FDA: Pharmacy's other drugs may be causing illness
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Map shows states affected by the meningitis outbreak and those receiving suspected tainted medications. |
NEW YORK (AP)
-- Two more drugs from a specialty pharmacy linked to a meningitis
outbreak are now being investigated, U.S. health officials said, as they
urged doctors to contact patients who got any kind of injection from
the company.
The New England Compounding
Center of Framingham, Mass., has been under scrutiny since last month,
when a rare fungal form of meningitis was linked to its steroid shots
used mostly for back pain.
Monday's step by
the Food and Drug Administration followed reports of infections in three
people who got different drugs made by the company. One is a possible
meningitis illness in a patient who got a spine injection of another
type of steroid. The agency also learned of two heart transplant
patients who got fungal infections after being given a third company
product during surgery.
The illnesses are
under investigation, and it's very possible the heart patients were
infected by another source, FDA officials cautioned. They did not say
whether the meningitis case involved a fungal infection or where the
three patients lived.
As of Monday, the
current outbreak has sickened 214 people, including 15 who have died, in
15 states. For weeks, officials have been urging doctors to contact
patients who got shots of the company's steroid methylprednisolone
acetate, advise them about the risks of fungal infection, and urge them
to take any meningitis symptoms seriously.
The steroid was recalled last month, and the company later shut down operations and recalled all the medicines it makes.
The
FDA on Monday expanded its advice to doctors to contact all patients
who got any injection made by the company, including steroids and drugs
used in eye surgery as well as heart operations. The agency said it took
the step "out of an abundance of caution" as it investigates the new
reports involving the heart surgery drug and the second steroid, called
triamcinolone acetonide.
The company issued a
statement Monday that said it was reviewing the FDA's latest advisory,
but is continuing to cooperate with the FDA and other federal and state
agencies looking into the outbreak.
"As we
have said, we will respect those public agencies' processes for
investigations and will not comment while they are under way," the
statement said.
Nearly all the 214 illnesses in the outbreak are fungal meningitis; two people had joint infections.
Last
week, federal health officials said 12,000 of the roughly 14,000 people
who received the steroid shots had been contacted. Those people
received methylprednisolone acetate injections at clinics in 23 states.
New
England Compounding, which custom-mixes ointments, painkillers and
other products, is licensed to sell in all 50 states. The FDA did not
say how many patients fall under the new advisory, or where the products
were shipped.
Symptoms of meningitis include
severe headache, nausea, dizziness and fever. The CDC said many of the
cases have been mild, and some people had strokes. Symptoms have been
appearing between one and four weeks after patients got the shots, but
CDC officials on Thursday warned at least one illness occurred 42 days
after a shot.
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