Fungal Meningitis Deaths Rise, Investigators Raid NECC

The Centers for Disease Control and Prevention logged two additional deaths from the multistate meningitis outbreak Wednesday, bringing the total to 19. The number of cases identified also jumped from the 233 recorded as of Tuesday to 247. This meningitis resulted from contaminated medication and is not communicable, the CDC noted.

This is the first time in history the United States has experienced a fungal meningitis outbreak caused by Exserohilum and Aspergillus fungi, the CDC told the Associated Press.

Current Investigations

Multiple investigations of New England Compounding Center of Framingham, Mass., the company producing the tainted medicines, are underway. Investigators are also looking at Ameridose, Inc., another pharmacy owned the family that owns NECC.

Food and Drug Administration agents raided NECC's Framingham operation Tuesday, Reuters reported.

U.S. Attorney Carmen M. Ortiz confirmed for the Wall Street Journal her office has opened an investigation into NECC's activities.

The Massachusetts Dept. of Public Health has been investigating the company.

The U.S. House of Representatives Energy and Commerce Committee expanded its investigation into the company's activities and is now subpoenaing FDA documents. The Committee is looking at whether FDA checked the company's compliance with its prior orders or took the company at its word, Reuters noted.

Before the Outbreak

There were hints of looming trouble before the meningitis outbreak. The Boston Globe cited several employees who expressed concern about pressure to work fast and disregard of safety in the push to profit. At least one of the Ameridose employees, Ronnie Leger, made official complaints last year with the FDA and Occupational Safety and Health Administration and says he got fired for doing so, according to the Globe.

An FDA inspection in 2008 detected deficiencies at Ameridose, including shipping drugs prior to ensuring their sterility.

NECC entered a consent order with the state in 2006, the Globe said, based on several concerns including potential contamination of a cancer drug.

In 2002, a patient died after receiving a tainted injection made by NECC. The Globe noted that death resulted in a lawsuit that was settled.

Advice for Consumers

Because this fungal meningitis outbreak is the first of its kind, the CDC is developing is diagnostic and treatment recommendations as circumstances evolve. It recommends consumers concerned they may have received tainted medicine consult their doctors to determine what medicine they received. Patients who know they've been treated with potentially contaminated medication who suffer symptoms should seek medical treatment, the CDC says.

Those who received tainted medication may contract fungal meningitis or develop fungal infections in their joints if the injection was administered in a joint space.

A four-week timeframe between injection and symptom onset is typical, the CDC said, but both shorter and longer timeframes have been reported.

Symptoms to look out for fungal meningitis include new or worsening headache; fever; sensitivity to light; stiff neck; new weakness or numbness anywhere in body; slurred speech; or increased pain, redness or swelling at the injection site. Joint infection symptoms include fever; increased pain; and redness, warmth, or swelling in the affected joint or at the injection site.

All New England Compounding Center Products Recalled

As a result of the ongoing investigations, all products manufactured by New England Compounding Center of Framingham, Mass., were recalled. A complete list of recalled products is available on the FDA website.

New England Compounding Center and Ameridose have temporarily ceased operations.

Carol Bengle Gilbert writes about consumer issues for the Yahoo! Contributor Network.

Source: http://news.yahoo.com/fungal-meningitis-deaths-rise-investigators-raid-necc-215400806--finance.html

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