Two more drugs from a specialty pharmacy linked toa meningitis outbreak are now being investigated, U.S. health officials said,as they urged doctors to contact patients who got any kind of injection fromthe company.
The New England Compounding Center of Framingham,Massachusetts, has been under scrutiny since last month, when a rare fungalform of meningitis was linked to its steroid shots used mostly for back pain.
Monday's step by the Food and Drug Administration followedreports of three new infections. One is a report of a possible meningitisillness in a patient who got a spine injection of another type of steroid madeby the company. The agency also learned of two heart transplant patients whogot fungal infections after being given a third company product during surgery.
The illnesses are under investigation, and it's verypossible the heart patients were infected by another source, FDA officialscautioned. They did not say whether the meningitis case involved a fungalinfection or where three infections occurred.
As of Monday, the current outbreak has sickened 214 people,including 15 who have died, in 15 states. For weeks, officials have been urgingdoctors to contact patients who got shots of the company's steroidmethylprednisolone 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 latershut down operations and recalled all the medicines it makes.
The FDA on Monday expanded its advice to doctors to contactall patients who got any injection made by the company, including steroids anddrugs used in eye surgery as well as heart operations. The agency said it tookthe step "out of an abundance of caution" as it investigates the newreports involving the heart surgery drug and the second steroid, calledtriamcinolone acetonide.
The company issued a statement Monday that said it wasreviewing the FDA's latest advisory, but is continuing to cooperate with theFDA and other federal and state agencies looking into the outbreak.
"As we have said, we will respect those publicagencies' processes for investigations and will not comment while they areunder way," the statement said.
Nearly all the 214 illnesses in the outbreak are fungalmeningitis; two people had joint infections.
Last week, federal health officials said 12,000 of theroughly 14,000 people who received the steroid shots had been contacted. Thosepeople 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,who is investigating the outbreak with state officials, did not say how manypatients fall under the new advisory, or where the products were shipped.
Symptoms of meningitis include severe headache, nausea,dizziness and fever. The Centers for Disease Control said many of the caseshave been mild, and some people had strokes. Symptoms have been appearingbetween one and four weeks after patients got the shots, but CDC officials onThursday warned at least one illness occurred 42 days after a shot.