Thursday, December 12, 2013
The Associated Press
Long before the current rash of fungal meningitis, the compounding pharmacy suspected in the outbreak settled a lawsuit alleging it produced a tainted shot that caused a man's death in 2004.
Ameridose Sterile Admixing Services in Westborough, Mass., a sister company to the New England Compounding Center, has agreed to be shut down for state and federal inspection.
The Associated Press
CDC SAYS IT'S TRACKED DOWN
MOST OF THE 14,000 AT RISK
WASHINGTON - Federal health officials said they've tracked down more than 90 percent of the roughly 14,000 people who may have received contaminated steroid shots, urging anyone with early symptoms of potentially deadly meningitis to seek help fast.
Of the 170 people sickened in the outbreak, all but one have a rare fungal meningitis, and 14 have died, the Centers for Disease Control and Prevention said Thursday. One person identified by Michigan health officials received the steroid shot in the ankle and has an infection there. While the biggest concern is for people given the shots for back pain, the CDC said people who received the injections in joints should also be alert to signs of localized infection, including redness, pain, swelling and fever.
More than 50 vials of the steroid produced by a specialty pharmacy in Massachusetts, the New England Compounding Center, have been found contaminated with some sort of fungus, said Deborah Autor of the Food and Drug Administration. The investigation is continuing into how the contamination could have occurred.
But Dr. Madeleine Biondolillo of the Massachusetts Department of Public Health said Thursday that it appears the company violated state law governing how compounding pharmacies are supposed to work. They are not supposed to do large-scale production like a drug manufacturer, but to produce medication for patient-specific prescriptions, she said .
– The Associated Press
Earlier this summer, a separate pharmaceutical firm with common owners was accused of failing to separate sterile and non-sterile supplies. That pharmaceutical company was shut down Wednesday for inspections, the latest example of fallout from the growing outbreak.
Officials have identified Framingham, Mass.-based New England Compounding Center as the source of steroid shots suspected in the outbreak of rare fungal meningitis that has killed at least 12 people and made more than 130 others sick in 10 states.
Allegations that a shot tainted with bacteria caused a man to contract a different form of meningitis were at the heart of a lawsuit filed against the company over the 2004 death. An 83-year-old man died about a year and a half after receiving a shot produced by the company.
The case settle prior to trial, said Mark S. Nunn, a lawyer for the widow of the New York man. He declined to elaborate.
Another drug company that has some of the same owners, Ameridose LLC, agreed to temporarily stop its compounding and manufacturing operations as a precaution while regulators inspect its facilities, but the measure is being done as a precaution, not because of evidence of contamination, officials said Wednesday. Ameridose, based in Westborough, Mass., was accused by a business customer this year of failing to separate sterile and non-sterile products in its warehouse.
Andrew Paven, a spokesman for both companies, said: "Ameridose is a separate entity from New England Compounding Center, with distinct operational management."
"We have separate production facilities, separate processes and operate at separate locations in different cities. Although there is common ownership, the two companies operate under separate registrations and different licensure," the statement from Paven said.
On Wednesday, Massachusetts Gov. Deval Patrick said New England Compounding Center may have misled regulators and done work beyond the scope of its state license.