Pharmaceutical products contaminated with fungal meningitis can result in serious illness and sometimes fatal infections among all members of the population, says Alabama liability attorney Keith T. Belt.
Two other drugs made by the New England Compounding Center (NECC) appear to be involved in the fatal meningitis outbreak that has now claimed the lives of 19 people in as many states, the FDA announced Monday.
The FDA said today it is investigating one case of possible meningitis associated with an epidural injection of triamcinolone acetonide and two reports of fungal infection withAspergillus fumigatus in two transplant patients who were given cardioplegic solution made by the company. The solution is used to paralyze the cardiac muscle during open-heart surgery.
The new cases bring the total to 247, an increase of nine since Sunday, the agency said. Most of the cases are fungal meningitis, but the agency is also reporting that two involve peripheral joint infections.
At this point, an FDA release said, “the sterility of any inject-able drugs … and cardioplegic solutions produced by NECC are of significant concern. Patients who received these products should be alerted to the potential risk of infection,” the agency said.
So far, there have been no cases of infection linked to any ophthalmic drug made by the company that is either inject-able or used in eye surgery, “but FDA believes this class of products could present potentially similar risks of infection,” the agency said.
The outbreak has been linked to fungal contamination – with the mold Exserohilum rostratum — in three lots of preservative-free methylprednisolone acetate, mainly used to control back pain through spinal injections. All three lots of the drug have been recalled, along with all other products made by the Massachusetts company. All told, the company shipped more than 17,000 vials of the steroid.
In suspected cases, the CDC is recommending, clinicians should collect cerebrospinal fluid for culture and initiate both empiric antibiotic and anti-fungal therapy. The initial anti-fungal, the agency said, should be voriconazole (VFEND), preferably at a dose of 6 mg/kg every 12 hours for the duration of treatment, where possible. Clinicians should aim for a serum trough level of 2 to 5 mcg/ml. The drug can be given orally in patients with mild disease, the CDC is now recommending, but those with more severe illness should be started on the intravenous version of the compound.
The agency cautioned that both providers and patients should keep an eye out for potential adverse effects, including hepatic toxicity and neurotoxicity. Providers are also being told that they “should consider” giving liposomal amphotericin B in addition to voriconazole to patients with severe disease or those started initially on voriconazole monotherapy who either don’t improve or who get worse.
The agency is not recommending anti-fungal treatment for patients with symptoms but normal CSF.
Additional Information: Medpage