Alaskan patients who have been injected with New England Compounding Center (NECC) products in the last five months have been put on alert to watch for symptoms of fungal Meningitis, as questions of product sterility have led the FDA to cast a "wide net" and recall all NECC products produced after May 21, 2012.
There are no identified cases in Alaska; the only product definitively linked to the meningitis outbreak is NECC's methylprednisolone acetate steroid, none of which was distributed to the state. Yet medical centers across Alaska have been instructed to contact patients that received other products produced by the Massachusetts pharmacy, as sterility of "all injectable drugs produced by NECC are now of concern" in the nationwide outbreak, according to Alaska state health officials.
The "wide net" now being cast by the FDA is due to two other cases of fungal infection possibly stemming from injections of other NECC products, said Dr. Joe McLaughlin, the Alaska state epidemiologist.
According to the FDA's website, a patient with possible meningitis has potentially been identified with an epidural injection of a different NECC product, triamcinolone acetonide. In a separate case, a transplant patient with Aspergillus fumigatus who was administered a cardioplegic solution during heart surgery may also be related to NECC sterility concerns. However, the FDA states that "there may be other explanations" for the Aspergillus infection. Investigation into these cases is ongoing, and no location for these cases has been released.
'An abundance of caution'
Dr. McLaughlin says that the CDC is currently doing "lots of testing to determine whether other medicines were tainted in any way." He stresses that none of the injectable product with a confirmed link to meningitis was distributed to Alaska medical centers. That's "really good news," he says.
The FDA's instruction to contact all patients who received injections from NECC products is out of "an abundance of caution," state officials say.
Based on federal guidance, at over 800 Alaskans identified by the state Department of Health and Social Services need to be contacted. They were treated at the following centers or clinics:
Spine Center LLC is contacting every patient that has come through their doors since May 21, around 650 people total. They decided that the quickest way to get in touch with their patients is through letters being mailed out on Wednesday, as most people live in the Anchorage bowl. They are also fielding phone calls, and had already talked to around 30 people by noon Wednesday. Administrator Bruce Jayne says "we want to make sure our patients know we're looking out for their best interests." Nobody who has called has reported symptoms.
The Surgery Center of Fairbanks, which is contacting 26 patients who had received NECC products as part of pain management treatment, is both calling and sending letters.
No action necessary
Both clinics had quarantined all NECC products by the time the FDA contacted them about removing said products from their shelves. The FDA stopped by the Spine Center in Anchorage to see the pulled products, and they called the Surgery Center in Fairbanks. "I was two days ahead of them," Surgery Center Administrator Russ Uhrmacher said, noting that he had pulled NECC products from the shelves immediately on notification.
For now, the quarantined NECC products remain at the clinics, as they await instruction from the CDC on how to send them back.
Dr. McLaughlin also notes that "no action is necessary for people who don't have symptoms." Folks who receive a letter in the mail do not need to contact a health provider if they don't have the noted symptoms. He also wants to make sure that people "be aware of this situation, but not overly concerned."
The table below shows how many patients were being contacted per clinic:
As the number of cases across 15 states climbs to 247 with 19 reported fatalities, Congressional leaders have called for answers, although no hearings have been scheduled on the issue. NECC shipped more than 17,000 vials from three suspected lots of steroids to 24 states. On Oct. 6, 2012, NECC issued a recall of all its products.
NBC News reports that FDA enforcers raided NECC's facility in Framingham, Mass., on Tuesday night. They had earlier cited concerns about sterility of the pharmacy's products after inspecting the facility, although both the FDA and Massachusetts officials have said they didn't have powers to stop the pharmacy; both have asked Congress to clarify their powers through legislation.
Ed Markey, D-Mass., has called on the Department of Justice to investigate what appears to be the illegal sale of controlled substances that the company was not registered to manufacture, including morphine, ketamine and cocaine, noting that those drugs are listed in the recall notice.
Symptoms may not develop for a month or longer
Meningitis is an infection that causes the swelling of protective membranes covering the brain and spinal cord. The Centers for Disease Control and Prevention notes that meningitis is most often caused by a virus or bacteria, and that fungal meningitis is rare. It is usually caused by the spread of a fungus through blood to the spinal cord.
Symptoms can develop slowly; periods between injection and onset of symptoms may be longer than 1 to 4 weeks, and patients should watch for symptoms for several months. Those symptoms might include:
Contact Laurel Andrews at laurel(at)alaskadispatch.com