Latest Meningitis Outbreak Toll: 20 Deaths and 257 Infections, CDC Says

By Steven Reinberg and Margaret Steele
HealthDay Reporters

THURSDAY, Oct. 18 (HealthDay News) -- Another person has died and 10 more have been sickened in the nationwide meningitis outbreak believed to be tied to contaminated steroid injections, bringing the totals to 20 deaths and 257 infections, U.S. health officials reported Thursday.

It's suspected that the steroid, contaminated with a fungus, was manufactured by the New England Compounding Center of Framingham, Mass. Last month the company voluntarily recalled three lots of the steroid, methylprednisolone acetate, which is injected into patients for back and joint pain. The company has since shut down operations and stopped distributing its products, health officials said.

On Thursday, federal health officials said they'd confirmed the presence of a fungus known as Exserohilum rostratum in unopened vials of the steroid from one of the three lots. The laboratory confirmation further links the steroid from these lots and the subsequent infections to the Massachusetts specialty pharmacy, said officials from the U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration.

Tests on the other two lots and other injectable products from the company are continuing, officials said.

The CDC and state health departments estimate that roughly 14,000 patients may have gotten steroid injections from the three lots, and nearly 97 percent of them have been contacted for medical follow-up.

Meningitis is potentially fatal inflammation of the lining surrounding the brain and spinal cord.

All of the 254 fungal meningitis patients were thought to be injected with methylprednisolone acetate, according to the CDC.

There have been three cases of what the CDC calls "peripheral joint infection," meaning an infection in a knee, hip, shoulder or elbow. These joint infections aren't considered as dangerous as injections near the spine for back pain that have been linked to the potentially fatal meningitis infections.

The 14,000 people who may have gotten injections of the steroid include not only patients who got shots for back pain and are most at risk for meningitis, but also others who received shots for pain in their knees and shoulders.

All of the infected patients are thought to have received the medication from the Massachusetts pharmacy, according to the CDC.

The FDA said it was advising all health-care professionals to follow up with any patients who were given any injectable drug from or produced by the New England Compounding Center. These drugs include medications used in eye surgery, and a heart solution purchased from or produced by the company after May 21.

The New England Compounding Center is what's known as a compounding pharmacy. These pharmacies combine, mix or alter ingredients to create specific drugs to meet the specific needs of individual patients, according to the FDA. Such customized drugs are frequently required to fill special needs, such as a smaller dose, or the removal of an ingredient that might trigger an allergy in a patient.

The CDC on Thursday had the following state-by-state breakdown of cases: Florida: 13 cases, including 3 deaths; Idaho, 1 case; Illinois, 1 case; Indiana: 34 cases, including 2 deaths; Maryland: 16 cases, including 1 death; Michigan: 49 cases, including 4 deaths; Minnesota: 7 cases; New Hampshire: 8 cases; New Jersey: 13 cases; New York: 1 case; North Carolina: 2 cases; Ohio: 10 cases; Pennsylvania: 1 case; Tennessee: 63 cases, including 8 deaths; Texas: 1 case; Virginia: 37 cases, including 2 deaths.

Health officials said they expect to see more cases of the rare type of meningitis, which is not contagious, because symptoms can take a month or more to appear.

Infected patients have developed a range of symptoms approximately one to four weeks following their injection. People who have had a steroid injection since July, and have any of the following symptoms, should talk to their doctor as soon as possible: worsening headache, fever, sensitivity to light, stiff neck, new weakness or numbness in any part of your body, slurred speech, the CDC said.

Infected patients must receive intravenous drugs in a hospital.

Compounding pharmacies like the New England Compounding Center traditionally started out as community-based neighborhood druggists. But over time, the practices of some compounding pharmacies have expanded, sometimes beyond their intended limits, experts explained.

According to the Associated Press, this isn't the first time the New England Compounding Center has encountered problems with contaminated injections. In 2007, the company settled a lawsuit that claimed that an 83-year-old man died in 2004 after contracting fatal bacterial meningitis from a shot produced by the compounding center. The pharmacy reached a settlement with the man's widow before the case went to trial, the AP said.

Compounding pharmacies aren't subject to the same FDA oversight as regular drug manufacturers are, and some members of Congress now say the meningitis outbreak highlights the need for more regulatory control.

The CDC released a list of the approximately 75 health-care facilities that received contaminated product.

Copyright © 2012 HealthDay. All rights reserved. SOURCES: Oct. 18, 2012, news release, U.S. Centers for Disease Control and Prevention, and U.S. Food and Drug Administration; Oct. 18, 2012, updated statistics, U.S. Centers for Disease Control and Prevention; Associated Press

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Official: Pharmacy Tied to Meningitis Outbreak May Have Broken State Law

By Steven Reinberg
HealthDay Reporter

THURSDAY, Oct. 11 (HealthDay News) -- The company at the center of the ongoing meningitis outbreak appears to have violated Massachusetts law by producing and distributing large quantities of a contaminated steroid compound, a state health official said Thursday.

According to Massachusetts law, so-called compounding pharmacies like the company in question -- the New England Compounding Center -- are only licensed to produce medications to fill single prescriptions for individual patients, said Dr. Madeleine Biondolillo, director of the Department of Public Health's Bureau of Health Care Safety and Quality.

"Through the investigation, it looks like they have violated that aspect of the state licensing regulations despite their assertion that they were operating under the regulation," Biondolillo said during an afternoon news conference.

"Yesterday, the Massachusetts board of pharmacies issued an alert to all compounding pharmacies to reinforce with them the rules they must abide by in Massachusetts," she added. "Compounding can only be conducted upon the receipt of a patient-specific prescription."

Biondolillo said more oversight of compounding pharmacies is needed, both on the state and federal levels.

Compounding pharmacies -- which historically started out as community-based neighborhood druggists -- combine, mix or alter ingredients to create specific drugs to meet the specific needs of individual patients, according to the U.S. Food and Drug Administration. Such customized drugs are frequently required to fill special needs, such as a smaller dose, or the removal of an ingredient that might trigger an allergy in a patient.

But over time, the practices of some compounding pharmacies have expanded, often beyond their intended limits, experts explained.

As of Thursday, 170 people had confirmed meningitis infections due to the contaminated steroids and 14 had died. These illnesses and deaths occurred in 11 of the 23 states where the steroids were shipped, Dr. J. Todd Weber, chief of U.S. Centers for Disease Control and Prevention's Prevention and Response Branch, Division of Healthcare Quality Promotion, said during the news conference.

Meningitis is a potentially fatal inflammation of the lining of the brain and spinal cord.

The CDC said infections and deaths had been reported in the following states: Florida: 7 cases, including 2 deaths; Idaho, 1 case; Indiana: 21 cases, including 1 death; Maryland: 13 cases, including 1 death; Michigan: 39 cases, including 3 deaths; Minnesota: 3 cases; New Jersey: 2 cases; North Carolina: 2 cases; Ohio: 3 cases; Tennessee: 49 cases, including 6 deaths; Virginia: 30 cases, including 1 death.

Fungus linked to the outbreak has been found in 50 vials of the drug taken from the manufacturer and from pain clinics around the country, Deborah Autor, the FDA's deputy commissioner for global regulatory operations and policy, said at the news conference.

The company is believed to have shipped more than 17,000 vials of the steroid drug, called methylprednisolone acetate, to 23 states.

"The first cases from Tennessee had an infection from a fungus known as aspergillus, the CDC's Weber said. "Since that time, confirmed cases have all had infection caused by a different fungus known as exserohilum."

Exserohilumm infection has been confirmed in 10 people with meningitis, and aspergillus has been confirmed in only one person -- the first case, Weber said. Both types of infection are extremely rare, he said, adding, "This is new territory for public health and the clinical community."

As many as 14,000 people may have been exposed to the contaminated steroids, Weber said. The CDC has so far been able to contact some 11,000 of those patients, he said.

The most serious infections have been reported by those receiving injections in the lower back, near the spine, to relieve chronic back pain. Others have gotten shots for pain in joints like the knee, ankle or shoulder, Weber said.

Weber also reported the first case of infection in someone who received an injection in a joint. "This person received an injection from one of the three recalled lots [recalled by the New England Compounding Center]," he said. Whether the infection is meningitis hasn't been confirmed yet, he said.

The New England Compounding Center was shut down on Oct. 3, Autor said. Massachusetts officials have also pulled the company's license to operate.

Autor said the FDA also inspected another Massachusetts-based compounding pharmacy, Ameridose, which is affiliated with the New England Compounding Center. That inspection failed to turn up any irregularities and no recall of its products has occurred so far, she said.

Copyright © 2012 HealthDay. All rights reserved. SOURCES: Oct 11, 2012, press conference with J. Todd Weber, M.D, incident manager, Multistate Meningitis Outbreak, and chief, Prevention and Response Branch, Division of Healthcare Quality Promotion, U.S. Centers for Disease Control and Prevention; Madeleine Biondolillo, M.D., director, Department of Public Health, Bureau of Health Care Safety and Quality, Massachusetts Department of Public Health; Deborah Autor, J.D., deputy commissioner, Global Regulatory Operations and Policy, U.S. Food and Drug Administration

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Meningitis Crisis Expands; More Infections, Deaths

By Brenda Goodman, MA
WebMD Health News

Reviewed by Louise Chang, MD

Oct. 11, 2012 -- The crisis surrounding the multistate outbreak of fungal meningitis linked to tainted steroid shots deepened Thursday, as federal officials reported that more people had received the shots than previously believed. Doctors also reported the first case of a joint infection outside the spine.

The CDC says close to 14,000 people may have gotten the shots, not 13,000 as was first estimated.

Fourteen people have died since the outbreak was first reported last month.

In all, 169 cases of the rare brain infection have been reported in 11 states. Tennessee, Michigan, Virginia, Indiana, and Maryland have been the hardest hit.

"These 14,000 patients received the medication as a steroid injection either in the spinal area or into a joint space, such as a knee, shoulder, or ankle," said J. Todd Weber, MD, chief of the Prevention and Response Branch, Division of Healthcare Quality Promotion at the CDC, in a press briefing.

Health officials have contacted about 90% of the affected patients to warn them about possible health risks related to the shots.

"We know we are not out of the woods yet," Weber said, noting that it can take weeks to months to develop symptoms of a fungal infection. Those include headache, fever, back pain, nausea, and redness or swelling at the injection site.

"Patients and their doctors will need to be vigilant for at least several months following injection," said Weber, who is leading the response to the outbreak for the CDC. He urged patients who were feeling unwell to seek immediate medical attention.

He also warned patients and doctors that it is difficult to test for the two fungi that have been causing the meningitis cases. The CDC confirmed the presence of the fungus exserohilum in 10 of the people with meningitis and the fungus aspergillus in one person with meningitis.

"Patients who received an injection with one of the three recalled lots of steroids may be diagnosed with meningitis, but their fungal testing may be negative. In these cases, patients should still be treated for meningitis," Weber said.

So far, 50 vials of methylprednisolone acetate from the New England Compounding Center, in Framingham, Mass., have tested positive for two species of fungus linked to the outbreak.

In addition, federal officials said on Thursday that one patient had an infected ankle after receiving one of the shots. Doctors are waiting on a lab test to determine whether that infection was caused by a fungus, as the meningitis cases were.

In rare cases, fungal infections in the joints can cause septic arthritis, says Luis Ostrosky-Zeichner, MD.

"Infections in the joint are generally very severe because they destroy a lot of the lining of the joint, and they're very disabling," says Ostrosky-Zeichner, director of the laboratory of mycology research at the University of Texas Health Science Center in Houston.

Ostrosky-Zeichner says fungal arthritis may require surgery and months of treatment with intravenous antifungal drugs, which are known to be toxic to the kidneys and other organs.

"We know how upsetting these recent events have been, and we send our deepest sympathies to all who are impacted by this tragic situation," said Deborah M. Autor, JD, deputy commissioner for Global Regulatory Operations and Policy at the FDA.

The FDA's role in regulating compounding pharmacies was limited in 2002. The agency is largely empowered to act only after a problem has already been identified.

"What this points out is that the practice of pharmacy has changed quite a bit. The world has changed a lot since the days of mortar and pestle. This is the time for pharmacists, for lawmakers, for regulators, for doctors, to sit down and grapple with this new model of pharmacy compounding and come up with a regulatory scheme that controls the risk," Autor said.

SOURCES: Joint press briefing, CDC, FDA, and the Massachusetts Department of Health. Luis Ostrosky-Zeichner, MD, director of the laboratory of mycology research, The University of Texas Health Science Center in Houston, Texas.Deborah M. Autor, JD, Deputy Commissioner for Global Regulatory Operations and Policy, FDA. J. Todd Weber, MD, Chief of Prevention and Response Branch, Division of Healthcare Quality Promotion, CDC.

©2012 WebMD, LLC. All Rights Reserved.

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