CDC says 13,000 patients could be at risk from tainted steroid made by Framingham company

US health officials on Monday said that 13,000 patients in 23 states, including Connecticut, Rhode Island, and New Hampshire, have been injected with a potentially tainted steroid treatment made by a Framingham pharmacy and linked to a national outbreak of meningitis.

The US Centers for Disease Control and Prevention gave its sweeping estimate of the reach of the crisis as it reported 14 new cases of the disease, and another death in Tennessee, which appears to be the hardest hit among the states where the rare and serious form of fungal meningitis has been confirmed.

“We know that 13,000 people received the injection,’’ said Jamila Jones, a public affairs specilialist for the CDC in Atlanta. “They received it at facilities across the country. They are at risk.’’


So far, 105 cases and eight deaths have been confirmed nationally, the agency said.

The steroid, called methylprednisolone acetate, was made by New England Compounding Center in Framingham, which voluntarily ceased operations Oct. 3 amid a widening probe of the treatment and its use at dozens of health care facilities from New Hampshire to California.

A spokesman for New England Compounding Center on Monday said the company would have no further comment on the matter.

On Saturday, the company voluntarily recalled 1,200 products made at its facility on Waverly Street. It posted a 71-page list of the products recalled, which includes some common drugs and medications, such as the pain reliever acetaminophen, blood-pressure medication clonidine, rubbing alcohol, and mouthwash.

“ This action is being taken out of an abundance of caution due to the potential risk of contamination, and in cooperation with an investigation being conducted by the Food and Drug Administration,
the Centers for Disease Control and Prevention, and the Massachusetts Board of Registration in Pharmacy,’’ the company wrote in a statement published on its website,

The recall followed an announcement by the US Food and Drug Administration on Oct. 5 that it was investigating an outbreak of meningitis among patients who had received an injection of the steroid in their spine to treat back pain. The FDA said fungal contamination was detected in foreign matter taken from a sealed vial of the steroid collected from NECC. The agency also recommended health care facilities and consumers not use any product made by the Framingham company.


According to the CDC, the steroid was shipped to 75 health care facilities in California; Connecticut; Florida; Georgia; Idaho; Illinois; Indiana; Maryland; Michigan; Minnesota; North Carolina; New Hampshire; New Jersey; Nevada; New York; Ohio; Pennsylvania; Rhode Island; South Carolina; Tennessee; Virginia; Texas; and West Virginia.

In New Hampshire, concern about a meningitis outbreak is growing. More than 200 patients treated at the Merrimack and Somersworth offices of Dr. O’Connell’s Pain Management Center received injections from mid-June until Sept. 27, Dr. Michael O’Connell said Monday night.

A handful of patients, who have complained of headaches, numbness and other symptoms of meningitis, are being observed in local hospitals, O’Connell said.

“We are watching them very carefully,’’ he said in an interview. “We are just at the beginning of this. If a contaminated medication with the fungus is injected, it could be a week or four weeks’’ before the disease is diagnosed.

Most cases and fatalities so far have been reported in the South and Midwest.

In Tennessee, 35 meningitis cases and four deaths, including one over the weekend, were confirmed. The high rate is likely linked to a large shipment of the treatment shipped to health care facilities there, Dr. John Dreyzehner, the state’s public health commissioner, said Monday.

“We received a disproportionate share of the NECC compound,’’ Dreyzehner said in an afternoon conference call with reporters. “It’s unfortunate, but that is indeed what happened.’’

After Tennessee, Virginia had the second-highest number of confirmed cases with 23, followed by Michigan, 21, Indiana, 11, Maryland, 5, Florida, 4, Minnesota, 3, North Carolina, 2, and Ohio, one, according to the CDC.


Dreyzehner said the outbreak was first identified in Tennessee by public health officials at the St. Thomas Outpatient Neurosurgery Center in Nashville, which received 2,000 vials of the steroid, more than any other facility in the state.

About 1,000 people in Tennessee have been identified as having received the treatment since June 27, Dreyzehner said. Over the weekend, the state sent public health nurses knocking on doors on patient’s homes to notify them that they may be at risk, if they were already not aware, he added.

“We have been very aggressive,’’ Dreyzehner said. “We intend to keep close tabs on these people . . . It’s important for people to realize that the period of exposure is over, but the period of risk [to develop meningitis] is not yet over. It will be some time before it is.’’

He said all remaining vials of the steroid have been removed, and sequestered, from health facilities across the state. US health officials still are investigating the cause of the outbreak, Dreyzehner said.

He said the agency contacted the Massachusetts Department of Public Health shortly after it identified the problem treatment. “We’ve enjoyed a positive, close working relationship with Massachusetts officials,’’ Dreyzehner said.

Massachusetts public health officials Monday said they would continue a vigorous review of the Framingham drug maker.

US Representative Edward J. Markey, a Democrat whose district includes Framingham, sent a letter to the FDA requesting a review of oversight and practices at compounding pharmacies, to ensure safety standards are met, according to a statement from his office.

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