The Boston-area facility linked to 170 cases of fungal meningitis, which has killed 14 people, may have violated licensing requirements, a health official says.
The New England Compounding Center in Framingham, Mass., produced about 14,000 doses of the injectable steroid methylprednisolone acetate used to treat back and joint pain. The facility was shipping thousands of doses of the steroid alone to at least 23 states, but Dr. Madeleine Biondolillo -- director of the Department of Public Health's Bureau of Health Care Safety and Quality at the Massachusetts Department of Public Health -- said her agency was not authorized to monitor volume of doses.
Compound pharmacies are designed to produce individual drugs by prescription and therefore are regulated by the states. They are not to act as drug manufacturers, which are regulated by the federal Food and Drug Administration, said.
"We urge Congress to act quickly to address the need for new laws at the federal level," Biondolillo told reporters in a telephone news conference. "The organization chose to apparently violate the licensing requirements under which they were allowed to operate."
Deborah M. Autor, deputy commissioner for Global Regulatory Operations and Policy at the FDA, said the New England Compounding Center assured federal agencies in writing it was in compliance with all state and federal laws.
Dr. J. Todd Weber of the U.S. Centers for Disease Control and Prevention said the CDC had contacted almost 90 percent of the estimated 14,000 people who had received an injection of the steroid.
"We want to make sure patients understand symptoms they need to watch for -- new or worsening headache, fever, sensitivity to light, stiff neck, numbness in any part of the body, slurred speech or pain, redness or swelling at the injection site -- and to seek medical care imminently," Weber told reporters. "Although the onset of symptoms appears to be one to four weeks from the date of the injection, we know fungal infections can be slow and this can take months for symptoms to present."
Once fungal meningitis is confirmed, patients can get two anti-fungal drugs, but they are very strong and some patients might have difficultly taking them for a long time. It is possible the clinical recommendations for treatment might change over time, Weber said.
The source of the fungus -- which causes the non-contagious fungal meningitis, and was identified in about 50 vials of the steroid from the New England Compounding Center -- has not yet been identified, Autor said.
The CDC said Tennessee was the first state to identify the fungal meningitis and has the most cases at 49 and six deaths, followed by 39 cases and three deaths in Michigan; 30 cases and one death in Virginia; 21 cases and one death in Indiana; 13 cases and one death in Maryland; seven cases and two deaths in Florida; three cases in Minnesota; three cases in Ohio; two cases in North Carolina; two cases in New Jersey; and one case in Idaho.
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