have been infected by injections to the ankle, knee, shoulder or elsewhere, the Centers for Disease Control and Prevention said.

As many as 14,000 people may have been given injections from three lots of steroid prepared by the New England Compounding Center in Framingham, Mass. State officials have revoked the company’s license and federal officials raided it earlier this month. Both state and federal officials say they found non-sterile conditions at the pharmacy and say it appears to have made and sold drugs far beyond what its license allowed.

CDC says 97 percent of the people who may have been affected have been told of the risk. They said the greatest risk of meningitis comes in the first six weeks after treatment; no one should have received any contaminated injections after Sept. 26, when the pharmacy’s drugs were recalled and officials first raised the alarm.

Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, called it an attempt to deflect criticism.

The FDA regulates drug manufacturers, and can inspect compounding pharmacies, which are supposed to make drugs for specific patients who need specific formulations on a prescription-by-prescription basis. NECC was one such compounding pharmacy.

She had a history of pain, the 51-year-old woman who showed up at a Maryland emergency room with a headache so bad it made her face hurt. Within 10 days she was dead, one of the first victims of an outbreak of fungal meningitis that has killed at least 20 people and made nearly 260 sick.

The case is the first to be described in medical detail, and shows that doctors need to act quickly if someone shows up with symptoms after having been given an injection that may have been contaminated with fungus.

She’d been treated for neck pain and a chronic condition called fibromyalgia that is defined by aches and pains all over the body and general weakness and fatigue. She had decided to try a new treatment, an injection in her neck of a steroid to help stop the pain there. It works in some patients – studies show it provides relief about half the time.

It should have been an in-and-out procedure. The steroid injections are considered very safe. The woman had no risk factors, Dr. Jennifer Lyons of the Howard Hughes Medical Institute and Johns Hopkins University in Baltimore reported. “She had not received injections previously, had no history of immune compromise or trauma, and was not taking any long-term medications,” they wrote in the report published in the Annals of Internal Medicine.

A week later, she developed the severe headache – so bad it drove her to the ER. Now, of course, doctors know that anyone who has had a steroid injection and shows up with symptoms like a severe headache should be checked for infection. But this woman was one of the first affected, before word got out.

But she was back the next day, suffering from double vision and nausea. She was dizzy and off-balance – all classic symptoms of meningitis. But she didn’t have a fever and her blood looked normal: no evidence of the immune system reaction seen when meningitis is caused by bacteria or viruses. An MRI didn’t show anything amiss.

All this time, the fungus must have been spreading through the patient’s brain and spine. (She hasn’t been identified in the report to protect her privacy and that of her family). State and federal investigators have found three different types of mold in samples of steroid taken from the New England Compounding Center in Massachusetts and from spinal fluid taken from some of the victims.

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