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November 03. 2012 11:37PM

New drug recall, new round of concern

As a nationwide drug recall triggered by a deadly fungal meningitis outbreak expanded to a second Massachusetts pharmaceutical company last week, public health officials here are asking providers to monitor patients for illnesses that could be related to those medications.

The New Hampshire Health Department is also asking laboratories to check their records for evidence of potential contamination that may have been missed before the outbreak came to light.

On Wednesday, Ameridose LLC announced a voluntary recall of more than 2,000 unexpired products, asking providers to quarantine them and return them to its Westborough, Mass., facility.

An FDA news release says that action was taken after preliminary results of an ongoing inspection "raised concerns about a lack of sterility assurance for products produced at and distributed by this facility."

Ameridose officials could not be reached for comment Friday. On its website, the company stated there have been no reports of adverse effects and no "impurities" have been identified in its products by either the company or the FDA.

However, the statement said, "Ameridose and FDA agree that the use of injectable products that are not sterile can represent a serious hazard to health and could lead to life-threatening injuries and/or death."

On Friday, Ameridose and a sister company, Alaunus Pharmaceutical LLC, signed an agreement with the Massachusetts Board of Registration in Pharmacy to remain closed through Nov. 19.

The list of Ameridose products recalled includes many medications commonly administered in hospitals, such as antibiotics, painkillers, anticoagulants, saline solutions and multi-vitamins.

The state Department of Health and Human Services previously released a list of 24 providers that received injectable drugs from New England Compounding Center (NECC). Injections made by the Framingham, Mass., company have been linked to fungal infections that to date have sickened more than 400 and killed 29 people in 19 states.

DHHS directed providers to contact all patients who received injections of NECC products shipped since May.

Long list of drugs

Getting a list of New Hampshire facilities that received the products recalled by Ameridose may not be so easy, according to Dr. Sharon Alroy-Preis, state epidemiologist.

She said she asked the FDA for such a list: "The answer was: We will try to work on this, but the list will be very long."

On Thursday, the state Health Department sent an alert to hospitals, city health departments, physicians and, through the New Hampshire Board of Pharmacy, pharmacies "to let them know that all Ameridose products have been recalled and why, to discontinue the use of all of them and to return them to Ameridose for testing," Alroy-Preis said.

And while providers were not asked to notify patients at this time, the state is advising them: "When someone is coming in with symptoms, to keep that in mind and to check if that person may have received an Ameridose product...."

There is no evidence currently of contamination or illness tied to any Ameridose products, she stressed. "That's somewhat reassuring."

Kathy Bizarro, executive vice president of the New Hampshire Hospital Association, said its members have been notified of the latest recall.

Bizarro noted one concern is that some of the recalled products were already on a list of critical drug shortages. "And this certainly will compound that," she said.

The FDA has said it is working with alternative manufacturers "to maintain supplies of these life-saving drugs."

Susanna Whitcher, vice president of public affairs and marketing for Elliot Health System, said the Manchester hospital has removed eight Ameridose products from its inventory since the recall.

NECC came under federal investigation because patients became ill, Alroy-Preis noted; that's not the case with Ameridose. The FDA began investigating Ameridose because it shares "common management" with NECC, an agency news release stated.

However, Alroy-Preis acknowledged this is the same kind of broad, "voluntary" recall that NECC issued after the initial cases of meningitis were linked to its injectable steroids. The company has since shut down and has lost its pharmacy licenses in several states, including New Hampshire.

"And largely time will tell if this is heading toward the same ending because everything is really based on culturing vials or testing vials, which takes time," Alroy-Preis said. "So it's hard to know whether it's heading toward the same type of road, but we are planning and preparing . for the worst."

Bacterial contamination

In a related development, the Centers for Disease Control and Prevention last week announced that ongoing testing has found bacteria in two additional drugs made by NECC.

That prompted the health department here to ask New Hampshire laboratories to review their records for evidence of bacterial contamination.

"I think it brings to our awareness that it's not just fungi that we're talking about; now we have evidence of bacteria," Alroy-Preis said.

DHHS is asking all labs here to review records dating back to April to see whether any cultures from sterile body sites (such as spinal fluid) showed the presence of bacillus, the type of bacteria investigators found in the NECC drugs.

Evidence of bacteria in a laboratory culture would not ordinarily have triggered alarm, Alroy-Preis said, since it's ordinarily not associated with human illness. But given the broadening concern about NECC products, "it's a different story," she said.

"They're checking their records to see if there have been bacillus growth, and in cases that there were, they're reporting this to us so we can follow up to see if that patient . had a procedure in which they could have gotten an NECC product," she said.

As for the Ameridose recall, Alroy-Preis said without a list of which drugs went to which providers, it's difficult to advise patients who recently had medical procedures.

"We don't yet have proof that those vials were contaminated, that there is illness associated with them," she said. "But if someone is not feeling well, has fever, has symptoms that they cannot really explain and are unusual for them, and they may have received an Ameridose product, they should be evaluated."

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Shawne Wickham may be reached at swickham@unionleader.com.


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