* Ameridose says FDA asked it to improve sterility testing
* FDA concerned about availability of several drugs
By Sharon Begley
BOSTON, Oct 31 (Reuters) - Ameridose, a sister company of the U.S. pharmacy linked to a meningitis outbreak that has killed 29 people, announced on Wednesday a voluntary recall of all its products, a move to cooperate with regulators that could nevertheless create shortages of some drugs.
In particular, the U.S. Food and Drug Administration and a number of hospitals are concerned about the availability of several drugs for which Ameridose has been a major supplier, including those given as shots or intravenous drips or used during surgery.
The Westborough, Massachusetts-based company, which was closed on Oct. 10, said it had not received any reports of adverse reactions to the products it is recalling but that the FDA has asked it to improve its sterility testing processes.
“Ameridose and FDA agree that the use of injectable products that are not sterile can represent a serious hazard to health,” the company said in a statement, adding that it shipped its medications nationwide.
The company asked its customers to quarantine Ameridose drugs while they arrange to return them to the company.
Earlier in October, the FDA said, “The current production shutdown of Ameridose may impact supplies of certain drugs for some health care systems.”
The FDA “is aware that this recall might affect the availability of certain drugs,” Dr. Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, told Reuters. “This is a company that produces and ships a lot of sterile injectables. We are trying to mitigate the effects (of the Ameridose recall) on drug supplies.”
The FDA has already spoken with other manufacturers about filling the supply gap left by the shutdown of Ameridose and now the recall of its products, Woodcock said, including helping those whose manufacturing facilities have been curtailed by technical or other issues “get back into production.”
Ameridose has been a major manufacturer of sodium bicarbonate injections, for instance, which are used in emergency care to normalize the acidity of a patient’s blood. It also produced succinylcholine, a neuromuscular paralyzing agent used by anesthesiologists during surgery. Hospitals could face shortages of both drugs, Woodcock said.
Those in Massachusetts, which have been major Ameridose customers, warned that the recall “will exacerbate an already troubling shortage of medications that has arisen due to the permanent closure” of the compounding pharmacy blamed for the meningitis outbreak and the temporary closing of Ameridose, the Massachusetts Hospital Association said in a statement.
It added that drug “shortages are prevalent,” especially of generic sterile injectables including cancer drugs and anesthetics. In a study by the American Hospital Association, 82 percent of hospitals said patients had experienced delays in treatment due to drug shortages; more than half said the shortages prevented them from providing patients with recommended treatment.
Ameridose is owned by the same people as New England Compounding Center (NECC), the compounding pharmacy whose injectable steroids turned out to be contaminated with fungus and are blamed for 368 cases of fungal meningitis. FDA inspectors have been combing through Ameridose’s facilities since the company was closed.
Separately, NECC hired Harris Beach PLLC, a law firm with offices in New York City and Newark, New Jersey, to lead its defense against civil claims, according to a filing on Wednesday with the United States Judicial Panel on Multidistrict Litigation.
NECC’s defense will be led by high-profile corporate defense attorney Frederick Fern, a specialist in medical tort litigation, according to two people with knowledge of the matter. According to the law firm’s website, Fern has represented many pharmaceutical and medical device companies, including in a large case involving the diet-drug combination called fen-phen, and is also a registered pharmacist.