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Prodded by FDA, Westborough firm to recall all its drugs

The Ameridose building in Westborough.

Marshall Wolff/Metrowest Daily News/AP

The Ameridose building in Westborough.

Ameridose LLC, the sister company of the Framingham specialty pharmacy blamed for the deadly outbreak of fungal meningitis in 19 states, agreed to recall all its drugs Wednesday after federal regulators raised questions about the company’s safety tests.

The Westborough company supplies more than 3,000 hospitals nationwide, and several health officials warned that the recall could worsen shortages of some injectable drugs, includ­ing ones used during surgery and to resuscitate patients. Some hospitals are discussing the possibility of delaying operations.

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The US Food and Drug ­Administration said it recommended the recall of more than 2,000 Ameridose products due to shortcomings spotted during an ongoing inspection.

Investigators at Ameridose’s facilities did not find “an adequate assurance of sterility in the manufacturing of their sterile products,’’ said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. In a telephone interview, she said that the recall was precautionary and that the agency “is not aware of any ­reports of patient infection” tied to Ameridose drugs.

The FDA said there is no need for doctors to check in with patients who have already received Ameridose products, and state regulators said they have not seen any evidence of impurities in the drugs so far.

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Ameridose has the same owners and some other ties to New England Compounding Center, the Framingham company whose steroid injections have sickened hundreds of people. But Ameridose is considerably larger: It has 650 employees, while New England Compounding has 50.

So far, 377 people have ­developed meningitis or joint infections after receiving steroid injections made by New England Compounding, accord­ing to the US Centers for Disease Control and Prevention. At least 28 have died.

Ameridose, which temporarily suspended its operations three weeks ago to give inspectors time to review its operations, said it agreed to a voluntary recall “out of an abundance of caution” after the FDA told Ameridose that it was not satisfied with the company’s sterility testing of its drugs.

“Customer confidence is paramount to its business,” the firm said in a statement, adding that it has shipped 70 million units of drugs since its founding in 2006.

The firm’s agreement to suspend operations expires Monday, and it was not clear if it will be extended. The state Department of Public Health said Wednesday that the agreement “is under review,” and the state hospital association said the ­recall “calls into question when, or even if, Ameridose will ­resume operations.”

The recall and the potential long-term loss of a major drug maker could further strain supplies of certain crucial injectable medications, the FDA and hospitals warned. Ameridose supplied hospitals with drugs in prefilled syringes and individual intravenous bags.

Woodcock cited succinylcholine, an anesthetic, and sodium bicarbonate, which has many uses, including emergency resuscitation of ­patients. She said the FDA is working with other manufacturers of injectable drugs to boost production and is trying to expedite applications for new generic drug makers to help fill the gap.

“We will have to see how this goes,’’ Woodcock said. “We will do everything possible to try to mitigate these shortages.’’

Baystate Health, the largest hospital system in Western Massachusetts, has already ­noticed an “unprecedented” shortage of drugs used in operating rooms, including some used to control blood pressure, because of the shutdown of Ameridose and New England Compounding, said Gary Kerr, chief pharmacy officer of the 783-bed system.

Baystate, which relied on Ameridose for 18 drugs, was forced to start making the drugs in its own pharmacy a few weeks ago, after Ameridose suspended operations, Kerr said.

“I have pharmacists that are working hour to hour and day by day,” said Kerr, who is also incoming president of the ­Massachusetts Society of Health-System Pharmacists. “These are people not going on coffee breaks or lunch breaks. This is exceptionally challenging.”

Even though Ameridose has not shipped new products for weeks, industry executives warned that the recall could ­increase pressure on hospitals that have to round up Ameridose products they already purchased and find alternatives.

“Hospital teams are working longer and harder hours, but it’s not sustainable in the long haul, regardless of the size of the hospital,” said Tim Gens, ­executive vice president of the Massachusetts Hospital Association.

He said hospitals are exploring long-term possibilities, such as delaying elective surgeries and other procedures. He said the association may look into whether larger hospital pharmacies with extensive compounding production capabilities may be able to supply smaller hospitals.

But Gens said current state regulations restrict hospital pharmacies from sharing products because of safety and quality concerns. “Even if it’s feasible, do hospitals that have that ability really have the capacity to deal with that beyond their own needs?” Gens said.

Regulators have found problems with Ameridose in the past.A 2008 FDA inspection noted several issues, including that it did not fully test all the lots of its drugs and shipped some lots before getting results of sterility tests. Shortly after the inspection, Ameridose recalled a painkiller, belatedly discovering it was too potent.

In addition, some former workers recently told the Globe they had concerns about the company’s safety procedures, including one who said the company refused a co-worker’s request to halt a production line when he could not find ­labels for bags of drugs.

The recall focuses additional attention on Sophia Pasedis, Ameridose’s vice president of regulatory affairs and a member of the state pharmacy board. Pasedis is listed as manager of the firm’s pharmacy operations with the Massachusetts Board of Registration in Pharmacy, and she is the one ulti­mately responsible for the company’s testing procedures under state licensing rules.

The administration of Governor Deval Patrick has already been pushing Pasedis to resign, saying a review of the board's minutes “calls into question” whether she always recused herself from votes involving New England Compounding. Pasedis has told state officials she believes she did recuse herself, and her attorney has said she has no plans to resign. Her term expires later this month.

Ameridose said it was notifying customers of the recall by fax and arranging for product returns. Customers with questions were directed to call 888-820-0622 during business hours.

Chelsea Conaboy of the Globe staff contributed to this report. Liz Kowalczyk can be reached at kowalczyk@globe.com; Kay Lazar at klazar@globe.com; and Todd Wallack at twallack
@globe.com
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