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 The leading web portal for pharmacy resources, news, education and careers September 1, 2014
Pharmacy Choice - Pharmaceutical News - FDA lists venues that got drug-maker's products [Milwaukee Journal Sentinel] - September 1, 2014

Pharmacy News Article

 10/25/12 - FDA lists venues that got drug-maker's products [Milwaukee Journal Sentinel]

Oct. 25The U.S. Food and Drug Administration has released a list of about 3,000 hospitals, medical facilities and pain centers including 81 in Wisconsin that were shipped products from the drug manufacturer at the center of a deadly nationwide meningitis outbreak.

The FDA is warning medical professionals not to use any products made by the drug manufacturer.

The meningitis outbreak, which has killed 24 people in 17 states and sickened hundreds of others, has been traced to an injectable steroid called methylprednisolone that is used to treat neck and back pain. None of the facilities in Wisconsin has received those contaminated steroids, according to the Centers for Disease Control and Prevention, but the 81 listed have received other products made by the New England Compounding Center.

All products produced by the company have been recalled. The FDA said products shipped from the New England Compounding Center on or after May 21, 2012, are believed to be of greatest risk for contamination.

Health care providers have been urged to notify patients who were given an injectable product made by the New England Compounding Center.

This month University of Wisconsin Hospital and Clinics sent a letter to patients who had received any drug made by the company.

In the letter, the hospital told patients that "there is no known contamination of the . . . medication you received. Despite this, we felt it our duty to share information about any risk, however small it may be, and for you to speak with your physician about any questions you may have."

Froedtert and the Medical College of Wisconsin will send letters to about 4,500 people who might have received products made by the New England Compounding Center.

"It is highly unlikely these patients received contaminated medications and we believe the risk of infection to these patients is extremely low," Froedtert public relations director Kathleen Sieja said in a statement.

The facilities that have received products from the New England Compounding Center range from large health systems to doctors' offices to pain, surgery and podiatry centers.

Michael Carome, deputy director of consumer advocacy group Public Citizen's health research group, said the New England Compounding Center was not following safe and sterile procedures in its manufacturing plant.

"It is certainly conceivable that other products made within the facility were contaminated," he said.

The FDA, CDC and state and local health departments are continuing to investigate the outbreak of fungal meningitis, which is not contagious.

On its website the FDA said it "cannot vouch for the completeness or accuracy" of the lists because information was provided from the drug manufacturer.

Data on Demand

To see which hospitals received shipments from the New England Compounding Center, go to www.jsonline.com/dataondemand

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(c)2012 the Milwaukee Journal Sentinel

Visit the Milwaukee Journal Sentinel at www.jsonline.com

Distributed by MCT Information Services




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