Meningitis Cases Spark Call for FDA Oversight

USA Today

October 11, 2012

Two members of Congress are proposing legislation to improve patient safety in the wake of a widening meningitis outbreak that has infected at least 119 people and killed 12.

Florida’s health department reported that state’s first death Tuesday. Victims also have died in four other states: six in Tennessee, three in Michigan, and one each in Maryland and Virginia. Many more could potentially be infected.

That’s because 13,000 patients were treated with three recalled lots of steroids, Centers for Disease Control and Prevention spokesman Curtis Allen said. The CDC has tied the rare fungal meningitis outbreak to steroid pain shots.

While most of those patients received epidural injections for lower back pain, some patients may have been injected in the knee or other areas, Allen said. The steroids, which were recalled Sept. 26, were made by New England Compounding Center, a specialty pharmacy in Framingham, MA.

Reps. Ed Markey (D-Mass.) and Rosa DeLauro (D-Conn.) said Tuesday in separate statements they will introduce legislation to strengthen the Food and Drug Administration’s oversight of compounding pharmacies.

At least one contaminated vial was found at the Massachusetts company, which has since recalled all of its products. Pharmacy “compounding” often involves making a new drug whose safety and efficacy haven’t been demonstrated with the data the FDA ordinarily would require in reviewing a new drug application, according to Markey’s office.

About 75 facilities in 23 states received the recalled doses. The disease is not transmitted from person to person. The CDC has urged doctors to contact patients who received potentially contaminated injections as early as May 21. Giving anti-fungal drugs to exposed patients could prevent complications and save lives.

Meningitis is an inflammation of the lining of the brain and spinal cord. Infected patients have developed headaches, stiff neck, fever and other symptoms, which have set in one to four weeks after their injections. Sue Manor, 66, of Hendersonville, TN, received one of the recalled steroid injections and has packed a bag for a trip to the hospital in case it’s needed.

“I had a couple of days where I had a headache and my neck was stiff,” she 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.”