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By Catholic Online (NEWS CONSORTIUM)

10/18/2012 (2 years ago)

Catholic Online (www.catholic.org)

Traced to steroid injections, officials work to recall tainted vials

Four more people have died in an outbreak of fungal meningitis infections. The infections have swept through several U.S. states, and have been traced to contaminated steroids used to treat back pain, often purchased without a prescription. To date, 247 people are now confirmed infected in 15 states.

Raiding NECC's facility in Massachusetts, the company that shipped the vials, FDA officials say that inspections of the facility made them worry about the sterility of any of the pharmacy's products.

Raiding NECC's facility in Massachusetts, the company that shipped the vials, FDA officials say that inspections of the facility made them worry about the sterility of any of the pharmacy's products.

Highlights

By Catholic Online (NEWS CONSORTIUM)

Catholic Online (www.catholic.org)

10/18/2012 (2 years ago)

Published in Health

Keywords: NECC, fungal meningitis, outbreak, spinal meningitis


LOS ANGELES, CA (Catholic Online) - Nineteen deaths from fungal infections have been reported in Tennessee, Virginia, Michigan, Maryland, Indiana and Florida, according to the Centers for Disease Control and Prevention.

Federal officials have opened an investigation into the Massachusetts pharmacy that distributed the suspected drugs. Doctors who treated any patients with any products from the pharmacy since last May have been asked to make sure all their patients are well. Based on how many drugs the New England Compounding Center made and distributed, it's feared that tens of thousands of people could eventually be affected.
 
"The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status," the Food and Drug Administration said in a statement.

"Symptoms for other possible infections may include fever; swelling, increasing pain, redness, warmth at injection site; visual changes, pain, redness or discharge from the eye; chest pain, or drainage from the surgical site (infection within the chest). Patients should contact their healthcare provider if they have any of these signs or symptoms."

Raiding NECC's facility in Massachusetts, the company that shipped the vials, FDA officials say that inspections of the facility made them worry about the sterility of any of the pharmacy's products.

Members of Congress are demanding answers but have not yet scheduled promised hearings. Massachusetts Rep. Ed Markey, a Democrat, noted that NECC distributed controlled substances including morphine and fentanyl without a proper license.

"The list of recalled NECC drug products appears to include nearly 1,000 formulations that contain controlled substances that fall under the jurisdiction of the Drug Enforcement Agency (DEA)," Markey said in a statement.

In an alarming statistic, NECC shipped more than 17,000 vials from the three suspect lots of steroid to clinics in 24 states.

FDA and Massachusetts officials have said they didn't have enough powers to stop the pharmacy, which was not licensed to mass-produce drugs. They both asked Congress to pass legislation clarifying their powers.

Most of those sickened so far were injected with steroids from three particular lots made by NECC. The sickest patients developed meningitis, an inflammation of the protective membranes or meninges, covering the brain and spinal cord. The swelling is usually caused by bacteria or viruses, but meningitis can also be caused by a fungus. Most of those who died suffered strokes.

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