More infections, questions as fungal meningitis outbreak worsens, widens

Health officials believe they may not have seen the worst of the deadly fungal meningitis outbreak linked to a contaminated steroid injection drug.

According to a Reuters report, the Centers for Disease Control and Prevention have confirmed more than dozen new infections of fungal meningitis early this week among people who received a contaminated Methylprednisolone Acetate injection at one of more than 70 health care clinics nationwide. There have now been 231 confirmed cases of fungal meningitis and 15 deaths linked to this epidural steroid injection.

One official from a Tennessee hospital that’s seen the highest volume of these cases speaking to Sunday morning talk shows said this likely is only the beginning of the outbreak and that hundreds more people could be infected from this contaminated drug. Remaining at the center of the outbreak is New England Compounding Center, a Framingham, Mass., company that manufactured and distributed at least 14,000 vials of the injectable drug.

NECC is a compounding lab that routinely accepts already-approved prescription drugs and drug ingredients and mixes or compounds them for other applications, like the Methylprednisolone Acetate injection. Methylprednisolone Acetate is commonly prescribed in the treatment of back pain and inflammation. NECC, like other compounding labs across the country, is not subject to Food and Drug Administration regulations, just state law but as this deadly outbreak of fungal meningitis widens, the company finds itself at the center of both state and federal investigations.

The latest developments in those investigations are focusing on the possibility that other drugs the company produces and distributes may also be carrying the same risks as its Methylprednisolone Acetate injections. Testing is underway on the myriad other products that were included in a series of recalls issued by the company since Oct. 3, that also included three Lots of Methylprednisolone Acetate vials.

Since learning of the fact that the contaminated Methylprednisolone Acetate vials were responsible for the fungal meningitis cases already reported, state and federal health officials alongside representatives of the pain centers where the affected drug was sent have been busy contacting up to 14,000 people who were put at risk of developing the rare infection, notifying them of the potential for serious side effects and complications, some of which can be deadly. That information campaign has also included notifying healthcare professionals and physicians of some background information and clinical guidance for dealing with victims of the outbreak.

The fact that more NECC drugs could be contaminated with the same deadly fungus that’s affected Methylprednisolone Acetate vials could result in more work for health officials.

NECC is also facing questions related to potential licensing violations. The company is only permitted to manufacture Methylprednisolone Acetate on an on-demand basis. A prescription for each vial must be verified before this pharmacy company can manufacture and distribute it. Due to the widespread nature of the outbreak and the amount of vials affected by the recalls, it is likely NECC broke the law in the manufacture of these drugs.

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