Steroid Meningitis Outbreak Victims Could Reach 13,000

Steroid meningitis outbreak victims could reach 13,000 say federal officials. It is believed that as many as 13,000 people received steroid shots suspected in a national meningitis outbreak.

Steroid Meningitis Risk Highest With Back Injections

It is unclear how many of the 13,000 will develop deadly meningitis. Officials do not know how many of the shots were actually contaminated with the meningitis-causing fungus, and they don’t know as of yet how many actually got them in the back for pain — who are most at risk — but also those who got the shots in other places, like knees and shoulders.

Meningitis Is Deadly!

Meningitis is an inflammation of the lining of the brain and spinal cord, and a back injection would put any contaminant in more direct contact with that lining.

Symptoms on meningitis include severe headache, nausea, dizziness and fever. The CDC said many of the cases have been mild and some people had strokes. Symptoms have been appearing between one and four weeks after patients got the shots.

The number of people sickened in the outbreak has reached 105 as of Monday, October 08, 2012. The death toll has risen to eight, with another fatality in Tennessee, the CDC has just confirmed. Tennessee has the most cases, followed by Michigan, Virginia, Indiana, Florida, Maryland, Minnesota, North Carolina and Ohio.

Investigators suspect a steroid medication made by a specialty pharmacy may be to blame. About 17,700 single-dose vials of the steroid were sent to 23 states. Inspectors found at least one sealed vial contaminated with fungus, and tests were being done on other vials.

The steroid is known as preservative-free methylprednisolone acetate, which the compounding pharmacy creates by combining a powder with a liquid.

Fungal Meningitis Is Rare And Deadly

The first known case of the rarely seen fungal meningitis was diagnosed last month in Tennessee. The steroid maker, New England Compounding Center of Framingham, Mass., recalled the drug, and over the weekend recalled everything else it makes.

“While there is no indication at this time of any contamination in other NECC products, this recall is being taken as a precautionary measure,” the company said in a statement.

Doctors should contact any patient who got doses from any of the recalled lots, and should look back at their records as far back as mid-May, CDC officials say.

Lack Of Regulations Maybe To Blame

According to The New York Times, some doctors and clinics have turned away from major drug manufacturers and have taken their business to so-called compounding pharmacies, like New England Compounding, which mix up batches of drugs on their own, often for much lower prices than major manufacturers charge — and with little of the federal oversight of drug safety and quality that is routine for the big companies.

The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts

Kevin Outterson, an associate professor of law at Boston University.

As state and federal authorities pored over information about New England Compounding last week, there was little agreement among experts on whether the company broke the law by making products in bulk and shipping them around the country.

Compounding Pharmacies = Legal No Man’s Land

Compounding falls in a legal no man’s land, between the federal government and the states. The FDA regulates manufacturers, but compounders register as pharmacies, putting them under a patchwork of state rules. The FDA did develop a clear set of rules for compounding, but subsequent litigation that culminated in a Supreme Court decision in 2002 struck them down, and Congress never re-established the agency’s clear authority, Professor Outterson said.