BBC News, 17
October 2012
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Concerns were raised about sterility and cleanliness at the pharmaceutical firm |
Investigators
in the United States have raided the premises of a Massachusetts pharmaceutical
company linked to a meningitis outbreak.
The Food
and Drug Administration (FDA) raised concerns about sterility and cleanliness
at the New England Compounding Center (NECC).
So far 16
people have died from a rare fungal form of meningitis, apparently after using
contaminated drugs.
More than
200 people in 15 US states have been affected.
Steroids
and heart drugs produced by the Boston-based NECC are under investigation and
the FDA has warned doctors not to prescribe any of the company's products.
Meningitis
is an inflammation of the membranes covering the brain and spinal cord.
Symptoms include severe headache, nausea and fever as well as slurred speech
and difficulty walking.
Fungal
meningitis is not contagious, according to US health officials.
Compounding
concerns
Criminal
investigators from the FDA searched the NECC premises on Tuesday as part of a
broad state and federal investigation into the deadly outbreak.
Paul Cirel,
a lawyer for the pharmaceutical company, told Associated Press that it was
"difficult to understand the purpose" of the FDA search. He said the
company has made clear it would provide, and has provided, anything requested
by investigators.
They have
been several calls by US congressmen for a full-scale criminal investigation
into the NECC's practices.
The
outbreak has raised questions about the practice of drug compounding, where
pharmacies prepare specialised doses of medication. Compounding is not
regulated by the FDA, which generally oversees drug makers.
NECC has
suspended operations and recalled the steroid injection initially linked with
the outbreak, methylprednisolone.
The Food
and Drug Administration says it is looking into reports of a patient with
possible meningitis who received an injection of triamcinolone, a different
steroid, from NECC.
Two
transplant patients also developed a fungal infection after receiving an
unnamed heart drug made by the firm.
The FDA has
not confirmed that these three infections were caused by NECC products, and has
said that it is very possible that the heart patients were infected by another
source.
On Monday,
the drug regulator expanded its recommendation for doctors to warn anyone who
received any injection made by the company, including drugs used in eye
surgery.
Last week,
health officials said 12,000 of the roughly 14,000 people in 23 states who
received the steroid shots had been contacted.
The CDC has
published a list of clinics that received shipments of the drug, which was
recalled on 26 September.
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