More than 1,000 patients at Maine medical facilities have been treated with products that were recalled by a Massachusetts pharmacy after a steroid injection was linked to a meningitis outbreak that has killed 24 people and sickened hundreds more.

Officials from those facilities are stressing that the products they used have not been associated with the meningitis outbreak or any other illnesses, but a spokeswoman from U.S. Food and Drug Administration said Thursday that the agency is not certain the injectable steroid is the only contaminated product from New England Compounding Center.

State epidemiologist Dr. Stephen Sears said the tainted steroid injection was not shipped to any facilities in Maine, but 30 facilities in the state have received other products from New England Compounding Center, according to the U.S. Food and Drug Administration.

About of half of those facilities said Thursday that no patients have reported concerning symptoms. The other half either did not return phone calls or had no one available to comment.

The products from New England Compounding Center used by the Maine facilities include a vein treatment, an asthma test, numbing gels, eye drops and injections for pain, macular degeneration, lipodissolve and early-labor prevention.

The FDA has instructed facilities to notify patients who received an injectable product that came from the Framingham, Mass., pharmacy on or after May 21.

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Seven facilities reported notifying more than 1,000 patients, from five at MaineGeneral Medical Center in Waterville who received injections for floppy iris procedures to about 600 patients at Central Maine Medical Center in Lewiston, who used a kit to test asthma or received an injection for pain or other conditions, according to officials at those hospitals.

St. Joseph Hospital in Bangor is sending letters to 1,500 patients who may have been treated with medication for pain, nausea or fluid retention that came from New England Compounding Center, according to spokeswoman Bethany McKnight.

She said the hospital knows how many actually were treated with the products, but she did not provide that number.

Other facilities reached Thursday could not or would not provide numbers of patients notified, or used only topical treatments from New England Compounding Center. The FDA is not requiring facilities to contact patients treated with the pharmacy’s topical products, which include gels used for inflammation, numbing and nausea.

All products from New England Compounding Center, however, are included in the recall. The FDA instructed facilities to sequester the products until given further instruction.

In interviews and letters to patients, officials from the facilities have emphasized that the products they used have not been associated with any illnesses.

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“I’m not worried at all about our patients,” said Dr. Stewart Turner of Kittery Ophthalmic Consultants, which used an injection to treat macular degeneration from New England Compounding Center.

Turner said an eye infection would have presented itself within 48 hours of the injection, and that time period has long passed.

Dr. Frank Lavoie, chief operating officer for Southern Maine Medical Center in Biddeford, also said he believes that hospital’s patients who were treated with an eye drop used in cataract surgery are at very low risk for infection, because no illnesses associated with that product have been reported.

“Should risk have manifested itself, it would already be present,” he said.

Sarah Clark-Lynn, a spokeswoman for the FDA, said the agency can’t guarantee that other products have not been contaminated. She said the FDA is concerned about all of New England Compounding Center’s products, but more about some than others. She declined to be more specific.

Clark-Lynn said she couldn’t comment on whether products aside from the steroid injection have been tested, because that information is part of an ongoing investigation.

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Sears, the state epidemiologist, said he was echoing the words of the FDA when saying that the scope of the recall represented an “abundance of caution.”

On the basis of information from the federal government, Sears said, “there does not appear to be significant risk.”

Sears said the Maine Center for Disease Control and Prevention received the list of facilities with products from New England Compounding Center last week and contacted them to make sure they knew they had recalled products. Most did, he said.

Dr. Sheila Pinette, director of the Maine CDC, said, although no patients in Maine were given the steroid associated with the outbreak, patients still could still show up in hospital emergency rooms with symptoms of fungal meningitis, because Maine has a lot of out-of-state visitors that may have been exposed elsewhere.

“Providers need to be on the lookout for any symptoms, and we’re helping educate them,” she said.

Portland Press Herald staff writer Eric Russell contributed to this report.

 


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