meningitus lawyer

FDA Alert, New England Pharmacy Fungal Medication

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As menigitus spreads the FDA issues as alert. Medical professionals are put on guard regarding tained steroid medication for New England Compouding Center :

New England Compounding Center (NECC) Potentially Contaminated Medication: Fungal Meningitis Outbreak
October 6, 2012 Med Watch Alert

[UPDATED 10/06/2012] On October 4, 2012, the CDC and FDA recommended that all health care professionals cease use and remove from their pharmaceutical inventory any product produced by the New England Compounding Center (NECC), located at 697 Waverly Street in Framingham, MA. The Massachusetts Department of Public Health (DPH) is collaborating with the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) on a multi-state investigation of Aspergillus meningitis among patients who received an epidural steroid injection.

As of October 4, 2012, 35 cases have been reported to CDC, including 5 deaths. The three principally implicated lots have not been distributed in Massachusetts. According to CDC, fungal meningitis, which is not transmitted from persons to person, from a potentially contaminated drug product is suspected to be the cause of the outbreak. At this time, no cases have been reported in Massachusetts. Specific information on these recalled products is located at the links provided below. Additionally, the CDC is updating information for clinicians daily at 2 pm at the following webpage: http://www.cdc.gov/hai/outbreaks/meningitis.html.

With questions regarding case definitions of Aspergillus meningitis, please contact the DPH Epidemiology Hotline: 617-983-6800.

[Posted 10/05/2012]

ISSUE: FDA has observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of methylprednisolone acetate collected from New England Compounding Center (NECC). FDA is in the process of conducting additional microbial testing to confirm the exact species of the fungus.

Investigation into the exact source of the outbreak is still ongoing, but the outbreak is associated with a potentially contaminated medication. That product is preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid produced and distributed by New England Compounding Center (NECC) in Framingham, Massachusetts. CDC’s interim data show that all infected patients received injection with this product.

BACKGROUND: FDA was been working closely with CDC, several state health departments, and the Massachusetts Board of Pharmacy to investigate the scope and cause of the outbreak of fungal meningitis. FDA inspectors in the New England District Office, in cooperation with the Massachusetts Board of Registration in Pharmacy have been conducting an inspection of the New England Compounding Center. The firm voluntarily ceased all operations and surrendered its license to the Massachusetts Board of Registration in Pharmacy on October 3, 2012.

RECOMMENDATION: Out of an abundance of caution, FDA is taking the additional step of recommending that health care professionals and consumers not use any product that was produced by NECC at this time. In addition, FDA requests that health care professionals retain and secure all remaining products purchased from NECC until FDA provides further instructions regarding the disposition of these products.

Although the investigation into the source of the outbreak is still ongoing, if you have purchased a product from NECC, FDA is advising not to use it at this time. This includes all products compounded and distributed at NECC; not just the ones that have been recalled. Please see the CDC website for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA s MedWatch Safety Information and Adverse Event Reporting Program:

Meningitus Outbreak Due To Steroid Medication, Meningitus Lawyers Ready as 26 States Effected

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A menigitus outbreak is now expanding to 26 states. The outbreak is linked to a contaminated shipment of steroid medication from a Massachusetts compounding pharmacy. Product liability lawyers are looking at injuries and potential deaths increasing. According to the product liabilities lawyers of Free Legal Shield there may be a huge number of pharmaceutical liability lawsuits filed against the manufacturer of thi s product. A manufacturer can be held liable for injury and death due to contamination of it s products. The hardest hit has been a clinic in Nashville Tennessee.


By

Michelle Castillo /
CBS News/ October 4, 2012, 3:22 PM
Meningitis outbreak may affect more than 23 states

The Centers for Disease and Control and Prevention (CDC) and Food and Drug Administration (FDA) announced today they are advising medical professionals not to use any products manufactured by the New England Compounding Center in Framingham, Mass., due to an outbreak of fungal meningitis tied to some medications made by the company.

Three lots of the company s preservative-free methylprednisolone acetate that go back to July 2012 have been recalled and are believed to be the cause of the recent outbreak. Thirty-five cases of fungal meningtitis in six states have been identified, with five deaths. The majority of the cases, 25 in total, have been discovered in Tennessee.

"Given the severity of illness, we believe these precautionary measures are warranted to protect public health," Ilisa Bernstein, director of the FDA office of compliance, said to reporters during a conference call today.

Meningitis outbreak sickens 35 in 6 states, kills 5
Tenn. meningitis outbreak tied to steroid shots

Dr. Benjamin Park, medical epidemiologist with the Centers for Disease Control and Prevention, told reporters that 23 states may have received shipments of the tainted product. These states include: California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas and West Virginia. A total of 75 facilities may have received product from one of these three recalled lots.


Deadly meningitis outbreak in U.S.

However, because the New England Compounding Center is licensed in all 50 states, there is a possibility contaminated products may be in other areas, Bernstein said.

"We don t know the scope of this," she admitted.

The initial three-lot recall by the New England Compounding Center involved 17,676 vials, the CBS News Investigative Team reported. There were two complaints filed against the company one in 2002, one in 2003 that were investigated and as a result the company entered into an agreement in 2006 with the Massachusetts Department of Health to correct any deficiencies. That same year, the FDA warned the company against compounding topical anesthetic creams for general distribution.

In March 2012, a complaint unrelated to the meningitis case was filed against the company regarding the potency of its eye medication. That complaint is still open and pending, according to the investigative team.

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Meningitis outbreak linked to Mass. pharmacy

Fungal meningitis is a non-contagious form of the disease. It is often caused by fungus normally found in leaf mold. Authorities said some people were experiencing mild stroke-like symptoms, including slurred speech, and difficulty walking and urinating. Other fungal meningitis symptoms include worsening and severe headache, nausea, dizziness and fever.

It can be treated with high-dose antifungal medications, usually given intravenously in a hospital. The earlier the disease is diagnosed and treated, the better the chances of survival are.

"We think that early antifungal treatment can improve the outcome of these patients," Park said.

Park said that the CDC was notified of a patient with an onset of meningitis 19 days after receiving an epidural steroid injection on Sept. 21 in Tennessee. Although all initial cultures were negative, fungus was isolated from the patient s cerebral spinal fluid. On Sep. 28, the CDC was notified of cases outside of Tennessee.

In total, one case in North Carolina, two cases in Florida, four cases in Virginia, two cases in Maryland and one case in Indiana have been discovered in addition to the 25 cases in Tennessee. Three people have died in Tennessee, as well as one person from Virginia and one person from Maryland.

The victims tend to be elderly because of the nature of patients who receive spinal epidural injections because of lower back pain. Overall, many of the patients were somewhat healthy until infection.

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Woman may have been exposed to meningitis

On Oct. 1, the New England Compounding Center voluntarily shut down their manufacturing center. During a FDA investigation of the plant, the investigators discovered contaminants in an unopened vial.

"Materials from an unopened vials was looked at under the microscope at an FDA lab and what was looked at under the microscope looked like a fungal matter," an FDA spokesperson confirmed.

The FDA added that they are working with the firm to get more information about their products. The