The Wall Street Journal reports that Westborough, Mass.-based drug-mixing pharmacy Ameridose LLC recalled its products on Wednesday following a message from Federal health inspectors stating that the company should improve its sterility testing. The Journal notes that Ameridose is a sister firm of New England Compounding Center, the pharmacy whose steroid injections have been linked to a deadly outbreak of fungal meningitis, which has sickened 356 people and killed 28. According to the article, Janet Woodcock, the head of the US Food and Drug Administration’s drugs division, said that the move was meant was a precautionary measure because Federal inspectors had determined that Ameridose’s manufacturing conditions could not assure sterility.
The New York Times notes that Ameridose “sells more than 2,200 blended drug products, including tranquilizers, anesthetics and antibiotics, according to its Web site. The drugs are pumped into both injectable and oral syringes, as well as intravenous medicine bags.” The Times mentions that although Ameridose is legally distinct from New England Compounding, both companies are owned by some of the same people, and Federal health investigators were concerned that Ameridose may have had some of the same business practices as New England Compounding.
Reuters states that Ameridose has asked its customers to quarantine all drugs purchased from the company while making arrangements to return the drugs to Ameridose.
The AP notes that Ameridose and NECC share the same founders, and AP adds that “Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, said she could not be specific about the problem at Ameridose.” The AP quotes Woodcock as saying only, “We found there was not adequate assurance of sterility in their sterile products.”
The Boston Globe, along with several other sources, refers to Ameridose as NECC’s “sister company.” The Globe also reports on the potential for a drug shortage, noting that the Massachusetts Hospital Association said the recall “will exacerbate an already troubling shortage of medications” stemming from the shutdown of NECC. The Globe adds that it is not known “when, or even if, Ameridose will resume operations.”
The Hill ”Healthwatch” blog reiterates that “no patient infections have been linked to Ameridose products.”
Death toll in meningitis outbreak rises to 29. Reuters reports that the death toll in the nationwide meningitis outbreak has reached 29, as the CDC announced Virginia’s third fatality Wednesday. The case count has risen to 368. ABC News adds that with nine joint infections, the total case count is 377.
Several other sources report on the recall of Ameridose products, including the CNN ”Chart” blog, the Boston Herald, the Tennessean, the Worcester Business Journal, HealthDay, WebMD, and MedPage Today.
USA Today examines “legal landscape” surrounding compounding pharmacies. USA Today looks into the “legal landscape” surround compounding pharmacies, saying that it is “littered with charges of negligence and misconduct by compounding pharmacies such as the one implicated in the nation’s ongoing meningitis outbreak, but they rarely result in tough punishments.” USA Today adds that “there’s almost no penalty for pharmacies that break the rules, and the people who run them simply continue with business as usual, sometimes with tragic results.”
Indiana attorney files lawsuit for local meningitis death. The Goshen (IN) News reports, “A wrongful-death lawsuit linked to a recent meningitis outbreak was filed in Elkhart County Superior Court No. 1 Tuesday.” The piece states that “according to the Goshen attorney representing the plaintiff, it’s believed to be the first wrongful-death lawsuit filed in Indiana relating to complications of fungal meningitis caused by a contaminated steroid injection.” As the story notes, the complaint “was filed against New England Compounding Pharmacy Inc., also known as New England Compounding Center, and its sister companies and subsidiaries, Ameridose LLC and Alaunus Pharmaceutical LLC, as well as the owners and officers of these companies.” The complaint was filed for damages including, but not limited to, last medical expenses, burial expenses, lost income, loss of love and services, and loss of consortium and punitive damages.
From the American Association for Justice news release.