A sister company of the compounding pharmacy at the heart of the fungal meningitis outbreak that has now claimed 29 lives is voluntarily recalling all its products.
The move is an "expansion of our cooperation" with the FDA and the Massachusetts Board of Registration in Pharmacy, Ameridose, of Westborough, Mass., said in a statement today.
The company, which shares ownership with the New England Compounding Center, said it does not know of any adverse reactions from its products and there has been no evidence of impurities. Instead, the company said, the move is being undertaken out of an "abundance of caution."
Meanwhile, the CDC has reported an additional 14 cases and one death related to the preservative-free methylprednisolone acetate made and distributed by the New England Compounding Center.
With the new fatality, in Virginia, the death toll now stands at 29 in the 19 affected states, the CDC said.
Tennessee has reported the most deaths at 11, followed by Michigan with seven. Virginia, Florida, and Indiana have each reported three deaths, and Maryland and North Carolina have had one each.
All told, health officials have identified 368 cases of fungal meningitis, stroke as a result of presumed fungal meningitis, or other central nervous system-related infection, as well as nine cases of peripheral joint infection.
Ameridose, which makes ready-to-use admixed preparations for hospital pharmacies, stopped production on Oct. 10, amid the growing scandal surrounding its sister company.
The FDA said at the time it was working with the company to make sure its products were safe.
The company said today that, as a result of the agency's continuing investigation at the Westborough plant, "FDA has notified Ameridose that it will be seeking improvements in Ameridose's sterility testing process."
The FDA said in a statement that it has "concerns about a lack of sterility assurance" for Ameridose products.
But it also said there's no need for healthcare professionals to take any action beyond collecting the recalled products and sending them back to the company.
In particular, "at this time ... healthcare professionals do not need to follow up with patients who received Ameridose products," the agency said.
The meningitis outbreak began after the New England Compounding Center shipped three separate lots of the steroid - some 17,000 vials - to pain clinics in 23 states, where it was mainly used in epidural injections to control chronic back pain.
Unopened vials from two of the lots have now been shown to be contaminated with the black mold Exserohilum rostratum, and testing is continuing on the third lot, the CDC reported.
The agency said its labs have confirmed that 52 patients with fungal meningitis have Exserohilum rostratum in clinical specimens. Two other patients have a lab-confirmed fungal infection, one with Aspergillus fumigatus and one with Cladosporium.
The steroid was recalled Sept. 26 and the manufacturer followed up by recalling all of its products Oct. 6, so health officials are confident no new infections are likely since the meningitis in these cases is not contagious.
Source: Med Page Today-Oct. 31, 2012 at