FDA lists venues that got drugmaker's products

By MILWAUKEE JOURNAL SENTINEL AND GAZETTE STAFF   Friday, Oct. 26, 2012
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Two hospitals in Rock County that received products from the drug company at the center of the deadly nationwide meningitis outbreak pulled their products when the outbreak started, hospital officials said.

The U.S. Food and Drug Administration released a list of about 3,000 hospitals, medical facilities and pain centers—including 81 in Wisconsin—that were shipped products from the New England Compounding Center.

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.

Officials at St. Mary's Janesville Hospital and Beloit Memorial Hospital said they have followed the FDA's warning not to use any products made by the drug company. Neither hospital used the drug linked to the fungal meningitis cases, but the hospitals did receive other products from the company.

"It is very important to note that none of these products has been linked to the meningitis cases or to any other adverse events in patients—anywhere in the nation," Joan Neeno, director marketing and public relations for St. Mary's, said in a statement. "All drugs from that company were immediately pulled from our inventory when we learned of the meningitis cases. To date, we have received no indication that any of our patients has had an adverse reaction as a result of using drugs from NECC. We are absolutely committed to the highest patient safety."

Dr. Leland From, vice president of medical affairs at Beloit Health System, said the products sent to Beloit were pulled weeks ago and no problems have been reported. The hospital was in the process of sending a letter to patients who received the medications.

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 by the manufacturer.

St. Mary's encouraged any patient who has questions or concerns to call the hospital at 608-373-8033 or to contact their physician.

reader COMMENTS
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(4)
Zeussmom
Oct 27, 2012 at 6:37 a.m.
Suggest removal

I had recently had a steroid injection in my spine at Mercy and even though they may not use that manufacturer it would have been nice to hear something from them that they don't use the product in question.

janesvillean
Oct 27, 2012 at 5:06 a.m.
Suggest removal

Mercy Health System is not on the FDA list of facilities that received products from the vendor. Beloit Memorial and St. Mary's are on the list.
http://www.fda.gov/Drugs/DrugSafety/Fung...

starbuck
Oct 26, 2012 at 8:43 p.m.
Suggest removal

Good question. I'd like to know as well.

ms_sassy_wi
Oct 26, 2012 at 8:33 p.m.
Suggest removal

not an accusation by any means, but Mercy Health System is very obviously missing from this article...they do not use any medications from NECC? Ever? Were they contacted by a reporter? Are they not cooperating? Is there more to this or is it just a non-issue?

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