November 1, 2012
Ameridose Issues Recall On Drugs Due To Meningitis Investigation
Lawrence LeBlond for redOrbit.com - Your Universe Online
Ameridose, a sister company to the US compounding facility responsible for a fungal meningitis outbreak that has now killed 28 people in 19 states, announced Wednesday it is invoking a voluntary recall of its products in cooperation with regulators.While the move could potentially ease the mind of many worried their steroidal injections could be contaminated, it is also contributing to a shortfall in the availability of certain drugs. In particular, the US Food and Drug Administration (FDA) and a number of hospitals are concerned about availability of several drugs for which Ameridose has been a major supplier, including those given as shots or IV drips.
Ameridose, based in Westborough, Massachusetts, was closed on October 10. The company said it has yet to receive any reports of problems with any of the drugs it is recalling, but said the FDA is calling on the company to improve its sterility testing processes.
Ameridose said in a statement it agrees that “the use of injectable products that are not sterile can represent a serious hazard to health.”
The company is now asking its customers to quarantine all drugs shipped by the company while it arranges for return. The Framingham, Mass.-based New England Compounding Company (NECC), which has been linked to all cases of the current fungal meningitis outbreak, had shipped 17,000 of its injectable doses to 23 states since May. Ameridose, has shipped its drugs nationwide, but has yet to have any reports of illnesses from its products.
The FDA said in October the “current production shutdown of Ameridose may impact supplies of certain drugs for some health care systems.”
Dr. Janet Woodcock, director of the FDA´s Center for Drug Evaluation and Research, told Reuters´ Sharon Begley that the agency “is aware that this recall might affect the availability of certain drugs“¦ 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 is currently talking with other drug makers to try to find a way to fill the gap left by the shutdown of Ameridose and its drug recall, said Woodcock, adding that it is also helping those whose manufacturing facilities have been curtailed by technical issues “get back in production.”
Two important drugs manufactured by Ameridose that face shortages are: sodium bicarbonate injections, used in emergency care to normalize the acidity of a patient's blood; and succinylcholine, a neuromuscular paralyzing agent used by anesthesiologists during surgery.
Medical facilities 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.
Drug shortages could seriously disrupt healthcare in the coming weeks to months if other pharmaceuticals cannot pick up the pace on production of these and other necessary medicines. A study by the American Hospital Association found that 82 percent of hospitals report patient treatment delays 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 NECC, and the FDA has heavily scrutinized the company´s facilities combing through every square inch of the company since its doors closed early last month.
NECC, which has been at the forefront of the fungal meningitis outbreak due to its unsanitary production practices, distributed some 17,000 contaminated injections to 76 medical facilities in 23 states since May 2012. Over the course of 4 months, roughly 14,000 of the contaminated injectables were used.
Since cases of fungal meningitis first started popping up in August and September, the FDA and the US Centers for Disease Control and Prevention (CDC) have been working diligently to bring it under control.
As of today (Nov. 1, 2012) the CDC is reporting 377 cases of fungal meningitis, 9 cases of joint infections, and 28 deaths. The number of deaths did stand at 29, however Virginia, which had reported three new deaths earlier Wednesday, said it could only confirm two of the deaths being linked to the meningitis outbreak.
The CDC is calling on anyone who received injections in any of the 23 states currently involved in the outbreak to report to their local hospital if they develop any sign or symptoms of meningitis. These symptoms, which can be severe and life threatening, include: headache, fever, dizziness, nausea, sensitivity to light, stiff neck, weakness or numbness, slurred speech and pain, and redness or swelling at the injection site.
Symptoms generally take more than a month, up to 42 days in the current outbreak, the CDC´s Dr. Benjamin Park, told ABC News.
“But we want to emphasize that we don't know what the longest will be,” he added, stressing that patients who received these injections should stay attuned to the subtle symptoms “for months.”
Fungal meningitis is diagnosed through a spinal tap, which draws cerebrospinal fluid from the spine that can be inspected for signs of the disease. Once detected, it can be treated with high doses of intravenous antifungal medications. Unlike bacterial meningitis, fungal meningitis is not transmitted from person to person and only people who received the steroid injections are known to be at risk.
In related news: NECC has hired Harris Beach PLLC, a NYC and Newark, NJ law firm 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 people with knowledge of the matter.