Kyle Parker, director of the Ohio Board of Pharmacy, announced on Wednesday the summary suspension of the license of New England Compounding Center of Framingham, Mass.
In a statement, the state pharmacy board said the suspension was made after discussions with the Ohio Department of Health. The pharmacy board found “clear and convincing evidence that the continuation of New England Compounding Center’s professional practice presented a danger of immediate and serious harm to others,” the statement said.
The Centers for Disease Control and Prevention Nationally said all of the people sickened received the epidural steroid injections of allegedly contaminated methylprednisolone acetate compounded by the Massachusetts pharmacy, which has ceased operations since the outbreak was identified. The pharmacy has voluntarily recalled all of its products, including the injectable steroid.
Ohio has recorded one rare form of fungal meningitis infection, an unidentified 65-year-old male. The drug was administered to 424 patients through four pain management clinics in Dublin, Marion and Ohio, according to state health officials.
The CDC and Food and Drug Administration are investigating the outbreak and the compound pharmacy. The Ohio Board of Pharmacy is also investigating allegations against the pharmacy.
On Tuesday, members of the U.S. House of Representatives’ Energy and Commerce Committee asked for CDC and FDA briefings on the outbreak. The members, led by Chairman Fred Upton, R-Mich., wrote, “The committee has a long bipartisan history of conducting drug safety oversight and is very concerned about these recent developments. We intend to learn more from the FDA, CDC, and others who may provide insight into the details surrounding this outbreak and the prevention of future outbreaks.”
No new Ohio infections have been identified so far this week, said Tessie Pollock, spokeswoman for the state health department. “With the level of surveillance we’re doing, that’s surprising,” she said.
Public health workers have notified 410 of the 424 Ohio residents who received the recalled steroid, she said. “We’ve knocked on doors and nobody lives there, or the address was incorrect,” she said, adding it was doubtful the 14 people who have not been found will be reached.
Health workers will continue to keep in touch with people who received the drug, Pollock said.
”This needs to be something that’s ongoing, because we don’t know exactly how long the incubation period is for this type of meningitis, so health workers need to be in touch with people, and they need to keep checking on them,” she said.
The CDC is advising that not all patients who received the medicine will become sick. Symptoms that should prompt patients to seek medical care include fever, new or worsening headache, neck stiffness, sensitivity to light, new weakness or numbness, increasing pain, redness or swelling of the injection site.
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