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Entries in Steroid (4)

Friday
May312013

CDC Opens Multi-State Investigation of Infections After Steroid Injections

iStockphoto/Thinkstock(NEW YORK) -- The Centers for Disease Control and Prevention is investigating steroid products produced by a Tennessee pharmacy after a number of patients who received them developed skin and soft tissue infections.

So far, the CDC acknowledges 20 reports of people who received the preservative-free form of the steroid methylprednisolone acetate (MPA) produced by the Main Street Family Pharmacy in Newbern, Tenn., who have contracted infections. So far, the known infections have been reported in Florida, Illinois and North Carolina. However, according to pharmacy records, similar products were shipped to facilities in 17 states since December 2012.

The products in question are the same as those that were implicated in fungal meningitis infections that were reported in previous months.  However, the prior meningitis infections were linked to products shipped from an unrelated compound in Massachusetts.

The products have been recalled by the pharmacy. As of now there have been no reported cases of meningitis linked to MPA products from the Main Street Family Pharmacy, and none of the reported infections are considered life-threatening.

There was no information available regarding infections caused by products other than the preservative-free MPA. State and local health departments are also working with the CDC and the FDA on the ongoing investigation.

Copyright 2013 ABC News Radio

Thursday
Oct252012

Epidural Steroid Injection Risks Include Incurable Arachnoiditis

iStockphoto/Thinkstock(NEW YORK) -- Helen Bertelli, a mother of two young girls from Raleigh, N.C., has been crippled with weird symptoms -- electric shocks, muscle cramps and the sensation that water is running down her legs -- all since she received an epidural steroid injection for back pain in 2011.

Three months after a medical "fellow" administered the shot at a pain clinic, she had trouble urinating, then both her feet went numb.

"I had this feeling I was connected to the end of a guitar string and someone was plucking it," said Bertelli, 36, a former runner and hiker.  "My legs just exploded like there were fireworks in them.  My muscles twitched like they were boiling."

For months doctors told her the knife-like pains were in her head, but six months later, Bertelli was diagnosed with arachnoiditis, an incurable condition that can be associated with epidural steroid injections.

Arachnoiditis is not fungal meningitis.  The outbreak that killed 23 and infected 308 patients nationwide was linked to contaminated steroid solution prepared by a Massachusetts compounding pharmacy.

What Bertelli has is a pain disorder caused by the inflammation of the arachnoid, a delicate spider web-like membrane that surrounds and protects the spinal nerves, spinal cord and brain.  The three most common causes are surgery, infection and chemical irritation.

"It's rare," said Dr. Ray M. Baker, an anesthesiologist and president of the International Spine Intervention Society.

But advocates, including Baker, say that the rising number of epidural steroid injections -- many performed by untrained clinicians -- signals the need for better medical and patient education about risks.

There is some evidence linking the preservatives in steroid medication to arachnoiditis, when the medication is accidentally injected into the spinal fluid.  Fluoroscopic (x-ray) guidance is useful with spinal injections, as it confirms needle placement outside of the spinal fluid and allows for safe injection, according to Baker.

"With the right hands, the right skill set and the right patient and the right conditions, they are safe and quite effective," said Baker.  "We don't have a lot of policing or oversight to say what are the standards and the rules."

And consumers don't know what a "quality job" is, he said.

"Although the fungal meningitis outbreak is a horrible tragedy, we need to be looking at lessons learned," he told ABC News.  "If any good can come from this, in addition to shining a light on the need for greater oversight of compounding pharmacies, it might be that the media attention on steroid injections will allow patients to become better-informed consumers.  For patients, it is buyer beware."

A patient group, led by Bertelli, has urged the Food and Drug Administration (FDA) to provide more comprehensive training of the practice, better oversight of physicians and better patient consent forms that include arachnoiditis as a potential complication.

She also wants better tracking of adverse events and better guidelines for doctors on contraindications.

FDA spokesman Sandy Walsh said "the practice of medicine" does not fall under FDA regulation, but is regulated by the states.

"That being said, in a broader sense, FDA does review adverse event reports and notify the public of safety warnings as we learn new information," she told ABC News.  "And we do often work with physicians groups and external partners."

She acknowledged that complications from these epidural injections can include, in addition to arachnoiditis, bowel and bladder dysfunction, headache, meningitis, paraparesis/paraplegia, seizures and sensory disturbances.

Copyright 2012 ABC News Radio

Friday
Oct122012

Meningitis Outbreak: Minnesota Woman Sues Pharmacy

Jared Wickerham/Getty Images(SHAKOPEE, Minn.) -- A Minnesota woman is the first person to sue the compounding pharmacy at the center of a fungal meningitis outbreak that has claimed 14 lives.

In a class action filed Thursday in U.S. District Court, Barbe Puro of Shakopee, Minn., claimed she developed symptoms of meningitis after receiving a spinal injection of methylprednisolone acetate tainted with fungus.

The drug, a steroid used to treat back and joint pain, was made by the New England Compounding Center in Framingham, Mass. Fifty sealed vials of the drug, obtained by the U.S. Food and Drug Administration, were found to contain fungus. The company has recalled all its products and shut down operations.

Calls to the compounding pharmacy were not immediately returned, and its website is down.

Puro is one of roughly 14,000 people believed to have been exposed to the suspect steroid. The U.S. Centers for Disease Control and Prevention confirmed that 169 people in 11 states have contracted fungal meningitis after spinal injections of the steroid. One person has contracted a joint infection after receiving an injection for ankle pain.

Seventy-six clinics in 23 states that received methylprednisolone acetate from the recalled lots have been instructed to notify all affected patients. The "potentially contaminated injections were given starting May 21, 2012," according to the CDC.

Puro claimed she received a spinal steroid injection Sept. 17 and developed headaches and nausea -- subtle symptoms of fungal meningitis. The following week, she received a call from the clinic that administered the shot, saying she might be at risk for fungal meningitis. The results of her spinal tap, a diagnostic test for meningitis, are pending, according to the lawsuit.

Puro filed the class action on behalf of all patients in Minnesota who received the recalled steroid. So far, the state has three known cases of infection and no reported deaths. Infections have also been reported in Tennessee, Michigan, Virginia, Indiana, Maryland, Florida, North Carolina, Ohio, New Jersey and, most recently, Idaho.

Meningitis affects the membranous lining of the brain and spinal cord. Early symptoms of fungal meningitis, such as headache, fever, dizziness, nausea, sensitivity to light, stiff neck, weakness or numbness, slurred speech and pain, redness or swelling at the injection site can take more than a month to appear.

The longest duration from the time of injection to the onset of symptoms in the current outbreak is 42 days, according to the CDC's Dr. Benjamin Park.

"But we want to emphasize that we don't know what the longest will be," he said, adding that patients who received injections of the recalled drug should stay attuned to the subtle symptoms "for months."

Fungal meningitis is diagnosed through a spinal tap, which draws cerebrospinal fluid from the spine that can be inspected for signs of the disease. Once detected, it can be treated with high doses of intravenous antifungal medications.

People affected by the current outbreak are being treated with two different types of antifungal medications until the type of fungus causing the infection -- aspergillus or exserohilum -- can be identified.

The CDC has confirmed one case of aspergillus meningitis and 10 cases of exserohilum meningitis. It's unclear how the fungi landed in the steroid vials.

Unlike bacterial meningitis, fungal meningitis is not transmitted from person to person and only people who received the steroid injections are thought to be at risk.

Puro claims the New England Compounding Center "was negligent because it failed to use reasonable care when it designed, tested, manufactured, marketed and sold doses of methylprednisolone acetate," and that she and others who received the recalled drug have "suffered serious bodily harm, other personal injuries and emotional distress, and have incurred medical and other expenses." She is seeking compensation for damages, attorney fees and other costs.

Copyright 2012 ABC News Radio

Thursday
Oct112012

Fungal Meningitis Outbreak: 170 Cases, 14 Deaths

Hemera/Thinkstock(ATLANTA) -- The U.S. Centers for Disease Control and Prevention reported two more deaths linked to the outbreak of fungal meningitis from steroid shots for back pain, bringing the total number of people who have died to 14.

The CDC also reported that 170 cases of the rare form of fungal meningitis have now been reported in 11 states.

The outbreak of aspergillus meningitis has been linked to an injectable steroid, called methylprednisolone acetate, made by the New England Compounding Center in Framingham, Mass. A sealed vial of the drug, obtained by the U.S. Food and Drug Administration, contained levels of fungus that were visible to the naked eye.

The New England Compounding Center has recalled all of its products and shut down operations, but health officials estimate that 13,000 people may have been exposed to the suspect steroid since May.

Forty-nine of the fungal meningitis cases -- six of them lethal -- have been reported in Tennessee. Cases have also been reported in Florida, Indiana, Maryland, Michigan, Minnesota, New Jersey, North Carolina, Ohio, Virginia and, most recently, Idaho.

[For a map of cases by state, click here.]

Seventy-six clinics in 23 states that received methylprednisolone acetate from the recalled lots have been instructed to notify all affected patients. The "potentially contaminated injections were given starting May 21, 2012," according to the U.S. Centers for Disease Control and Prevention.

For a full list of clinics receiving the recalled lots of spinal steroid injections, click here.

"If patients are concerned, they should contact their physician to find out if they received a medicine from one of these lots," said CDC's Dr. Benjamin Park, adding that most of the cases occurred in older adults who were healthy aside from back pain.

Meningitis affects the membranous lining of the brain and spinal cord. Early symptoms of fungal meningitis, such as headache, fever, dizziness, nausea, sensitivity to light, stiff neck, weakness or numbness, slurred speech and pain, redness or swelling at the injection site can take nearly a month to appear. Left untreated, the inflammatory disease can cause permanent neurological damage and death.

"Fungal meningitis in general is rare. But aspergillus meningitis -- the kind we're talking about here -- is super rare and very serious," said Dr. William Schaffner, president of the National Foundation for Infectious Diseases and chairman of preventive medicine at Vanderbilt University Medical Center in Nashville. "There's no such thing as mild aspergillus meningitis."

Fungal meningitis is diagnosed through a lumbar puncture, which draws cerebrospinal fluid from the spine that can be inspected for signs of the disease. Once detected, it can be treated with high doses of intravenous antifungal medications.

"Treatment could be prolonged, possibly on the order of months," said Park, adding that the IV treatment would require a hospital stay.

Unlike bacterial meningitis, fungal meningitis is not transmitted from person to person and only people who received the steroid injections are thought to be at risk.

Copyright 2012 ABC News Radio







ABC News Radio