CDC sounds warning on more tainted NECC drugs

Dec 4, 2012 (CIDRAP News) – Further testing on three more products from New England Compounding Center (NECC) has turned up extensive contamination in three more products, and federal officials are asking healthcare workers to be alert for more infections, though they stopped short of calling the situation an outbreak.

In a Health Alert Network (HAN) update yesterday, the US Centers for Disease Control and Prevention (CDC) said some of the organisms found in unopened vials of NECC's betamethasone, cardioplegia, and triamcinolone solutions can cause disease in humans.

It said the agency has received reports of infections in patients who have received the products, but so far none have been lab-confirmed.

Betamethasone and triamcinolone are steroids, and cardioplegia solution is used to stop the heart during cardiac surgery. The three products are already subject to a recall of all NECC products in the wake of fungal infections that have been linked to the company's methylprednisolone acetate injections.

In mid October the CDC warned clinicians about possible meningitis cases in patients who received triamcinolone and cardioplegia solution. On Nov 1 federal officials announced they had found Bacillus species in the company's betamethasone and cardioplegia solution and were investigating reports of possible infections and awaiting the results of tests for fungal organisms.

According to yesterday's HAN alert, fungal testing also turned up Aspergillus tubingensis, A fumigatus, Cladosporium species, and Penicillium species. The contamination appeared in three lots of injectable betamethasone, three lots of triamcinolone, and one lot of cardioplegia solution.

The CDC said that although some of Bacillus species are known human pathogens and A fumigatus can cause disease, the clinical implications of the other organisms are not known. It urged clinicians to consider the organisms in the work-up of patients with symptoms who were exposed to the drugs.

Though some of the patients who were exposed to the three other products had evidence of meningeal inflammation, lab tests haven't confirmed the findings and the data do not support evidence of an outbreak linked to the other three products.

Yesterday the CDC said 541 fungal infections and 36 deaths have been linked to a multistate outbreak caused by contaminated methylprednisolone acetate injections from NECC.

See also:

Dec 3 CDC HAN update

CDC background on other products from NECC

Dec 3 CIDRAP News Scan "Steroid-linked fungal infections climb to 541"

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