FDA: Seventy-five Mass. doctors and facilities received drugs from New England Compounding
Seventy-five Massachusetts doctors, hospital facilities, eye clinics, and rehabilitation centers received drugs in recent months produced by the New England Compounding Center, the Framingham pharmacy under investigation for producing tainted injections linked to nearly 300 cases of fungal meningitis in 16 states, and 23 deaths.
These health providers were listed on the FDA website Monday but later in the night the agency pulled the list, saying it had found technical problems and “the data are incorrect.”
None of the Massachusetts facilities is thought to have received injectable steroid, methylprednisolone acetate, from the batches that apparently caused the infections, and federal officials have said there is no clear link between infections and other New England Compounding products.
But the US Food and Drug Administration last week asked providers to contact patients who received other injectable medications produced since May 21 by New England Compounding, which has been shuttered.
In a sample outreach letter, the agency stressed that the additional patient notification was being made “out of an abundance of caution.” The recommendation came after a heart transplant patient who had received a drug meant to temporarily stop the heart from beating during surgery contracted a fungal infection, and after another patient developed signs of meningitis after getting a second type of steroid for back pain. Both medications came from New England Compounding.
“A lack of sterility in the facility means that any product made in that facility may be contaminated,” an FDA spokeswoman said in an e-mail Friday, but added that “there may be other explanations” for these patients’ infections.
The cardioplegic product and solutions that are injected into patients’ eyes are “of particular concern” because of the manner in which they are used, the spokeswoman said.
The FDA on Monday released the full list of New England Compounding customers. It contains 1,279 facilities and physicians nationwide, including 18 Massachusetts hospitals and dozens of smaller centers in the state focused on eye care, plastic surgery, and treatment of pain.
People who received injections from the center should be familiar with the symptoms of meningitis, including fever, headache, stiff neck, nausea, and sensitivity to light.Liz Kowalczyk of the Globe staff contributed to this report. Chelsea Conaboy can be reached at email@example.com. Follow her on Twitter @cconaboy.
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|White Coat Notes covers the latest from the health care industry, hospitals, doctors offices, labs, insurers, and the corridors of government. Chelsea Conaboy previously covered health care for The Philadelphia Inquirer. Write her at firstname.lastname@example.org. Follow her on Twitter: @cconaboy.|
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